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COVER STORY

04-05-2012

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Briefing

Patent to plunder

AMIT SENGUPTA cover-story

India's efforts to produce and supply life-saving drugs at affordable prices face challenges from multinational companies trying to evergreen their patents.

THE average life expectancy across the globe has increased from around 30 years a century ago to over 65 years today. This has been made possible in large part by modern medicine. Never before in history have humans had access to such an array of medicines and devices to treat and ameliorate illness. These advances have also created a new terrain of conflict. While the knowledge required to promote health has expanded enormously, paradoxically, so have the attempts to restrict access to such knowledge.

The current regime of intellectual property rights (IPR) seeks to exercise monopoly control over the production and reproduction of knowledge. Consequently, products to treat a range of diseases are denied to those who need them the most merely because they cannot pay for them. It is denied to them not because these medicines cannot be produced at a reasonable cost but because a few corporations treat the knowledge as their property and sell these medicines at exorbitant prices. They also use the monopoly created by patents to prevent other companies from producing and selling these drugs at much lower prices.

Nothing illustrates this better than the impact of the human immunodeficiency virus/acquired immune deficiency syndrome epidemic in Africa. In 2001, the annual cost of treating one HIV/AIDS patient was $10,000. Some African countries would have had to spend more than half their gross domestic product to procure these medicines for those who needed them. The tragedy is that these medicines need not have been so expensive. In 2003, the Indian company Cipla finally started selling the same medicines at $250 per annum at 1/40th the earlier cost. Even this price was high, and the same drugs can be bought today at less than $100 for a year's supply.

Between 1972 and 2005, India had one of the most progressive patent laws in the world. It was precisely in this period that the domestic drug industry became a global force and is now the third largest (by volume) producer of drugs in the world. The signing in 1994 of the World Trade Agreement [Uruguay Round] which became the World Trade Organisation (WTO) in January 1995 marked India's accession to a global patent regime. India's earlier law, the Patents Act, 1970, worked on a very simple principle. It argued that patents (a monopoly over the manufacture and distribution of a product) would not be allowed in the two most vital areas of human existence food and health. New medicines could be manufactured by Indian companies without hindrance. This is why Cipla was able to manufacture and supply HIV/AIDS medicines at a fraction of the earlier prices. Much of this enabling environment for Indian companies changed when India amended its Patents Act in 2005 after completing the 10-year transition period allowed when India signed the WTO agreement.

However, Parliament, while amending the Patents Act to conform to the obligations set by the WTO agreement, introduced a number of health safeguards. These were designed to mitigate the impact of a patent regime that denied Indian companies free access to available knowledge. Two recent developments are now poised to test the ability of the domestic law on patents after the 2005 amendments to actually secure access to medicines.

The Indian law faces a challenge from the Swiss drug maker Novartis. At the heart of the challenge lies the vital anti-leukaemia (blood cancer) drug called imatinib mesylate. The drug was introduced in 2001 and has quickly become the key drug used to treat a form of leukaemia called chronic myeloid leukaemia (CML). For patients suffering from CML, the drug is the difference between a healthy life and a death sentence.

Imatinib mesylate has been patented in many countries by Novartis, which sells the drug under the brand name Glivec (or Gleevec). The patent application for Glivec was rejected in 2006 by the Indian patent office, which upheld the contention of Indian generic companies and of the Cancer Patients Aid Association (CPAA) that Glivec was not a new drug and did not merit grant of a patent.

Novartis persisted in its efforts and appealed to the Intellectual Property Appellate Board (IPAB). In June 2009, the IPAB upheld the decision of the patent office. Simultaneously, Novartis filed two writ petitions in the Madras High Court, one challenging the decision of the patent office and the other challenging Section 3(d) of the Patents Act. In the latter case, Novartis claimed that the section was in violation of India's obligations to the WTO. The Madras High Court rejected both these appeals. It pointed out that domestic courts could not be asked to give an opinion regarding international treaties and obligations and that Novartis should take its complaint to the disputes settlement mechanism in the WTO. Novartis has never done so, and clearly Section 3(d) does not violate international obligations.

It is important to understand why courts and the patent office have repeatedly turned down Novartis' request for a patent. The original patent on Glivec was filed by Novartis in 1993 for the amorphous molecule of the chemical imatinib mesylate. An amorphous salt is what exists in nature and is a mixture of different variants. In the late 1990s, Novartis filed a fresh patent for the beta variant of the molecule, which is already present in the amorphous salt patented earlier. It also claimed that the beta variety was better absorbed in the body and was more stable. The 1993 patent was not recognised in India as at that time Indian law did not allow the patenting of medicines.

When the law was changed in 2005, Novartis applied for a patent for the beta variety of the salt. The patent office refused a patent on a number of grounds. It said that under Section 3(d) a slightly modified version of a known molecule could not be patented. Section 3(d) stipulates that trivial changes in existing molecules cannot be candidates for fresh patenting. Such trivial patenting (known as evergreening) is an old ploy used by drug companies to extend their monopoly. Companies first apply for a patent for the basic molecule and then attempt to extend the life of their monopoly by applying for fresh patents after a few years on a slightly different version of the original molecule.

The patent office also said that the patent application did not fulfil two necessary criteria for patenting novelty (that is, it should be a new compound) and inventive step (that is, it should involve an inventive state that is not anticipated by someone well versed with the technology). Both the patent office and the IPAB invoked Section 3(d) to deny Novartis' appeal.

Novartis is now arguing its case in the Supreme Court through a special leave petition challenging the IPAB's interpretation and application of Section 3(d) to its patent application, and final arguments on the case are to commence on July 10, 2012. Instead of challenging Section 3(d), Novartis now argues that the section has not been properly interpreted. The section says that minor variations in an existing molecule cannot be patented unless there is a significant enhancement in the efficacy of the medicine. Now Novartis claims that since the beta variant is better absorbed (by about 30 per cent) it constitutes a significant enhancement. Novartis' panel of expensive lawyers is led by Gopal Subramaniam, who was the Solicitor General of India (and hence technically responsible for leading the government's defence) when Novartis first approached the Supreme Court.

Claims of altruism

How much would Novartis gain if its patent were to be upheld? The arithmetic speaks for itself. A month's supply of Glivec costs Rs.1,20,000 way beyond the means of more than 99 per cent of Indians. Remember that the drug has to be taken lifelong. Yet the same drug is sold by several Indian companies at Rs.8,000 for a month's supply 1/15th of what Novartis charges. At the heart of Novartis' battle is a $4-billion-plus global market for Glivec about Rs.20,000 crore, which is equal to the entire Union health budget of India for 2010-11.

Novartis claims that price is not an issue in India because eligible patients are covered by a programme called GIPAP Glivec International Patient Assistance Programme. The only problem with Novartis' spin on the issue is wrong arithmetic. Novartis claims that it supplies the drug free of cost to about 11,000 leukaemia patients in India. The CPAA estimates that there are over 100,000 patients in India who suffer from CML and that 20,000-odd new patients are added every year (the disease has an annual incidence of 1-2/100,000 population a year). Studies also show that the disease strikes earlier in life in India in a younger age group than in Europe and North America.

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Novartis has regularly claimed credit for its GIPAP programme. How altruistic is the GIPAP programme? The programme was launched in 2002, and Novartis claims that it reaches 35,000 patients in 80 countries. In 2003, The New York Times carried an investigative report that blew the lid off the claims of altruism. The report (as well as another report from Argentina) documents how GIPAP has been used by Novartis to first create a demand for Glivec and then to pressure governments and health management organisations to reimburse its cost. The report stated: In wealthier countries like South Korea, Hong Kong and New Zealand, Novartis, meanwhile, has encouraged patients who have received free drugs to become advocates, pressing public health systems to pay high prices for the drug. One company document declared that drug donations along with media campaigns and legal tactics were part of a concerted plan to win reimbursement for Glivec.

Novartis says that it is not fighting the case to make money but to uphold the principle that it deserves credit for the investment it made in research to develop the drug. What Novartis does not tell us is that Glivec was granted orphan drug status in the U.S. and was therefore eligible for tax rebates equal to half the cost of clinical testing (the major cost of drug development).

Brian Druker, one of the scientists involved in developing imatinib while working in Oregon Health and Science University Knight Cancer Institute, commented in a signed article in Livemint in 2007: My work in Oregon on a therapy for CML was primarily funded by public sources, particularly the National Cancer Institute. My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the development of imatinib on their agenda despite uncertainty from product managers. As imatinib progressed through early and late clinical trials and demonstrated outstanding results, scientific and media interest in our discovery increased. The approval of imatinib by the FDA [the U.S. Food and Drug Administration] in May 2001 for use in CML was the culmination of a 10-year project for me, something I had dreamed of since medical school. And yet, Novartis laments that it is not being given due credit for its original research.

India breaks a patent

In March 2012, the Indian patent office issued a compulsory licence (CL) to the Indian generic drug company Natco Pharma Ltd for Bayer's anti-cancer drug sorafenib. The licence was issued under Section 84 of the Patents Act. It breaks Bayer's monopoly over the drug, and Natco can now manufacture and sell the drug in India.

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Sorafenib has been shown to extend survival rates among those suffering from hepatocellular carcinoma (liver cancer) and renal cell carcinoma (a form of kidney cancer). At present, Bayer's version of the drug costs Rs.2,80,000 a patient a month. Natco will make the drug available at a cost of Rs.8,800 a month, a 97 per cent reduction on Bayer's price.

The decision has been followed by reverberations across the world. A range of people working on public health and access to medicines issues have welcomed the decision of the Indian patent office. The fact that this is the first CL issued in India is in itself a major step and can be a precedent for many more CLs in the future.

The CL on sorafenib not only helps cancer patients who require the drug but is also a step towards building domestic manufacturing capacity and knowhow in a new range of anti-cancer drugs. Sorafenib is one of the first in a group of new drugs that specifically target cancer cells. Similar drugs with better results are likely to be available over time, and it is important that generic manufacturers develop capacity to manufacture these.

Patents are supposed to represent a balance between the rights and obligations of a patent holder. Patent laws are required to ensure that the products of new research are available to the largest number of people, while providing a fair return to the innovator. Compulsory licensing is a key instrument incorporated in patent laws to maintain this balance. It allows regulators to break the monopoly of a patent holder by allowing a third party to use the patent in situations where the patent holder abuses the monopoly right to deny access to its innovation to a very large number of people.

The 2005 Patents Act provided broad grounds for issuing a CL, including (a) the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) it is not available to the public at a reasonably affordable price, or (c) the patent is not being worked. By pricing its drug at almost Rs.3 lakh for a month's treatment, Bayer was denying access to the drug to thousands of cancer patients in the country.

Decisive battle?

The two developments have several long-term implications for India's domestic drug industry. Novartis is challenging the very heart of the Indian Patents Act and its attempt to balance the rights of patent holders with the needs of the Indian people for access to treatment that is affordable. Section 3(d) of the Act has been used several times by the Indian patent office to deny patents for other similar trivial inventions, especially in the case of HIV/AIDS medicines. If the section is diluted or overturned, all these cases will be reopened. Not just that, it will open the door for a flood of applications, many of which were not filed by companies because of the existence of Section 3(d).

The case has implications not just for leukaemia patients but for a whole range of patients who are today able to access cheaper drugs made by Indian companies. These patients are located not just in India but in over a hundred countries in Asia, Latin America and Africa. For example, over 80 per cent of all patients in developing countries who consume HIV/AIDS medicines are able to do so because Indian companies supply them these medicines at affordable rates. This is a case that Novartis must not win because it is not about corporate pride. It is a case that sets corporate greed against the lives of millions across the world.

It is useful to recall that the Madras High Court, while rejecting Novartis' appeal, had said: We have borne in mind the object which the Amending Act wanted to achieve, namely, to prevent evergreening; to provide easy access to the citizens of this country to life-saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.

The first grant of a CL in India has clear implications for the availability of new drugs at affordable costs, not just in India but in many developing countries. Compulsory licence provisions exist in the laws of most countries, but they are rarely used. As a result, only a few countries have issued CLs since 1995. Most of these have been for HIV/AIDS medicines and almost all have been for use by the government or in situations where a government has declared a national emergency (as in the case of the HIV/AIDS epidemics in Africa). The U.S. and the European Union, acting at the behest of their pharmaceutical industries, have brought extreme pressure to bear upon developing country governments to dissuade them from issuing CLs.

What is extremely significant in the case of the sorafenib CL in India is that it is a rare instance when a general CL has been issued, not bound by government use provisions or provisions allowed only in cases of extreme urgency or national emergency. This has the potential to expand the scope of CLs vastly, in terms of both the kind of drugs for which they can be issued in the future and the conditions under which they are issued.

Further developments in both these areas will be closely watched as they will determine whether India can continue to be known as the pharmacy of the South with the ability to produce and market new drugs at prices people in most countries in the developing world can afford. We may well be watching the decisive battle against patent monopolies that have, for too long, erased the benefits of scientific advances in health care across the world.

Dr Amit Sengupta is with the All India Peoples Science Network and the Jan Swasthya Abhiyan.

Section 3(d)

cover-story

Section 3 of the Indian Patents Act, 1970, lists what are not inventions. The relevant subsection (d) after it was amended in 2005 reads:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Before 2005, subsection (d) read thus:

the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

A big step forward

C.P. CHANDRASEKHAR cover-story

That this is the first time a compulsory licence has been granted in India is in itself important.

INDIA'S long struggle to ensure access to affordable medicines for its people recently took a positive and interesting turn. In early March, just before he demitted office, Controller General of Patents P.H. Kurian passed an order on an application filed by Natco Pharma, headquartered in Hyderabad, requesting a licence to produce an anti-cancer drug (sorafenib tosylate), the patent for which is held by the German pharmaceuticals and chemicals giant Bayer. It produces and markets the drug under the brand name Nexavar, which is used in the treatment of patients diagnosed as being in the advanced stages of affliction with liver or kidney cancer. Having failed to obtain a voluntary licence for manufacture from Bayer, Natco had filed an application under Section 84 of the Indian Patents Act, which specifies the conditions under which a compulsory licence (CL) may be issued to a producer other than the patentee. Compulsory licensing involves providing an agent, other than the holder of the patent for a product or process, permission to produce or market that product without the consent of the patent holder.

Before 2005, when India amended its Patents Act to recognise product patents, Natco or any other Indian pharmaceutical company would not have needed such permission. All it needed to do was demonstrate that it had access to a process technology different from that used by Bayer to produce sorafenib. This encouraged the growth of an industry producing a large number of on-patent (and off-patent) drugs and marketing them at prices much lower than those charged by the original patentees. The net result was the well-documented fact that drug prices in India were among the lowest in the world and there was no shortage of essential drugs in the country.

However, once India signed into the Uruguay Round Agreement, which included an agreement on Intellectual Property Rights (IPR), India's Patent Act, 1970, had to be amended thrice, in 1999, 2002 and 2005, to bring it in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These changes not only replaced the chapter on CLs but culminated in the recognition of product patents. Inasmuch as the latter prevented Indian firms from producing a patented product (unless the technology was voluntarily licensed by the patent holder) and gave the patent holder a monopoly right to produce the product, there was a danger that prices of medicines would rule high and attempts to regulate or control them could lead to inadequate availability of medicines.

The TRIPS Agreement was to the disadvantage of less-industrialised developing countries like India, which had registered few patents, including in a crucial area like pharmaceuticals. However, the TRIPs Agreement did provide a few windows of opportunity for governments to intervene to rein in prices in support of needy patients in their countries. Crucial among them was the right (subject to conditions) that the agreement granted governments to resort to compulsory licensing on grounds such as the public interest, anti-competitive conduct, or need for non-commercial government use. It was that right that the clauses on CL in the revised Patent Act sought to interpret.

What constitutes public interest is an issue of significance . In principle, the right of the government to resort to compulsory licensing can be invoked when the patent holder does not work the patent or does so in a manner that is inimical to the public interest, leading to unreasonable prices, inadequate technological progress, or inability to deal with public health or other emergencies. However, the TRIPSAgreement did require that the patentee should be notified about possible violations and the prospect of issue of a CL and that negotiations should be held with the patentee to resolve the issue if possible.

In the case of pharmaceuticals, this right to issue a CL was strengthened under pressure from developing countries and civil society activists in the Doha Ministerial Declaration of 2001. The Declaration on the TRIPS Agreement and Public Health of 2001 affirmed the power of WTO members to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted and held that the agreement can and should be interpreted and implemented in a manner supportive of WTO Members' rights to protect public health and, in particular, to promote access to medicines for all.

In India these flexibilities became a matter for debate before the revision of the Patents Act was legislated to make it TRIPS-compliant, leading to major advances. One of those advances is the stipulation that a CL can be invoked also in instances where not only the patented product is not reasonably priced (say, relative to costs) but also the price is not reasonably affordable. Section 84 of the Indian Patents Act says: At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely: (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.

What was unclear was how the presence or absence of such grounds for action were to be assessed. Remarkably, after India amended its Patents Act to make it TRIPS compliant and recognise product patents, the government had not, until now, exercised the right to compulsory licensing even once, which would have helped clarify matters. This is despite the fact that in a crucial public health-related area such as drugs and pharmaceuticals the transition to the new regime made a considerable difference to both availability and affordability.

Being the first in itself makes the Nexavar judgment historic. But there is more to the judgment than its pioneering character. It is the grounds on which the Controller of Patents accepted Natco's application and rejected Bayer's opposition that are also path-breaking. One important ground was the assessment whether reasonable public requirement was being met with regard to the supply of Nexavar through importation. Noting that: (i) over the years, Bayer had imported the drug in volumes that could have treated only a small fraction (a little above 2 per cent) of those who could be credibly assessed as requiring the drug; (ii) that there were years in which no imports were made; and, (iii) that the company was relying only on the import route and not on local production to work the patent, the Controller General concluded that in a physical sense Bayer was not working the patent. It was not meeting the condition that the reasonable requirements of the public with respect to the patented invention were being satisfied.

He also rejected the argument that these circumstances with respect to supply of Nexavar had to be judged in the context of the fact that Cipla, another domestic generic pharmaceuticals manufacturer, has without licence been marketing sorafenib in India at a price much lower than that charged by Bayer. Bayer has filed an infringement suit against Cipla, which is pending in the courts. In the circumstances, the Controller General argued that this could not be an excuse for Bayer not ensuring adequate supply of Nexavar.

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A second important conclusion of the Controller is that the failure to meet demand adequately was partly caused by the high price of the product, which made it unaffordable. While Natco's counsel referred to research findings on reasonable estimates of R&D costs and the per capita incomes of the poor in India to argue that the product was unreasonably priced, the judgment itself focussed on the issue of unaffordability. Even when assessing this, the fundamental issue was not the fact that Nexavar was being priced at around Rs.2.8 lakh for a month's dosage of 120 tablets, when Cipla was supplying the drug at Rs.30,000 for a month's treatment, and Natco was promising the same quantum at Rs.8,800 if granted a licence.

Rather, starting from the fact that the sale of Nexavar over the previous four years was only equivalent to a fraction of the public's estimated requirement of this life-extending treatment, Controller General Kurian concluded that the drug was not bought by the public due to only one reason, that is, its price was not reasonably affordable to them. This is an important precedent, since it lays down a condition for assessing affordability. If enough of a patented drug that is crucial for the public is not being actually consumed, it must reflect the fact that a significant share of patients are not able to afford the drug at the price at which it can be sold. That does warrant invoking the right to issue a CL.

Finally, the judgment examined the issue of whether the patent was being fully worked in India, given that it was only being imported and not manufactured in the country. Counsel for Bayer referred to the fact that the phrase manufactured in India was dropped from the Patents Act when it was amended in 2002, to argue that local manufacture was not required to establish working of a patent.

Moreover, Bayer's counsel argued, cost-effective scales of production of the drug were far above India's requirement. This precluded local manufacture, in which quality control was also difficult to ensure. Not accepting this argument but recognising that the Act does not define the phrase worked in the territory of India, the judgment turned to international conventions and the fact that the issue of local manufacture though removed from one context when the Indian Patents Act was amended was incorporated in another clause (Section 84(1)(c)).

There are three points the judgment makes here. The first is that while importation rather than local manufacture is not a ground for forfeiture of a patent, a country may use the discretionary powers it has when framing patent legislation to make it a ground for invoking the right to compulsory licensing. Second, the understanding of working the patent in the relevant conventions does not imply working the patent on a commercial scale. And, finally but most importantly, mere importation cannot amount to working of a patented innovation.

According to the judgment, a patentee is obliged to contribute to the transfer and dissemination of the technology, nationally and internationally, so as to balance rights with obligations. A patentee can achieve this by either manufacturing the product in India or by granting a licence to any other person for manufacturing in India. This conclusion, if sustained, is also a precedent with implications that go far beyond this case and product.

On these grounds the Controller of Patents issued an order giving Natco the right to manufacture and sell a generic version of sorafenib tosylate, subject to pricing it at Rs.8,800 for a monthly dose of 120 tablets and the payment of 6 per cent royalty on the net sales to Bayer.

As noted earlier, this judgment does mark a whole new phase in India's journey to fashion a patenting regime that would make medicines affordable to the common man. It is bound to be a precedent that will be quoted in a range of other cases and products. This is not because this is the first instance of grant of a CL, which itself is important. The failure to resort to compulsory licensing thus far was not because of lack of global precedent. In fact, developed countries such as Canada, the United Kingdom and Italy and developing countries such as Brazil, Thailand, Malaysia, South Africa and Kenya have resorted to such licensing in the case of drugs and pharmaceuticals. Very clearly, ideology and international pressure had held back the system.

Controller General Kurian has initiated the process through which India can free itself of such fears and exercise its legitimate rights and options. The nation owes him much.

Patents and the law

V. VENKATESAN cover-story

The implementation of Patents Act, as last amended in 2005, raises significant issues of immediate concern to patients across the world.

INDIA'S Patents Act has an interesting history. Enacted first in 1911 as the Indian Patents and Designs Act in the colonial era, it primarily addressed the interests of inventors, who did not want their inventions infringed upon by anyone who copied them or adopted the methods used to make them. Independence in 1947 evoked new concerns about the Patents Act which were not anticipated in 1911. One of the realisations was that the old Act did not adequately take into account the substantial changes in the political and economic conditions of the country over the decades. These changes necessitated that patent rights were not enforced to the detriment of the consumer or to the prejudice of trade or industrial development of the country.

Although efforts to reform the Act began immediately after Independence, they bore fruit only in 1970, with the enactment of the comprehensive new Patents Act replacing the 1911 law. The Act has been amended five times and the last three amendments (1999, 2002 and 2005) are significant: they were necessitated by India's membership of the World Trade Organisation (WTO) and the resultant compulsion to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS requires that a 20-year patent protection be available for all inventions, whether of products or processes, in almost all fields of technology. The unamended 1970 Act ensured only process patent for food items and medicines. This meant that non-inventors could make these products by a different process and maintain a steady supply in the market.

India had to amend its Patents Act to recognise product patent in the case of pharmaceuticals. This meant that manufacturers of medicines could secure monopoly rights over their products and increase their prices arbitrarily. However, both TRIPS and the 2001 Doha Declaration on the TRIPS Agreement and Public Health recognised the need for certain flexibilities within the Patents Act to cater to the interests of poor patients who could not afford the high cost of pharmaceutical products. India also had the advantage of a longer transition period (10 years from 1995 when India acceded to the WTO) before introducing product patents from January 1, 2005.

But this advantage came with an obligation to introduce three crucial amendments to the Patents Act. First, India had to permit product patent applications to be filed from January 1, 1995 (called the mailbox provision). Thus, if a product figuring in these applications was granted a patent in any of the WTO-member countries and the product had obtained marketing approval in those countries, then India had to grant five years of exclusive marketing rights (EMRs) before it granted or rejected the patent on the product.

The second set of amendments included redefining what is patentable, extension of the term of patent protection to 20 years and amending the compulsory licensing system, which was notified in 2002.

The third amendment introduced a product patent regime from January 1, 2005, in areas, including pharmaceuticals, which were earlier governed by process patents. Provisions relating to opposition to the grant of patents also formed part of the third amendment. Post-2005 is the story of how India has been balancing the need to strengthen the rights of patent holders with the duty to effectively address public interest concerns. A serious concern is how to ensure access to medicines at affordable prices by enforcing adequate safeguards in the implementation of the Act.

One such safeguard is Section 3(d) of the Patents Act, explaining what is not an invention, and therefore, non-patentable. This provision was substituted through the 2005 amendment.

Section 3(d) says, The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in the new product or employs at least one new reactant.

The Explanation to this provision says: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Section 3(d) aims to prevent evergreening. According to Shan Kohli, a blogger at spicyipindia.blogspot.in (posted on November 2, 2011), it states that only those pharmaceutical derivatives that demonstrate significantly enhanced efficacy are patentable. But this provision has been subjected to serious challenge by patentees and defended by those who oppose grant of patents on ineligible grounds.

Barring a Madras High Court decision in the Novartis case, which attempted to interpret Section 3(d) in the context of a constitutional challenge, there has been no case interpreting the scope and ambit of Section 3(d). According to intellectual property law expert Shamnad Basheer (see interview), the Supreme Court lost a fabulous opportunity to do so in Roche vs Cipla, and it is now hoped that we shall have some clear standards emerging from the Supreme Court in the Novartis-Glivec matter.

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Roche, a multinational drug manufacturer, first dragged Cipla, a generic drug manufacturer, to the Delhi High Court alleging that Cipla had infringed upon its patent rights for Tarceva, an anti-cancer drug. Justice Ravindra Bhat of the High Court refused to injunct the defendant Cipla on the grounds that the company supplied drugs at affordable prices and therefore granting injunction was against the public interest.

Roche then appealed to the Division Bench of the High Court, whose order proved only much more detrimental to Roche. On April 24, 2009, the Bench, comprising Justices A.P. Shah and S. Muralidhar, rejected the appeal and imposed costs of Rs.5 lakh on Roche. It also ruled that the patent in question did not seem to be implicated by Cipla's generic product. In any case, Roche's patent was susceptible to a serious validity attack. Roche then appealed against the Division Bench order in the Supreme Court. But the Supreme Court refused to examine the issue as the challenge to Roche's patent had proceeded to trial on final merits. The Supreme Court did not want to delay the trial.

Whatever the result of the challenge to Roche's patent, it is clear that Section 3(d) has been critical in filtering out frivolous patent claims. However, for this to become successful, it is important that generic manufacturers use other provisions, namely, the pre- and post-grant opposition to the grant of patents effectively.

A study carried out by Shamnad Basheer and his research associate, Souvik Guha, in September 2009, found the following:

The total number of pharmaceutical applications filed between 2005 and 2008 were around 9,719. The number of pharmaceutical patents granted during the above time frame was around 2,734. Of the 9,719 pharma applications filed, only 34 were challenged an abysmal 0.3 per cent.

Out of the 34 challenges, one was a post-grant opposition (in favour of Roche covering Pegasus) and the remaining 33 were pre-grant challenges.

Twenty-five of the 34 oppositions resulted in rejections, that is a significantly high ratio of 73.5 per cent. The patent applicant won in only nine cases. Twenty out of the 25 rejections were on the basis of Section 3(d). In other words, 80 per cent of the rejections were made invoking Section 3(d), indicating the efficacy of this controversial section.

According to Shamnad Basheer, the generic industry and public health groups are still coming to grips with this powerful mechanism and are taking some time to leverage it. Patent offices, even in the United States and in the European Union where the offices are better staffed than in India, are fallible. Therefore, he says, they must come forward and leverage the opposition mechanism to help the Indian patent office make the right decision, granting patents to only meritorious inventions. Perhaps the government ought to set up a committee to study the opposition mechanism and why it has been underutilised. It ought to undertake more awareness drives around patents and the opposition mechanism and provide logistical support, where possible, particularly to non-profit non-governmental organisations, he suggests.

A report in the Mint newspaper has suggested that most of the 25 patent applications rejected under the pre- and post-grant opposition category were made by foreign drug makers, including Novartis AG, Pfizer Inc., Gilead Sciences Inc. and AstraZeneca SA. Most of the oppositions were filed by Indian drug makers such as Cipla Ltd, Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd, and Torrent Pharma Ltd. Other challenges came from non-profit patient groups such Cancer Patients Aid Association, Sankalp and Positive People Living with HIV/AIDS.

According to D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, Shamnad Basheer's study reveals that there are alarming numbers of frivolous patents being claimed in the country. The rate of rejections is very high corresponding to the number of oppositions. Shah said it could be because of poor understanding of these provisions by local companies and patient groups.

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A pre-grant opposition allows one to oppose patent applications filed by an applicant. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. India is the only country which provides for both pre- and post-grant opposition in its patent legislation. By doing so, India put the patent applicant in a disadvantageous position as the entire procedure for opposition to the grant of patents can be brought before the courts. It is, therefore, unfortunate that the stakeholders have not used these provisions to the fullest extent.

The patent office in Chennai had earlier rejected Novartis' patent on the anti-cancer drug, Glivec, following opposition from organisations representing cancer patients, among others. In another case, the patent office rejected Gilead's application for patent for its drug tenofovir in September 2009. It accepted the argument that Section 3(d), which states that patents should not be granted for known substances (including the salts of the known substance) that do not show improved efficacy, should block Gilead's application.

The Brazilian Interdisciplinary AIDS Association (ABIA) and the New Delhi-based SAHARA Centre for Residential Care and Rehabilitation together filed pre-grant oppositions because a patent in India would have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug. In 2008, the Brazilian government declared tenofovir to be of public interest in treating people living with HIV. On June 30, 2009, the Brazilian patent office issued a final refusal of Gilead's patent application for tenofovir disoproxil fumarate (TDF). Brazil will not be able to procure generic versions from India if tenofovir gets a patent in India. On the other hand, if the patent is rejected, Indian generic companies will be able to supply tenofovir to Brazil and other middle-income countries.

Gilead appealed against the patent office's rejection in the Intellectual Property Appellate Board (IPAB). While the appeal was pending, U.S. Commerce Secretary Gary Locke requested his Indian counterpart, Anand Sharma, a few days before President Barack Obama's visit to India in November 2010, that Gilead's challenge to the rejection of its patent covering Viread (Gilead's brand name for tenofovir) receive fair consideration. Observers reacted strongly to this, saying that any country, including the U.S., would have raised an objection had the Government of India taken up such corporate issues with its judicial mechanism. They felt India should have discarded the U.S. plea immediately, saying that the patent tribunal here was strong enough to decide such matters independently.

The U.S. intervention also raises the question whether the IPAB, a specialised IP tribunal tasked with dealing with certain kinds of IP disputes, is truly independent. It effectively replaced the functions of the High Court, insofar as a large range of IP disputes were concerned. At the height of the controversy, SpicyIP blog asked: Is IPAB seen as just another wing of the executive and not as an independent tribunal functioning as an organ of the judiciary?

Land of plenty

West Godavari district, irrigated by two mighty rivers, is on the road to agricultural prosperity thanks to various schemes.

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WEST Godavari district, nestling between the mighty Krishna and the Godavari rivers in the coastal Andhra region of Andhra Pradesh, finds itself on the road to prosperity. It is bounded by Khammam district in the north, East Godavari district in the east, the Bay of Bengal in the south and Krishna district in the west. According to the 2011 Census, the district has a population of 39,34,782, of which 19.74 per cent is urban.

Eluru, the district headquarters, was once part of the Buddhist kingdom of Vengi. The Eastern Chalukyas ruled the Andhra region with Vengi, now called Pedavegi, as their capital.

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West Godavari district, with an area of 7,700 square kilometres, was carved out of the old Godavari district in 1925. The barrages built across the Godavari and the Krishna by Arthur Cotton, the British general and irrigation engineer, supply water from the two rivers through irrigation canals, bringing prosperity to the farming community in the delta region. West Godavari is endowed with three natural regions the delta, the upland and the Agency area. The district's landscape is picturesque. There are lush green agricultural fields, the Kolleru lake hosts a range of resident and visiting birds, and the Godavari meanders through the Papi hills.

Paddy, cultivated over 5.29 lakh acres (one acre is 0.4 hectare), is the principal crop in the delta region. This is followed by lemon and coconut. Aquaculture is also done on a large scale. Around 50 per cent of the State's rice stocks come from the district. Hence it is called the rice bowl of Andhra Pradesh. A large portion of the fish and prawns produced in over one lakh acres in the delta is exported to Bangladesh, Japan and the United States. Horticultural crops such as oil palm, mango, cashew and banana are grown in the upland region. West Godavari's tobacco, which is cultivated on 50,000 acres in the northern light soil (NLS) area, enjoys a special place in the international market for its unique flavour.

The district administration, headed by Collector G. Vani Mohan, is striving to achieve inclusive growth in the farm sector with the focus on tenant farmers, who do more than 80 per cent of the agriculture. The administration has distributed 85,000 loan eligibility cards (LECs) and arranged for the disbursement of bank credit worth Rs.80 crore to the cardholders during the kharif and rabi seasons.

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The paddy procurement centres run by women volunteers of the Indira Kranti Padham (IKP) offer a helping hand to paddy growers, who used to be at the mercy of millers. The role played by the women in the purchase of more than 20 per cent of the total produce in kharif-2011 through 70 procurement centres operating side by side with private traders provided the growers the much needed relief from market shocks. The Collector told Frontline that the administration planned to increase paddy procurement in the next kharif season to five lakh tonnes, that is, nearly 50 per cent of the total produce.

The district has been passing through a critical phase on the agricultural front this year in view of the dwindling water levels in the Godavari, on the one side, and the acute drought conditions, on the other. The water crisis in the river has resulted in a crop holiday in 2.5 lakh acres in the delta in the rabi season, which means a steep fall in paddy production in the current rabi. The district administration stood by the farmers in handling the crisis, motivating them to switch to alternative crops and providing them seeds at subsidised rates. Fifteen mandals were declared drought-hit. Crops in five mandals, spread over 2,716 hectares, were damaged completely. The crop loans of drought-hit farmers have been rescheduled as part of the drought-relief measures. Over one lakh jobless farmhands have been provided employment in works, together worth Rs.5,920 lakh, taken up under the Mahatma Gandhi National Rural Employment Guarantee Scheme.

A contingency plan has been drawn up to handle the drinking water problem arising out of the drought conditions. Ten delta mandals reeling under the crop holiday and 15 drought-hit mandals are prone to drinking water shortage. The Rural Water Supplies Department is planning to fill the summer storage tanks and supply water to the problem areas in tankers.

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The official machinery is executing the Rs.1,400-crore delta modernisation project in mission mode. It aims at widening, deepening and strengthening canals and drains under the Vasista, Kolleru and Upputeru basins to save farmlands from devastating floods.

Indira Sagar Project

The district is poised to become a launch pad for another round of Green Revolution in the coastal region, with the Indira Sagar Project under construction across the Godavari near Polavaram. The project is designed to irrigate 7.2 lakh acres in East Godavari, West Godavari and Krishna districts, apart from transferring the river's waters to the Krishna while augmenting drinking water supply in Visakhapatnam, through the Right Main Canal and the Left Main Canal. The administration is implementing the relief and rehabilitation (R&R) package for 21,800 project oustees from 26 affected villages.

Welfare mission

The District Collector initiates a welfare programme to improve the quality of life of the poor and needy.

ABHILASHA, the flagship programme of the West Godavari district administration, has brought all-round cheer to the poor and downtrodden. District Collector G. Vani Mohan, who conceived of the initiative as a trust in support of better hospitals, hostels, animal health and disabled welfare, has been drawing support from different walks of life. From people's representatives to corporates to ordinary housewives, everybody has added their mite to the corpus fund of the programme. When I started the project, I had virtually no money. Now, support is pouring in from different sections of society, Vani Mohan told Frontline.

The programme aims at improving the infrastructure of and medical equipment with the primary health centres (PHCs), the community health centres (CHCs), the area hospitals and the veterinary dispensaries in an attempt to ensure quality life for the poor. Three Lok Sabha members representing the district Kavuri Sambhasiva Rao (Eluru), Kanumuri Bapi Raju (Narsapur) and Undavelli Arunkumar (Rajahmundry) have contributed Rs.30 lakh from the Member of Parliament Local Areas Development Scheme (MPLADS) funds to purchase ambulances and start blood banks in Bhimavaram, Jangareddygudem and Eluru. Some housewives of Eluru have raised funds through kitty parties for the programme. GAIL has offered Rs.11 lakh for strengthening the veterinary hospitals.

Most of the health centres and veterinary dispensaries in the district are plagued by poor facilities. Moreover, the economically backward people are not in a position to receive quality health services from the private dispensaries. Abhilasha intends to give a facelift to all the 73 PHCs, 19 CHCs, three area hospitals, 14 veterinary hospitals, 86 dispensaries, 103 rural livestock units, and 117 social welfare hostels housing 27,000 students in the district, the Collector said. She said that 30 per cent of the hospitals did not have doctors while 50 per cent of them had no specialists. The district administration is planning to provide better facilities in the hospitals with an assistance of Rs.50 crore from the National Rural Health Mission.

The programme aims at providing artificial limbs, tricycles, wheelchairs, hearing aids, crutches, calipers, walking sticks and Braille slates (for the visually challenged), blood storage units, ultrasound equipment, ventilators, incubators, oxygen cylinders and surgical equipment in the PHCs and the CHCs, and artificial insemination facilities in the veterinary dispensaries.

Abhilasha also aims at creating a home away from home for students staying in the government hostels by improving basic amenities and comforts there and providing water filters, toilets, bathroom blocks, drainage facilities, fans, and so on.

The trust will help poor meritorious students passing out of schools run by the government and the local bodies and provide them with quality education and financial support. Similarly, it will enable meritorious students staying in social welfare hostels to get admission in premier institutions. Education and health are my focus areas, the Collector said. The administration is planning to create a health profile of all schoolchildren from classes I to X in the district. The children will undergo a series of screening tests such as blood tests and haemoglobin tests as part of the programme.

The administration is contemplating the development of a software to monitor the performance of 12,000 teachers in 4,000 schools as part of the drive to improve the quality of teaching and learning. Abhilasha has also come as a blessing for prison inmates. The programme plans to bring prisoners into the mainstream by promoting skill development in a slew of trades. It is proposed to hold a series of training programmes for them as part of the endeavour.

The Abhilasha programme was launched on June 8, 2011, also to give a fillip to the dairy industry in the district. The Milk Mission was launched with funds from the Abhilasha programme to provide protein-rich food to below poverty line families by increasing their per capita milk consumption, which is 120 ml as against 260 ml recommended by the World Health Organisation (WHO). As part of the endeavour, milk production is proposed to be increased to three lakh litres a day. The present production of 1.2 lakh litres is hardly sufficient to meet the requirements of the 39 lakh-odd people in the district.

According to the Collector, the Department of Animal Husbandry is making efforts to procure 5,000 milch animals from Haryana. It is also proposed to establish 27 bulk milk cooling units across the district. Abhilasha tries to mobilise funds to improve infrastructure facilities, such as inpatient sheds and trevis sheds, in the veterinary hospitals.

The district administration has proposed to upgrade the animal disease diagnostic laboratories located in Eluru. The proposal is intended to improve the health of livestock in West Godavari, East Godavari and Krishna districts and ensure sustainable milk production.

Milk production in the region is falling in view of the prevalence of virulent diseases, such as the foot-and-mouth disease, reported in milch animals for want of early diagnosis and quality treatment.

Enduring presence

other

SIR Arthur Cotton, the British engineer who was the brains behind the barrage across the Godavari river near Doleswaram, has been a cult figure in the Godavari region for generations. Temples were built for the man who brought prosperity there and his statues adorn villages. His birthday is celebrated with reverence every year. The Godavari delta, spread over 10.3 lakh acres (one acre is 0.4 hectare) and coming under West Godavari and East Godavari districts, has become a launch pad for the Green Revolution.

The 150-year-old barrage built by Cotton was washed away by floods in 1986, and another bridge was constructed 45 metres upstream. The new barrage, with 175 vents, a prototype of Cotton's brainchild, provides a dead storage of 3 tmc ft and has an ayacut of 10.3 lakh acres spread across the two districts with assured water supply for two crops a year. The old barrage, with a dead storage of 1 tmc ft, was designed to provide water for only four to six lakh acres for a single crop.

The imposing structure has helped harness Godavari water for agriculture and aquaculture. The Godavari is considered a perennial river with inflows from a host of tributaries such as the Shabari, the Pranahita and the Penganga. The age-old canal and drainage systems designed by Cotton are all set to receive a facelift under a multi-crore modernisation project, which is under way. The drains and canals, which are in bad shape, have become vulnerable to breaches and floods, causing farmers heavy financial losses almost every year. The government has enforced a crop holiday in parts of the delta region in the current rabi season to accelerate the modernisation works. The project is expected to restore the past glory of the delta and save paddy fields from recurrent floods.

The West Godavari district has been undergoing a transformation from agriculture to agro-based industrial activity, with successive generations diversifying into aquaculture, rice milling and other industries after tasting success in paddy cultivation. Of late, lack of remunerative prices, increasing cost of production and soaring labour costs have resulted in distress to the farming community. Evidence of the agrarian crisis manifests in the form of crop holidays in parts of West Godavari district and in the Konaseema region of East Godavari district.

The West Godavari district administration is sparing no effort to bail out agriculture and to protect sharecroppers, who cultivate more than 80 per cent of the agricultural fields. Making bank credit available to a large chunk of tenant farmers through a loan eligibility card (LEC) scheme is the administration's major initiative to address the problem of distress.

Collector G. Vani Mohan asserts that the farmer-induced crop holiday was limited to some extent in West Godavari district because of the LEC initiatives.

G. Nagaraja

Social security

other

EVER since the economy was liberalised in 1991, the working class has been at the receiving end be it in the matter of jobs or social security (Unkind cut, April 20).

EPF has seen a steep fall in interest rates from the initial 12 per cent. The government has turned a deaf ear to the request of Left parties and trade unions to enhance the wage ceiling of Rs.6,500 for EPF, and increase the interest rate. Many employers do not provide the EPF facility to their staff claiming that they pay a salary of Rs.6,500 or more. Only about 4.7 per cent of our population have EPF cover. The government, which refuses to give a decent interest rate to workers, offers many subsidies, tax holidays, exemption from certain labour laws to big industrialists.

Such practices can lead to political unrest. G. Anuplal Bangalore Linking rivers

THE river interlinking project is too big to be successfully executed in a country like India (Mission Impossible, Cover Story, April 20). There are too many hurdles in the way huge costs, land acquisition issues, displacement of millions of people, and so on.

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The big question is whether the government will take such an anti-people stand. When the National Highways Development Project entailing lesser costs could not achieve the desired results, how can the government achieve success with an ultra-mega project such as ILR. And if past records are anything to go buy, such projects result in huge corruption.

Bal Govind Noida

THE problem of water deficit can be solved by rainwater management and economical usage of water. The water quality of one river is different from that of another. Interlinking rivers cause severe damage to biodiversity.

Dr Hem Srivastava Ranchi, Jharkhand

THE Cover Story was very informative. It helped the lay reader understand the reasons behind the delay in the project's execution.

Sujit Ugale Nasik, Maharashtra

WHEN Justice B.N. Kirpal proposed the interlinking of rivers in 2002, he said that it was just a recommendation. But the latest in the string of judgments on this issue does not open even a small window for debate and discussion. Interlinking of rivers is a highly technical matter that needs to be debated by a panel of philanthropists, social scientists, engineers, and so on. It is not something that can be decided by a Bench of judges alone. The Supreme Court has also not taken into consideration any literature on the subject other than the NCAER report.

It has to be seen if the Ministry of Environment and Forests will give the go-ahead for this bizarre project, considering its environmental implications. How can the country even think of embarking upon this project when States are yet to settle river water disputes?

Ritvik Chaturvedi New Delhi

THE Supreme Court has thrown its weight behind a decade-old project, which is being opposed by some States, environmentalists and social activists. In fact, interlinking the country's river system to transfer surplus water to deficit areas through a network of canals was first conceived by the visionary engineer K.L. Rao, who had served in the Cabinets of Jawaharlal Nehru, Lal Bahadur Shastri and Indira Gandhi.

Of India's annual surface water resource of 69,000 tmcft, only 8,800 tmcft is utilised. The rest drains into the sea. Interlinking rivers would help generate more than 40,000 MW of clean and green electricity.

K.S. Jayatheertha Bangalore

INTERLINKING India's rivers is not feasible. Ever since former President A.P.J. Abdul Kalam highlighted the need for such a project and former Prime Minister A.B. Vajpayee popularised it, people began to dream that the nation would be relieved of the problems of floods and droughts and be able to also increase foodgrain production. What they did not realise was that the government announces many plans just to fascinate people and win elections.

Sushil Kumar Aurangabad, Bihar Provident Fund

UNLIKE deposits in banks and other financial institutions, the Employees' Provident Fund is a social security measure (Unkind cut, April 20).

Keeping the interest of workers in mind, the fund was introduced soon after Independence through an Act of Parliament. The employees' money remains with the government during their long periods of service. Since the government invests EPF funds in development schemes, they deserve a higher rate of interest than the usual fixed deposits. The government has hiked the interest rates on post-office small-savings plans by up to 50 basis points for the new fiscal year. In view of the social security of employees, especially in old age, the government must restore the 9.5 per cent interest rate on EPF.

J.S. Acharya Hyderabad

BY reducing the EPF rate to 8.25 per cent, the Union Finance Ministry has dealt a severe blow. It has broken the morale of the poor non-government employees. The Labour Ministry's silence over the issue is intriguing. Hopefully, the Finance Ministry will revoke the notification.

Jayant Mukherjee Kolkata Nuclear power

THE Tamil Nadu government's consent for the immediate commissioning of the Kudankulam nuclear power project in Tirunelveli should be respected and welcomed by all (Full steam ahead, April 20). Unnecessary criticism and protests against industrial projects should not be allowed to ruin the growth of the country. Everyone has a right to protest against any project, but there should be no place for false propaganda. As poet Rabindranath Tagore said, Science has given man immense power. The golden age will return when it is used in the service of humanity.

P. Senthil Saravana Durai Vazhavallan, T. N.

AS long as politicians are not ready to discard parochialism, stage-managed agitations are bound to happen. In Kudankulam, vested interests have exploited the sentiments of the local people. More than the threat of nuclear leak or radiation, what worries some people is the round-the-clock presence of Central security forces in the Kudankulam belt, which will deter the unlawful activities that have been going on in coastal areas around the project site for years together with the blessings of some influential people.

Instead of invoking NSA in September 2011 itself, the Centre chose to remain a mute spectator and unnecessarily allowed the issue to escalate beyond control. This helped the State government to take control of the situation on the grounds that law and order is a State subject.

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The agitation exemplifies the rising clout of States against a weakening Centre, which does not augur well for the federal polity.

Ettirankandath Krishandas Kinassery, Kerala Sri Lanka

INDIA made a wrong diplomatic move by voting in favour of the U.S.-backed resolution at the UNHRC against Sri Lanka (Lessons leant?, April 20). This distortion of India's foreign policy at the behest of the DMK may backfire.

The U.S. has often described India as a Muslim-baiter, citing the Babri Masjid issue. We have unwittingly toed the American line. The country has the habit of bullying its friends and respecting its opponents.

India should have adopted a non-interference policy in the Sri Lankan Tamil issue. If we supported Sri Lankan Tamils to appease the Tamil politicians, then we should concede Pakistan's right to help the Muslims of India. The LTTE was more cruel than the Sri Lankan army personnel. It mercilessly killed former Indian Prime Minister Rajiv Gandhi and many Sinhalese leaders as well as Sri lankan Tamil leaders of moderate groups.

The U.S. backed the resolution not out of any sympathy for Sri Lankan Tamils but out of its need to stop Sri Lanka's efforts to move closer to China. The U.S. also wants to get a foothold in Sri Lanka.

S. Raghunatha Prabhu Thiruvampady, Kerala Vodafone case

MOST review petitions are dismissed by the Supreme Court without assigning any reason, although many of them indeed have valid legal points (A new look at capital gains, Update, April 20). The government may get the better of flawed' court orders by amending the law, but what option is left with the ordinary citizen? The review petitions should be heard by a different Bench in the interest of justice.

Satish Kumar Gajbhiye Nagpur Sachin's century

LIKE Donald Bradman's Test average of 99.94, Tendulkar's record of 100 centuries in Test and one-day internationals might never be broken. (Tons of passion, April 20). We must enjoy his twilight years because there might not be another Tendulkar in the foreseeable future.

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AFTER an agonising wait of 12 months, Sachin finally reached the milestone of scoring a century of centuries. It is a moment of pride for every Indian. We salute the little master for this phenomenal feat and for giving us some extraordinary moments in cricket.

K.R. Srinivasan Secunderabad

ON his 100th hundred, Sachin said that after achieving it he was really thrilled and looked at the dressing room and pointed my bat to the players and also to the Indian flag that I have on my helmet. This statement reveals his love for the country and his sense of camaraderie with his teammates.

N.C. Sreedharan Pallikunnu, Kerala

SACHIN admits that the obsession of others had made his hundredth century very difficult to score. The fact that he scored it against one of the weakest sides in the world did not diminish its significance.

P. Arihanth Secunderabad

THERE have been many Indian cricketers who had passion, hunger and motivation, yet were prematurely and unceremoniously retired or rested during the peak of their careers from different formats of the game. The list is long Anil Kumble, Sourav Ganguly and Rahul Dravid, to name a few. The current IPL series confirms that they still have spark in them.

Sadly, things have boiled down to Let Sachin play for the sake of individual records in a team game, and the rest for the nation. Any other player taking 14 innings to score his first Test century, 76 to score his first ODI century and 33 to go from the 99th to the 100th century, would have been dumped. Sachin could reach this number only because of the selectors' benevolence. In fact, Sachin had equalled Sri Lanka's Aravinda de Silva's world record of appearing in the maximum number of lost matches (163) in 2006 itself.

Varin Dhir Ahmedabad, gujarat

IT is sad that Tendulkar did not come for Dravid's farewell function organised by the BCCI in Bangalore and that Dravid did not attend the felicitation of Tendulkar in Mumbai.

Dravid, who voluntarily quit Test cricket but is ably captaining Rajasthan Royals, and Tendulkar, who does not want to call it a day from first-class cricket and continues to play for Mumbai Indians in IPL-5, are two of India's all-time greats.

S.V. Venkatesh Bangalore Norway

THE column Dangerous Altruism amplifies the concerns expressed through the ongoing shrill public debate on the Bhattacharya children in Norway (April 20). There is an old saying that if you save a life, you remain responsible for that life forever. That premise guides the global child protection plan, which began to be constructed in South Asia in the immediate aftermath of Partition.

In the incredibly more complicated case of Rahat Ara and her children, Prime Minister Jawaharlal Nehru had suggested steps to be followed before handing over children but also made it clear that the state was not and could not be a substitute for a family. Before we decide anything, I should like you to write to our Deputy High Commissioner, . Ask him to make discreet enquiries about these people, Tell him we want to have as much information as possible so as to enable us to decide. We should look at this question from the human point of view. If both the father and mother want these children, I see no justification to keep them here. We may look after them well now, but how can we guarantee any future for them.

Norway, as every other country which has signed the Convention on the Rights of the Child, is duty-bound to protect every child who comes into its care. We now know there are flaws in the way its system operates.

The question that remains unasked is why the Indian Embassy, which is duty-bound to support all Indian nationals, both adults and children, in their time of need, came into the picture only after the President of India called the External Affairs Minister of India, who then called the Norwegian Foreign Minister, to request the return of the children to their family.

If the Norwegian authorities did not do their jobs well, neither did the Indians. We have a family torn, children disconnected from their parents and the relationship between two countries stressed. No one comes out a winner in this.

Vijayalakshmi Balakrishnan New Delhi Fukushima

PRAFUL BIDWAI has said that the world must embrace another energy paradigm (End of an illusion, April 6). But until viable alternatives emerge, developing countries should not abandon the existing energy paradigm. After all, 400 million people in our country do not have access to electricity even today.

Bidwai's conclusion that the Fukushima accident was the most serious ever cannot be accepted. According to AEC Chairman Srikumar Banerjee, not one person died or was affected by radioactivity on account of any nuclear blast in Fukushima. Only a hydrogen blast had taken place owing to coolant failure. It was the combination of a tsunami and an earthquake that claimed thousands of lives in Japan.

K. Ravindran Goundampalayam, T.N. ANNOUNCEMENT

Letters, whether by surface mail or e-mail, must carry the full postal address and the full name, or the name with initials.

Privacy on test

The proposed new law in the U.K. that will permit the monitoring of all Internet traffic, ostensibly to combat terrorism, raises hackles over the right to privacy.

THE 9/11 attacks in the United States undeniably changed our lives in many ways. As a direct consequence of that monumental catastrophe, the U.S. and many other countries rightly became paranoid about security. This affected individuals as well as organisations, causing them considerable inconvenience and loss of freedom in going about their daily chores. Accompanying this obsession with security was the conviction that all communication, in any form, between groups and persons even slightly suspected of terror links had to be monitored even if it was considered impractical to enforce a total ban on such traffic. This soon led to a consensus among nations that all telephonic conversations needed to be listened into, if possible in real time, with greater seriousness than before so that any exchange of data aimed at planning another massive attack was intercepted in time.

It was not as if statutes did not exist permitting government agencies to undertake this sensitive task. For instance, the U.S. had the Communications Assistance for Law Enforcement Act (CALEA), 1994, passed under the Clinton presidency. In the United Kingdom there is the Regulation of Investigatory Powers Act of 2000. Both permit a lot of latitude and invest law enforcement with abundant discretion. In course of time, such laws had to provide for the arrival of newer technology and the phenomenon of social networks, which afforded antisocial elements nearly anonymous avenues to transmit information facilitating crime.

The now popular Skype has emerged as one such efficient and economical means of keeping in touch with the rest of the globe. Facebook and similar forums also provide elements inimical to peace and harmony in society opportunities to communicate clandestinely within their groups of associates. This is the genesis and rationale of a desire of quite a few countries to expand their capacity for snooping with the help of new tools and a fresh legal armoury. If one considers terrorist groups' growing propensity to violence and their capacity to use the latest in communication networks, the establishment's response may not be unreasonable.

However, what has been ignored in the process is the high cost involved in building such counterterrorist prowess, with its attendant denial of funds for development work in the relatively poorer countries. In the somewhat affluent nations, concerns over security override the citizens' need for privacy. This was especially true of the U.S. and the U.K. Authorities on both sides of the Atlantic seemed oblivious to the undesirable consequence of this in the realm of privacy. This trend of huge investment in technology and greater intrusion into the common person's life has continued unabated since then, and the feeble voices against them have been largely ignored. This is unfortunate if one reckons the unabashed official misuse of the capacity to eavesdrop on telephone calls and Internet traffic.

Uninhibited snooping on political rivals by a government is now taken for granted, and denials of charges on this score by the establishment invite only sneers. Watchdogs such as the judiciary have been ineffective in preventing the erosion of the fundamental right to anonymity and privacy because of the sheer inability of victims of state intrusion to prove that they have indeed been vandalised. Such is the power of the state and its sophistication in covering up its transgressions.

Very few countries have a clean record in this respect. The less said about India the better. As in the case of corruption, there are no saints here across the political spectrum. We are aware of the rise of new government outfits solely to upgrade snooping on behalf of the government. This subject has figured repeatedly in Parliament, but the debates have thrown up more heat than light. There is no certainty that parliamentary discussions have had the intended effect of ensuring that there is no intrusion into the people's sacred right to privacy when they lawfully communicate with others.

Monitored telephone calls and e-mails bring in such an abundant plunder of information that political bosses who call the tune at any point of time are extremely pleased with what is produced before them, and the civil service purveyors of stolen information get duly rewarded. This is a drama that passes unnoticed because of the secrecy that envelops the whole process.

This preamble to my column provides the context to a controversy that is now raging in the U.K. British Prime Minister David Cameron is really in a pickle over a reform that will have a far-reaching impact on the values his country has cherished from time immemorial. His coalition government is under fire for proposing a new law that will help official monitoring of Internet traffic in real time. If and when Parliament approves it, the new facility to pry into the Internet will be in addition to the existing power to listen in on telephone calls, of course with due authorisation from the Home Secretary.

This has generated a massive controversy, with the junior partner in government, the Liberal Democrats, distancing itself from the draft legislation. Under the contemplated law, it would be mandatory for Internet Service Providers (ISPs) to allow real-time scrutiny of Internet traffic records by competent government authorities. It is believed that the law would demand revelation of facts of who contacted whom, at what time and for how long. There will be no need for ISPs to make available texts of e-mails. On the face of it, this appears to be an innocuous and a justified piece of help to those charged with the duty of combating terrorism and organised crime. The point that has been raised by many sceptics is whether the current technology is sharp enough to prevent unauthorised exposure of contents of mails. Can there be an unwitting revelation of what requires to remain purely in the private domain? Also, can a rogue in the security services, who has been compromised, gain access to what is written on a mail? Going by the experiences of many of those who have been in government in the past, these misgivings are not ill-founded.

One major difference that the proposed Bill in the U.K. seeks to make from the current regulations is that each ISP will have to store data in a back door into their systems to which the authorised agencies will have free access. The prevailing practice is for the latter to make an application to an ISP seeking information whenever required. Possibly this imposed a certain protocol that inhibited frequent snooping.

The new law dispenses with this rigmarole and allows real-time snooping. The proposed system imposes a certain financial burden on the ISPs which they resent. The whole scene, therefore, reeks with negatives that the coalition government has to battle. It is not clear whether David Cameron will ultimately succeed in pushing this through Parliament, particularly when a few people in his own party have misgivings over the wisdom of creating a law that could become an albatross around their necks.

If this worrying development in the U.K. is not enough, news that comes from the U.S. is of even more concern. The much-dreaded National Security Agency (NSA) there is building a new massive data centre (euphemism for a spy centre) at Bluffdale (Utah). This $2-billion facility will be ready in September 2013. What will it do? None can be more authentic than Wired, a magazine that keeps tabs on all technological trends across the globe.

Talking of the Utah facility, Wired refers to it as a project of immense secrecy; it is the final piece in a complex puzzle assembled over the past decade. Its purpose: to intercept, decipher, analyse, and store vast swaths of the world's communications as they zap down from satellites and zip through the underground and undersea cables of international, foreign, and domestic networks. Can you visualise anything more awesome than this for the future of privacy? My only fear is that India should not mechanically follow suit and indulge in this extravagance. The U.S.' National Aeronautics and Space Administration is flush with funds after 9/11. But in using this up it has possibly cast aside all that is valuable to us as human beings. Privacy is synonymous with civilisation. If that is sacrificed, what else is there for us to live for?

Introspection time

The CPI(M) and the CPI reiterate the Left's relevance in the neoliberal age and outline their plans to build an alternative.

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WHEN the leading functionaries of the two mainstream Left parties of India the Communist Party of India and the Communist Party of India (Marxist) recently gathered for their triennial conclaves in Patna and Kozhikode, the central themes of their deliberations were introspection and rallying forces.

The reasons were obvious. Over the past three years, the two Left parties have been going through a trying period, especially in terms of their role in national politics. They had suffered repeated electoral reverses, first in the 2009 Lok Sabha elections and later in the Assembly elections in their strongholds of West Bengal and Kerala. The reverses had come after an all-time high representation in the 14th Lok Sabha (2004-09), when the Left had a significant influence over the decision-making process of the United Progressive Alliance (UPA) government.

CPI leader Gurudas Dasgupta summed up the situation when he said the Left was fighting with its back to the wall.

In the run-up to a triennial congress, the two parties had prepared months in advance detailed assessments of the contemporary political, ideological and organisational challenges faced by them and circulated it among their units across the country a practice that is unique to the Left parties. Many of the units suggested amendments to the circulated drafts.

In terms of detail, the CPI congress held in the last week of March took up for discussion three documents a political resolution, a political report, and a report on the party organisation. At a more fundamental level, the CPI initiated steps to update the party programme it had adopted in 1992 in Hyderabad. As part of this initiative, a committee has been set up under the leadership of veteran leader A.B. Bardhan. The committee will collect opinions from different State units and segments of the party and prepare a draft programme, which will be discussed at a special congress later. The CPI(M) had undertaken a similar exercise in 2000.

The documents under consideration at the Kozhikode congress of the CPI(M) in the first week of April were a political resolution, a resolution on some ideological issues and an organisational report. The political and organisational resolutions and reports pertain to the political perceptions of the party as well as the state of affairs in the organisation. The document on ideological issues circulated at the congress dealt essentially with the issue of the advancement of neoliberal policies across the world and how countries with socialist, and Left and democratic perspectives particularly a number of countries in Latin America have addressed it. It also sought to draw lessons from these experiences and evolve a functional strategy for the Indian Left.

Both congresses took into account points raised in the unit-level discussions across the country and incorporated amendments suggested by the units before finalising the political, ideological and organisational directions. Many observers surmised that the CPI(M) document on ideological issues was triggered by some initiatives of the party-led State governments, particularly the Left Front government in West Bengal, on the lines of economic liberalisation and their negative fallouts that had adversely affected the party. However, CPI(M) Polit Bureau member Sitaram Yechury told Frontline that there was no such connection.

Both congresses asserted that despite the electoral and other reverses suffered by the parties, the relevance of the Left and the role it had to play in upholding the interests of the people, particularly the working class and other marginalised sections of society, had only increased in the current national and international scenario. At the international level, the congresses pointed out, the capitalist world was facing its biggest crisis since the Great Depression of the 1930s, resulting in rising inequities and growing unemployment.

The parties also pointed out that the crisis was a direct outcome of the neoliberal capitalist trajectory taken by international finance capital and that the prolonged crisis pointed to the unsustainability of finance capital-driven globalisation. The congresses noted that there were growing protests worldwide against the neoliberal order and that more and more people were coming out against the threats to their livelihood and social welfare benefits.

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At the national level, the general line of the two parties was that in the past two decades, the Congress and the Bharatiya Janata Party (BJP), the two big mainstream parties, had implemented neoliberal policies in the garb of reforms' during their rule. The parties pointed out that this policy direction had plunged the country into an ever-deepening crisis. They also stated that the economic crisis heaped unbearable miseries on the people in the form of price rise, unemployment and economic disparities. This is further aggravated by corruption of unprecedented proportions. The congresses noted that these deviations in the system were threatening the economic sovereignty and independent foreign policy of the country.

Both parties called for the creation of a Left and democratic alternative with a clear emphasis on alternative policies to the neoliberal route taken by the Congress. CPI(M) general secretary Prakash Karat categorically stated that an alternative could not be built up merely on the basis of electoral alliances of non-Congress, non-BJP parties but on the basis of sustained mass struggles on a variety of issues. He told Frontline that the political resolution of the CPI(M) envisaged an electoral strategy that sought to isolate the communal BJP and defeat the neoliberal Congress, but the alliances formed for this would not automatically lead to a Left and democratic alternative.

S. Sudhakar Reddy, the newly elected general secretary of the CPI, pointed out that a committee was set up six months ago under the leadership of Telugu Desam Party chief N. Chandrababu Naidu to take up the cause of kisans (farmers). Besides the CPI, the CPI(M), the Revolutionary Socialist Party (RSP), and the Forward Bloc, the TDP, the Janata Dal (Secular) and Ajit Singh's Rashtriya Lok Dal were part of it. But Ajit Singh has since joined the government. We need more concrete commitment to agitational causes that is the emphasis of the Patna Congress, Sudhakar Reddy told Frontline.

At the CPI(M) congress, it was admitted that the party had failed to emphasise the difference between a Left and democratic alternative and a third front of non-Congress, non-BJP parties that had come up during the 2009 Lok Sabha elections. This Left and democratic alternative would come up only through sustained mass struggles, asserted Bardhan. Karat said an alternative would be created only by building a stronger CPI(M) and a stronger Left.

Issues identified

The issues broadly identified by the parties for widespread mass agitation include illegal and unfair acquisition of land for the benefit of corporate houses, loot of land and minerals by corporate houses and private parties in cahoots with several State governments and the Union government, privatisation of water resources and the undermining of the public distribution system (PDS).

The parties also decided to campaign more actively for fair land distribution among the landless and for the strengthening of universal health care and education. Protection of public sector units and championing the cause of a strong Lokpal are the other key areas of struggle they have identified.

At the CPI congress, it was repeatedly asserted that sporadic struggles on one or the other of these issues would not be sufficient to draw more and more democratic forces in the struggle for a programme-based alternative. Leaders like Gurudas Dasgupta called for sustained and militant campaigns away from the considerations of parliamentary politics, which, they said, would help alter the existing equations substantially and lead to a realignment of social forces.

These calls are significant in the context of several self-critical observations at the two conclaves. Addressing the media during the congress, Yechury pointed out that objective conditions to build up the Communist party and a stronger Left existed in India, but the movement needed to work harder to create the subjective conditions for this through purposeful agitations and mass actions. The political resolutions of the CPI and the CPI(M) reiterated this line.

The CPI(M) political resolution said: The specific issues of the Dalits, minorities, tribal people and women have to be taken up as part of the general democratic platform. Despite the emphasis given to develop sustained struggle on local issues in the last two party congresses, this has not been adequately done. This weakness should be rectified. The various issues of the people concerning their livelihood, land, job security, fair wages, access to health care, education and basic services, all of which are affected by the neoliberal polices, should be taken up for conducting sustained struggles locally and also to launch State-wide movements. Movements against the neoliberal policies should be launched at the all-India level and in the States.

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The CPI document said: Major tasks remain to streamline our own organisation from bottom to top by activating all units at all levels by rejuvenating it through the principle of change with continuity and induction of younger cadres in the leadership from all sections, particularly the downtrodden, Dalits, Adivasis, backward classes and minorities. Party must be made a party of all working people espousing the cause of socialism through the application of Marxism-Leninism in the concrete Indian condition.

Organisational changes

At the organisational level, both parties have taken recourse to some measures to advance short-, medium- and long-term objectives formulated at the triennial conclaves. In the words of Karat, the party's current organisational principle is continuity with change. In line with this, the CPI(M) amended its constitution, stipulating that party secretaries at various levels, including the general secretary, could have a maximum of three terms, where each term consists of three years or the period between two party conferences. A fourth term would be possible only if the outgoing secretary got the support of three-fourth members of the existing committee. Karat himself was elected for the third term.

The Polit Bureau, the party's highest day-to-day decision-making body, witnessed the induction of three relatively younger members Suryakant Mishra from West Bengal, A.K. Padmanabhan from Tamil Nadu and M.A. Baby from Kerala.

The CPI witnessed a generational change when Bardhan stepped down as general secretary and paved the way for Sudhakar Reddy.

Speaking at the CPI(M) congress as a fraternal delegate, Bardhan called for a national-level coordination committee to strengthen and concretise the association between the two parties further. He was of the view that this would improve coordination between the parties and contribute to a stronger Left in the country. While such mechanisms and a policy of not confining political and organisational initiatives to electoral politics may help the two parties, but, as pointed out by Yechury, the Left forces in the country could be strengthened only by creating the subjective conditions for a revolutionary change. And for that, the Left would have to live up to its promise to launch mass struggles in a sustained manner over a long period of time.

For a Left & democratic front of working people'

politics

THE 20th congress of the Communist Party of India (Marxist) in Kozhikode was an event keenly watched by many, coming as it did in the context of the recent electoral reverses suffered by the Left. This was an occasion for the CPI(M) to evaluate its current position and to formulate its tactics to take its objectives forward. In an interview to T.K. Rajalakshmi and Venkitesh Ramakrishnan, Prakash Karat, CPI(M) general secretary, spoke on ideological and other issues. Excerpts:

From Coimbatore to Kozhikode, what is the takeaway in political and organisational terms? What is the shift in the tactical line as compared to the 19th congress?

An important difference between the 19th party congress held in Coimbatore and the 20th congress in Kozhikode is that at the time of the 19th congress, we were still supporting the United Progressive Alliance government from outside. This changed subsequently when we withdrew support. In the 20th congress, we have worked out a political line of opposing the UPA government's economic policies and calling for a defeat of the Congress while continuing to work to isolate the BJP.

The 20th congress has recognised the seriousness and the various dimensions of the agrarian crisis. How does the CPI(M) intend to take up the land question to addressing this issue?

As far as the agrarian crisis is concerned, the effects of this crisis are borne mainly by the poor peasants, agricultural workers and the rural workforce. The 20th congress has focussed on the need to intensify the struggles of the small farmers and agrarian workers. There is also the farmers' fight against forcible land acquisition. The party will work with and mobilise farmers against such acquisitions. Further, the land reform agenda has to be brought back.

The aggressive expansion of imperialism and its influence on national policies were underscored in the congress. How does the CPI(M) intend to deal with this challenge?

Our party has been consistently opposing the growing influence of the United States. The UPA government has forged a strategic alliance with the U.S. This was the reason why we withdrew our support to the UPA government on the nuclear deal. In the party congress, we have decided to campaign and mobilise people against the growing military collaboration with the U.S. and oppose all the policies being adopted by the UPA government under U.S. pressure.

The congress has resolved to work for a Left and democratic alternative asserting that it would not be merely an electoral understanding with non-Congress, non-BJP parties. What exactly are the contours of this alternative? Would non-political organisations and parties that do not take part in electoral politics be part of this?

Our main goal is to build a Left and democratic front that can be the only real alternative to the present order. We have clarified that this is not some electoral alliance but a gathering of the working class, peasantry and other sections of the working people around a Left and democratic platform. Such an alliance will emerge only through prolonged struggles and movements. We are not envisaging such a Left and democratic front of parties alone but of various organisations of the working people.

The political resolution has given a call to isolate the BJP and defeat the Congress. But what would be the CPI(M)'s position if government formation is not possible without the participation or support of these two mainstream parties after the next general elections?

Yes, we will work for the defeat of the Congress and the BJP, but it is too early to say what will happen at the time of the Lok Sabha elections. Our main concern is to strengthen the CPI(M) and the Left's representation in Parliament. We would also like to see non-Congress, non-BJP forces do well.

The recent elections to State Assemblies have shown a political resurgence of regional parties which have alternately opposed and accepted policies of neoliberal-isation. Does the CPI(M) have plans to concretise their opposition to neoliberal policies and incorporate them into the alternative front?

The regional parties have a substantial mass base in the various States. We can cooperate with some of these parties on commonly agreed issues such as defence of federalism, secularism and taking up various people's issues. But it is also a fact that many of these parties accept the neoliberal policies. That is why we are not thinking of a programme-based alliance with these parties at present.

The CPI(M)'s own track record in handling neoliberalism while in government is considered by many as wanting, particularly in the context of the entry of the Salim group in West Bengal and the Nandigram incidents. In this context, should the new document on ideological issues be perceived as a result of the realisation that this engagement with liberalisation has resulted in mistakes?

The Left Front governments, whether in West Bengal, Kerala or Tripura, have sought to implement some alternative policies. But these are State governments, which have limited powers and resources in the existing state structure. The implementation of land reforms is itself a policy that is contrary to the neoliberal approach. Some political and administrative mistakes were made on the issue of land acquisition in West Bengal for industry. We have reviewed this matter in our party. The resolution on ideological issues adopted by the 20th congress will help to clarify further our understanding about imperialist globalisation and how we should tackle it. But we are clear that being in State governments, we cannot adopt the Left and democratic programme. That can be done only at the Central level.

The congress has once again reiterated that while objective conditions exist for building up a strong Communist party, subjective conditions have to be created through mass struggles. What are the key issues and plans identified by the congress in this direction?

There has been an exhaustive discussion on the struggles launched by the working class, peasantry, agricultural workers and other sections during the recent period. Unless we are able to develop struggles on local issues on a sustained basis and wider united struggles, we cannot link up with the people and influence them. Such struggles have been inadequate. Further, we need to consolidate after such struggles and movements. The February 28 strike by workers is a good example of a widespread united struggle. We have given a call for intensifying and widening such struggles.

The political resolution adopted at the extended Central Committee at Vijayawada said: Parliamentary democracy itself is getting corroded by neoliberalism and the impact of global finance capital. There are various manifestations of the subversion of democratic process. The experience of several parties, including electoral allies of the Left, underscores this assessment. How would a Left and democratic alternative be taken forward in this context?

There is a serious problem of big capital and money power in politics corroding the parliamentary democratic system itself. For the CPI(M) and the Left parties, the growing influence of money and the representatives of big business entering politics is a serious challenge.

The Left parties are sought to be marginalised in the electoral system by the use of such money power. That is why we are emphasising that the Left and democratic alliance is not geared to be an electoral arrangement. It is only by strengthening the Left and democratic movement that we can hope to counter the use of money power.

There is a stream of opinion that parties that advocate assertive politics of identity against centuries of caste oppression are natural allies of the Left. But the political resolution calls for a fight against identity politics. Isn't there a contradiction here?

The concept of identity politics is itself a regressive one. It seeks to mobilise people on narrow and perceived identities and separate them from the politics and movement of other oppressed sections. As against this divisive identity politics, what we are advocating is the fight against caste and social oppression. When we take up the issues of such oppressed sections, we are at the same time working for the unity of all oppressed sections, without which there can be no real social transformation. We are against identity politics and we are for the united fight against the oppression of people of various identities such as those based on caste.

The Coimbatore congress had laid emphasis on a rectification drive in the party. There is a criticism that this drive is very selective. There is also the view that the basic thrust of the rectification drive has gone against mass leaders who have consistently opposed neoliberal deviations. The difference in the manner in which V.S. Achuthanandan and Buddhadeb Bhattacharjee, former Chief Ministers of Kerala and West Bengal, have been dealt with is highlighted in this context. How would you respond to this?

The purpose of the rectification drive is to correct wrong trends such as parliamentarism, individualism, careerism and [to ensure] maintenance of Communist norms and standards. It has nothing to do with the election of our leading committees and the leadership. The considerations for those who have been taken into the Polit Bureau are the political and organisational requirements.

Semblance of justice

other

VERDICTS were delivered in April in two cases relating to the communal riots in Gujarat in 2002. A Special Court in Anand district convicted 23 persons for burning to death 23 people in a house in Ode near Anand. Eighteen of them were given life terms. However, in the second case, known as the Gulberg Society case, which relates to the killing of 69 people, the victims of the violence suffered a setback when the Supreme Court-appointed Special Investigation Team (SIT) filed a closure report in the court. The difference between the two cases is that Chief Minister Narendra Modi is accused number one in the latter, filed by Zakia Jafri, widow of former Member of Parliament Ehsan Jafri, who was one of the riot victims.

Does the closure report mean that it is curtains for the Zakia Jafri case and that Modi has finally got a clean chit? For the short term yes, say activists. Zakia Jafri will continue her battle for justice. The judicial process allows her to contest the closure report and take the case up to the Supreme Court.

There are nine cases relating to the riots that broke out in Gujarat after the Sabarmati Express carnage in Godhra on February 27, 2002. Most of them have reached the final stage, and verdicts will be delivered in the coming months. The first semblance of justice came last November in the Sardarpura massacre case in which 31 accused were given life terms for burning alive 33 Muslims.

Obviously, the verdicts do not bode well for the Chief Minister, when the State is heading for Assembly elections later this year. Besides, Modi has been using every opportunity to project himself as the next national leader from the beleaguered Bharatiya Janata Party (BJP). He has been trying hard to shake off the the-man-behind-the-riots label, but he has not been very lucky.

In the Gulberg Society case, Modi and 61 other top politicians, administrators and police officials are accused of being responsible for the attack on the colony.

While pronouncing the judgment, the Ahmedabad Metropolitan Magistrate said the SIT had not found any evidence to prosecute the Chief Minister, top bureaucrats and senior police officers and recommended that the investigation in the case be closed.

According to the SIT, no offence has been established against any of the persons listed in Ms. Jafri's complaint. Therefore, as per the Supreme Court's order and the principle of natural justice, the complainant has to be given a copy of the report and related documents, the court said.

A disappointed but determined Tanvir Jafri, son of Ehsan Jafri, told mediapersons: The SIT says there is no evidence against Mr Modi, but not the court. The SIT's decision is of no value if the magistrate decides against it. It may take time, but we are going to fight it out.

Activist Teesta Setalvad of the Citizens for Justice and Peace (CJP), who has stood by the Jafris in their legal battle, says the amicus curiae report is not out yet and that report will be crucial to the case.

The SIT chief, R.K. Raghavan, was measured in his response to the court order. The CJP and other activist organisations have repeatedly accused the SIT of not taking into account all the evidence presented. They charge that the probe was handled badly, and cite the fact that two officers, Geeta Johri and Shivananda Jha, were removed from the SIT for shoddy work.

Raghavan said that the SIT did a good job and that closure had been recommended in the Gulberg massacre case as the team could not find any evidence against the people named in the petition. He said: We have filed the report saying no evidence on the contents of a particular petition was available and recommended closure.

Ode to justice

Ode, a small town near Anand, witnessed the gruesome massacre on March 1, 2002. Many of the 23 people burnt alive in a house were women and children. The case was one part of the nine that the SIT probed.

On April 9 this year, the Ode case became the second in the nine to see justice delivered. The prosecution had demanded the death sentence for 18 of the 23 persons convicted for murder and criminal conspiracy. It is a heinous case involving mass killings of women and children, so the trial court should award capital punishment to the convicts, Special Public Prosecutor P.N. Parmar said. The trial, which began in November 2009, saw 158 witnesses being examined.

The Ode and Sardarpura cases raise the hope that the Gulberg case will also see justice eventually.

Anupama Katakam

Patent to plunder

AMIT SENGUPTA cover-story

India's efforts to produce and supply life-saving drugs at affordable prices face challenges from multinational companies trying to evergreen their patents.

THE average life expectancy across the globe has increased from around 30 years a century ago to over 65 years today. This has been made possible in large part by modern medicine. Never before in history have humans had access to such an array of medicines and devices to treat and ameliorate illness. These advances have also created a new terrain of conflict. While the knowledge required to promote health has expanded enormously, paradoxically, so have the attempts to restrict access to such knowledge.

The current regime of intellectual property rights (IPR) seeks to exercise monopoly control over the production and reproduction of knowledge. Consequently, products to treat a range of diseases are denied to those who need them the most merely because they cannot pay for them. It is denied to them not because these medicines cannot be produced at a reasonable cost but because a few corporations treat the knowledge as their property and sell these medicines at exorbitant prices. They also use the monopoly created by patents to prevent other companies from producing and selling these drugs at much lower prices.

Nothing illustrates this better than the impact of the human immunodeficiency virus/acquired immune deficiency syndrome epidemic in Africa. In 2001, the annual cost of treating one HIV/AIDS patient was $10,000. Some African countries would have had to spend more than half their gross domestic product to procure these medicines for those who needed them. The tragedy is that these medicines need not have been so expensive. In 2003, the Indian company Cipla finally started selling the same medicines at $250 per annum at 1/40th the earlier cost. Even this price was high, and the same drugs can be bought today at less than $100 for a year's supply.

Between 1972 and 2005, India had one of the most progressive patent laws in the world. It was precisely in this period that the domestic drug industry became a global force and is now the third largest (by volume) producer of drugs in the world. The signing in 1994 of the World Trade Agreement [Uruguay Round] which became the World Trade Organisation (WTO) in January 1995 marked India's accession to a global patent regime. India's earlier law, the Patents Act, 1970, worked on a very simple principle. It argued that patents (a monopoly over the manufacture and distribution of a product) would not be allowed in the two most vital areas of human existence food and health. New medicines could be manufactured by Indian companies without hindrance. This is why Cipla was able to manufacture and supply HIV/AIDS medicines at a fraction of the earlier prices. Much of this enabling environment for Indian companies changed when India amended its Patents Act in 2005 after completing the 10-year transition period allowed when India signed the WTO agreement.

However, Parliament, while amending the Patents Act to conform to the obligations set by the WTO agreement, introduced a number of health safeguards. These were designed to mitigate the impact of a patent regime that denied Indian companies free access to available knowledge. Two recent developments are now poised to test the ability of the domestic law on patents after the 2005 amendments to actually secure access to medicines.

The Indian law faces a challenge from the Swiss drug maker Novartis. At the heart of the challenge lies the vital anti-leukaemia (blood cancer) drug called imatinib mesylate. The drug was introduced in 2001 and has quickly become the key drug used to treat a form of leukaemia called chronic myeloid leukaemia (CML). For patients suffering from CML, the drug is the difference between a healthy life and a death sentence.

Imatinib mesylate has been patented in many countries by Novartis, which sells the drug under the brand name Glivec (or Gleevec). The patent application for Glivec was rejected in 2006 by the Indian patent office, which upheld the contention of Indian generic companies and of the Cancer Patients Aid Association (CPAA) that Glivec was not a new drug and did not merit grant of a patent.

Novartis persisted in its efforts and appealed to the Intellectual Property Appellate Board (IPAB). In June 2009, the IPAB upheld the decision of the patent office. Simultaneously, Novartis filed two writ petitions in the Madras High Court, one challenging the decision of the patent office and the other challenging Section 3(d) of the Patents Act. In the latter case, Novartis claimed that the section was in violation of India's obligations to the WTO. The Madras High Court rejected both these appeals. It pointed out that domestic courts could not be asked to give an opinion regarding international treaties and obligations and that Novartis should take its complaint to the disputes settlement mechanism in the WTO. Novartis has never done so, and clearly Section 3(d) does not violate international obligations.

It is important to understand why courts and the patent office have repeatedly turned down Novartis' request for a patent. The original patent on Glivec was filed by Novartis in 1993 for the amorphous molecule of the chemical imatinib mesylate. An amorphous salt is what exists in nature and is a mixture of different variants. In the late 1990s, Novartis filed a fresh patent for the beta variant of the molecule, which is already present in the amorphous salt patented earlier. It also claimed that the beta variety was better absorbed in the body and was more stable. The 1993 patent was not recognised in India as at that time Indian law did not allow the patenting of medicines.

When the law was changed in 2005, Novartis applied for a patent for the beta variety of the salt. The patent office refused a patent on a number of grounds. It said that under Section 3(d) a slightly modified version of a known molecule could not be patented. Section 3(d) stipulates that trivial changes in existing molecules cannot be candidates for fresh patenting. Such trivial patenting (known as evergreening) is an old ploy used by drug companies to extend their monopoly. Companies first apply for a patent for the basic molecule and then attempt to extend the life of their monopoly by applying for fresh patents after a few years on a slightly different version of the original molecule.

The patent office also said that the patent application did not fulfil two necessary criteria for patenting novelty (that is, it should be a new compound) and inventive step (that is, it should involve an inventive state that is not anticipated by someone well versed with the technology). Both the patent office and the IPAB invoked Section 3(d) to deny Novartis' appeal.

Novartis is now arguing its case in the Supreme Court through a special leave petition challenging the IPAB's interpretation and application of Section 3(d) to its patent application, and final arguments on the case are to commence on July 10, 2012. Instead of challenging Section 3(d), Novartis now argues that the section has not been properly interpreted. The section says that minor variations in an existing molecule cannot be patented unless there is a significant enhancement in the efficacy of the medicine. Now Novartis claims that since the beta variant is better absorbed (by about 30 per cent) it constitutes a significant enhancement. Novartis' panel of expensive lawyers is led by Gopal Subramaniam, who was the Solicitor General of India (and hence technically responsible for leading the government's defence) when Novartis first approached the Supreme Court.

Claims of altruism

How much would Novartis gain if its patent were to be upheld? The arithmetic speaks for itself. A month's supply of Glivec costs Rs.1,20,000 way beyond the means of more than 99 per cent of Indians. Remember that the drug has to be taken lifelong. Yet the same drug is sold by several Indian companies at Rs.8,000 for a month's supply 1/15th of what Novartis charges. At the heart of Novartis' battle is a $4-billion-plus global market for Glivec about Rs.20,000 crore, which is equal to the entire Union health budget of India for 2010-11.

Novartis claims that price is not an issue in India because eligible patients are covered by a programme called GIPAP Glivec International Patient Assistance Programme. The only problem with Novartis' spin on the issue is wrong arithmetic. Novartis claims that it supplies the drug free of cost to about 11,000 leukaemia patients in India. The CPAA estimates that there are over 100,000 patients in India who suffer from CML and that 20,000-odd new patients are added every year (the disease has an annual incidence of 1-2/100,000 population a year). Studies also show that the disease strikes earlier in life in India in a younger age group than in Europe and North America.

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Novartis has regularly claimed credit for its GIPAP programme. How altruistic is the GIPAP programme? The programme was launched in 2002, and Novartis claims that it reaches 35,000 patients in 80 countries. In 2003, The New York Times carried an investigative report that blew the lid off the claims of altruism. The report (as well as another report from Argentina) documents how GIPAP has been used by Novartis to first create a demand for Glivec and then to pressure governments and health management organisations to reimburse its cost. The report stated: In wealthier countries like South Korea, Hong Kong and New Zealand, Novartis, meanwhile, has encouraged patients who have received free drugs to become advocates, pressing public health systems to pay high prices for the drug. One company document declared that drug donations along with media campaigns and legal tactics were part of a concerted plan to win reimbursement for Glivec.

Novartis says that it is not fighting the case to make money but to uphold the principle that it deserves credit for the investment it made in research to develop the drug. What Novartis does not tell us is that Glivec was granted orphan drug status in the U.S. and was therefore eligible for tax rebates equal to half the cost of clinical testing (the major cost of drug development).

Brian Druker, one of the scientists involved in developing imatinib while working in Oregon Health and Science University Knight Cancer Institute, commented in a signed article in Livemint in 2007: My work in Oregon on a therapy for CML was primarily funded by public sources, particularly the National Cancer Institute. My persistence with scientists at Ciba-Geigy (now Novartis) helped to keep the development of imatinib on their agenda despite uncertainty from product managers. As imatinib progressed through early and late clinical trials and demonstrated outstanding results, scientific and media interest in our discovery increased. The approval of imatinib by the FDA [the U.S. Food and Drug Administration] in May 2001 for use in CML was the culmination of a 10-year project for me, something I had dreamed of since medical school. And yet, Novartis laments that it is not being given due credit for its original research.

India breaks a patent

In March 2012, the Indian patent office issued a compulsory licence (CL) to the Indian generic drug company Natco Pharma Ltd for Bayer's anti-cancer drug sorafenib. The licence was issued under Section 84 of the Patents Act. It breaks Bayer's monopoly over the drug, and Natco can now manufacture and sell the drug in India.

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Sorafenib has been shown to extend survival rates among those suffering from hepatocellular carcinoma (liver cancer) and renal cell carcinoma (a form of kidney cancer). At present, Bayer's version of the drug costs Rs.2,80,000 a patient a month. Natco will make the drug available at a cost of Rs.8,800 a month, a 97 per cent reduction on Bayer's price.

The decision has been followed by reverberations across the world. A range of people working on public health and access to medicines issues have welcomed the decision of the Indian patent office. The fact that this is the first CL issued in India is in itself a major step and can be a precedent for many more CLs in the future.

The CL on sorafenib not only helps cancer patients who require the drug but is also a step towards building domestic manufacturing capacity and knowhow in a new range of anti-cancer drugs. Sorafenib is one of the first in a group of new drugs that specifically target cancer cells. Similar drugs with better results are likely to be available over time, and it is important that generic manufacturers develop capacity to manufacture these.

Patents are supposed to represent a balance between the rights and obligations of a patent holder. Patent laws are required to ensure that the products of new research are available to the largest number of people, while providing a fair return to the innovator. Compulsory licensing is a key instrument incorporated in patent laws to maintain this balance. It allows regulators to break the monopoly of a patent holder by allowing a third party to use the patent in situations where the patent holder abuses the monopoly right to deny access to its innovation to a very large number of people.

The 2005 Patents Act provided broad grounds for issuing a CL, including (a) the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) it is not available to the public at a reasonably affordable price, or (c) the patent is not being worked. By pricing its drug at almost Rs.3 lakh for a month's treatment, Bayer was denying access to the drug to thousands of cancer patients in the country.

Decisive battle?

The two developments have several long-term implications for India's domestic drug industry. Novartis is challenging the very heart of the Indian Patents Act and its attempt to balance the rights of patent holders with the needs of the Indian people for access to treatment that is affordable. Section 3(d) of the Act has been used several times by the Indian patent office to deny patents for other similar trivial inventions, especially in the case of HIV/AIDS medicines. If the section is diluted or overturned, all these cases will be reopened. Not just that, it will open the door for a flood of applications, many of which were not filed by companies because of the existence of Section 3(d).

The case has implications not just for leukaemia patients but for a whole range of patients who are today able to access cheaper drugs made by Indian companies. These patients are located not just in India but in over a hundred countries in Asia, Latin America and Africa. For example, over 80 per cent of all patients in developing countries who consume HIV/AIDS medicines are able to do so because Indian companies supply them these medicines at affordable rates. This is a case that Novartis must not win because it is not about corporate pride. It is a case that sets corporate greed against the lives of millions across the world.

It is useful to recall that the Madras High Court, while rejecting Novartis' appeal, had said: We have borne in mind the object which the Amending Act wanted to achieve, namely, to prevent evergreening; to provide easy access to the citizens of this country to life-saving drugs and to discharge their constitutional obligation of providing good health care to its citizens.

The first grant of a CL in India has clear implications for the availability of new drugs at affordable costs, not just in India but in many developing countries. Compulsory licence provisions exist in the laws of most countries, but they are rarely used. As a result, only a few countries have issued CLs since 1995. Most of these have been for HIV/AIDS medicines and almost all have been for use by the government or in situations where a government has declared a national emergency (as in the case of the HIV/AIDS epidemics in Africa). The U.S. and the European Union, acting at the behest of their pharmaceutical industries, have brought extreme pressure to bear upon developing country governments to dissuade them from issuing CLs.

What is extremely significant in the case of the sorafenib CL in India is that it is a rare instance when a general CL has been issued, not bound by government use provisions or provisions allowed only in cases of extreme urgency or national emergency. This has the potential to expand the scope of CLs vastly, in terms of both the kind of drugs for which they can be issued in the future and the conditions under which they are issued.

Further developments in both these areas will be closely watched as they will determine whether India can continue to be known as the pharmacy of the South with the ability to produce and market new drugs at prices people in most countries in the developing world can afford. We may well be watching the decisive battle against patent monopolies that have, for too long, erased the benefits of scientific advances in health care across the world.

Dr Amit Sengupta is with the All India Peoples Science Network and the Jan Swasthya Abhiyan.

Section 3(d)

cover-story

Section 3 of the Indian Patents Act, 1970, lists what are not inventions. The relevant subsection (d) after it was amended in 2005 reads:

the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Before 2005, subsection (d) read thus:

the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.

A big step forward

C.P. CHANDRASEKHAR cover-story

That this is the first time a compulsory licence has been granted in India is in itself important.

INDIA'S long struggle to ensure access to affordable medicines for its people recently took a positive and interesting turn. In early March, just before he demitted office, Controller General of Patents P.H. Kurian passed an order on an application filed by Natco Pharma, headquartered in Hyderabad, requesting a licence to produce an anti-cancer drug (sorafenib tosylate), the patent for which is held by the German pharmaceuticals and chemicals giant Bayer. It produces and markets the drug under the brand name Nexavar, which is used in the treatment of patients diagnosed as being in the advanced stages of affliction with liver or kidney cancer. Having failed to obtain a voluntary licence for manufacture from Bayer, Natco had filed an application under Section 84 of the Indian Patents Act, which specifies the conditions under which a compulsory licence (CL) may be issued to a producer other than the patentee. Compulsory licensing involves providing an agent, other than the holder of the patent for a product or process, permission to produce or market that product without the consent of the patent holder.

Before 2005, when India amended its Patents Act to recognise product patents, Natco or any other Indian pharmaceutical company would not have needed such permission. All it needed to do was demonstrate that it had access to a process technology different from that used by Bayer to produce sorafenib. This encouraged the growth of an industry producing a large number of on-patent (and off-patent) drugs and marketing them at prices much lower than those charged by the original patentees. The net result was the well-documented fact that drug prices in India were among the lowest in the world and there was no shortage of essential drugs in the country.

However, once India signed into the Uruguay Round Agreement, which included an agreement on Intellectual Property Rights (IPR), India's Patent Act, 1970, had to be amended thrice, in 1999, 2002 and 2005, to bring it in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). These changes not only replaced the chapter on CLs but culminated in the recognition of product patents. Inasmuch as the latter prevented Indian firms from producing a patented product (unless the technology was voluntarily licensed by the patent holder) and gave the patent holder a monopoly right to produce the product, there was a danger that prices of medicines would rule high and attempts to regulate or control them could lead to inadequate availability of medicines.

The TRIPS Agreement was to the disadvantage of less-industrialised developing countries like India, which had registered few patents, including in a crucial area like pharmaceuticals. However, the TRIPs Agreement did provide a few windows of opportunity for governments to intervene to rein in prices in support of needy patients in their countries. Crucial among them was the right (subject to conditions) that the agreement granted governments to resort to compulsory licensing on grounds such as the public interest, anti-competitive conduct, or need for non-commercial government use. It was that right that the clauses on CL in the revised Patent Act sought to interpret.

What constitutes public interest is an issue of significance . In principle, the right of the government to resort to compulsory licensing can be invoked when the patent holder does not work the patent or does so in a manner that is inimical to the public interest, leading to unreasonable prices, inadequate technological progress, or inability to deal with public health or other emergencies. However, the TRIPSAgreement did require that the patentee should be notified about possible violations and the prospect of issue of a CL and that negotiations should be held with the patentee to resolve the issue if possible.

In the case of pharmaceuticals, this right to issue a CL was strengthened under pressure from developing countries and civil society activists in the Doha Ministerial Declaration of 2001. The Declaration on the TRIPS Agreement and Public Health of 2001 affirmed the power of WTO members to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted and held that the agreement can and should be interpreted and implemented in a manner supportive of WTO Members' rights to protect public health and, in particular, to promote access to medicines for all.

In India these flexibilities became a matter for debate before the revision of the Patents Act was legislated to make it TRIPS-compliant, leading to major advances. One of those advances is the stipulation that a CL can be invoked also in instances where not only the patented product is not reasonably priced (say, relative to costs) but also the price is not reasonably affordable. Section 84 of the Indian Patents Act says: At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely: (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.

What was unclear was how the presence or absence of such grounds for action were to be assessed. Remarkably, after India amended its Patents Act to make it TRIPS compliant and recognise product patents, the government had not, until now, exercised the right to compulsory licensing even once, which would have helped clarify matters. This is despite the fact that in a crucial public health-related area such as drugs and pharmaceuticals the transition to the new regime made a considerable difference to both availability and affordability.

Being the first in itself makes the Nexavar judgment historic. But there is more to the judgment than its pioneering character. It is the grounds on which the Controller of Patents accepted Natco's application and rejected Bayer's opposition that are also path-breaking. One important ground was the assessment whether reasonable public requirement was being met with regard to the supply of Nexavar through importation. Noting that: (i) over the years, Bayer had imported the drug in volumes that could have treated only a small fraction (a little above 2 per cent) of those who could be credibly assessed as requiring the drug; (ii) that there were years in which no imports were made; and, (iii) that the company was relying only on the import route and not on local production to work the patent, the Controller General concluded that in a physical sense Bayer was not working the patent. It was not meeting the condition that the reasonable requirements of the public with respect to the patented invention were being satisfied.

He also rejected the argument that these circumstances with respect to supply of Nexavar had to be judged in the context of the fact that Cipla, another domestic generic pharmaceuticals manufacturer, has without licence been marketing sorafenib in India at a price much lower than that charged by Bayer. Bayer has filed an infringement suit against Cipla, which is pending in the courts. In the circumstances, the Controller General argued that this could not be an excuse for Bayer not ensuring adequate supply of Nexavar.

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A second important conclusion of the Controller is that the failure to meet demand adequately was partly caused by the high price of the product, which made it unaffordable. While Natco's counsel referred to research findings on reasonable estimates of R&D costs and the per capita incomes of the poor in India to argue that the product was unreasonably priced, the judgment itself focussed on the issue of unaffordability. Even when assessing this, the fundamental issue was not the fact that Nexavar was being priced at around Rs.2.8 lakh for a month's dosage of 120 tablets, when Cipla was supplying the drug at Rs.30,000 for a month's treatment, and Natco was promising the same quantum at Rs.8,800 if granted a licence.

Rather, starting from the fact that the sale of Nexavar over the previous four years was only equivalent to a fraction of the public's estimated requirement of this life-extending treatment, Controller General Kurian concluded that the drug was not bought by the public due to only one reason, that is, its price was not reasonably affordable to them. This is an important precedent, since it lays down a condition for assessing affordability. If enough of a patented drug that is crucial for the public is not being actually consumed, it must reflect the fact that a significant share of patients are not able to afford the drug at the price at which it can be sold. That does warrant invoking the right to issue a CL.

Finally, the judgment examined the issue of whether the patent was being fully worked in India, given that it was only being imported and not manufactured in the country. Counsel for Bayer referred to the fact that the phrase manufactured in India was dropped from the Patents Act when it was amended in 2002, to argue that local manufacture was not required to establish working of a patent.

Moreover, Bayer's counsel argued, cost-effective scales of production of the drug were far above India's requirement. This precluded local manufacture, in which quality control was also difficult to ensure. Not accepting this argument but recognising that the Act does not define the phrase worked in the territory of India, the judgment turned to international conventions and the fact that the issue of local manufacture though removed from one context when the Indian Patents Act was amended was incorporated in another clause (Section 84(1)(c)).

There are three points the judgment makes here. The first is that while importation rather than local manufacture is not a ground for forfeiture of a patent, a country may use the discretionary powers it has when framing patent legislation to make it a ground for invoking the right to compulsory licensing. Second, the understanding of working the patent in the relevant conventions does not imply working the patent on a commercial scale. And, finally but most importantly, mere importation cannot amount to working of a patented innovation.

According to the judgment, a patentee is obliged to contribute to the transfer and dissemination of the technology, nationally and internationally, so as to balance rights with obligations. A patentee can achieve this by either manufacturing the product in India or by granting a licence to any other person for manufacturing in India. This conclusion, if sustained, is also a precedent with implications that go far beyond this case and product.

On these grounds the Controller of Patents issued an order giving Natco the right to manufacture and sell a generic version of sorafenib tosylate, subject to pricing it at Rs.8,800 for a monthly dose of 120 tablets and the payment of 6 per cent royalty on the net sales to Bayer.

As noted earlier, this judgment does mark a whole new phase in India's journey to fashion a patenting regime that would make medicines affordable to the common man. It is bound to be a precedent that will be quoted in a range of other cases and products. This is not because this is the first instance of grant of a CL, which itself is important. The failure to resort to compulsory licensing thus far was not because of lack of global precedent. In fact, developed countries such as Canada, the United Kingdom and Italy and developing countries such as Brazil, Thailand, Malaysia, South Africa and Kenya have resorted to such licensing in the case of drugs and pharmaceuticals. Very clearly, ideology and international pressure had held back the system.

Controller General Kurian has initiated the process through which India can free itself of such fears and exercise its legitimate rights and options. The nation owes him much.

Patents and the law

V. VENKATESAN cover-story

The implementation of Patents Act, as last amended in 2005, raises significant issues of immediate concern to patients across the world.

INDIA'S Patents Act has an interesting history. Enacted first in 1911 as the Indian Patents and Designs Act in the colonial era, it primarily addressed the interests of inventors, who did not want their inventions infringed upon by anyone who copied them or adopted the methods used to make them. Independence in 1947 evoked new concerns about the Patents Act which were not anticipated in 1911. One of the realisations was that the old Act did not adequately take into account the substantial changes in the political and economic conditions of the country over the decades. These changes necessitated that patent rights were not enforced to the detriment of the consumer or to the prejudice of trade or industrial development of the country.

Although efforts to reform the Act began immediately after Independence, they bore fruit only in 1970, with the enactment of the comprehensive new Patents Act replacing the 1911 law. The Act has been amended five times and the last three amendments (1999, 2002 and 2005) are significant: they were necessitated by India's membership of the World Trade Organisation (WTO) and the resultant compulsion to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). TRIPS requires that a 20-year patent protection be available for all inventions, whether of products or processes, in almost all fields of technology. The unamended 1970 Act ensured only process patent for food items and medicines. This meant that non-inventors could make these products by a different process and maintain a steady supply in the market.

India had to amend its Patents Act to recognise product patent in the case of pharmaceuticals. This meant that manufacturers of medicines could secure monopoly rights over their products and increase their prices arbitrarily. However, both TRIPS and the 2001 Doha Declaration on the TRIPS Agreement and Public Health recognised the need for certain flexibilities within the Patents Act to cater to the interests of poor patients who could not afford the high cost of pharmaceutical products. India also had the advantage of a longer transition period (10 years from 1995 when India acceded to the WTO) before introducing product patents from January 1, 2005.

But this advantage came with an obligation to introduce three crucial amendments to the Patents Act. First, India had to permit product patent applications to be filed from January 1, 1995 (called the mailbox provision). Thus, if a product figuring in these applications was granted a patent in any of the WTO-member countries and the product had obtained marketing approval in those countries, then India had to grant five years of exclusive marketing rights (EMRs) before it granted or rejected the patent on the product.

The second set of amendments included redefining what is patentable, extension of the term of patent protection to 20 years and amending the compulsory licensing system, which was notified in 2002.

The third amendment introduced a product patent regime from January 1, 2005, in areas, including pharmaceuticals, which were earlier governed by process patents. Provisions relating to opposition to the grant of patents also formed part of the third amendment. Post-2005 is the story of how India has been balancing the need to strengthen the rights of patent holders with the duty to effectively address public interest concerns. A serious concern is how to ensure access to medicines at affordable prices by enforcing adequate safeguards in the implementation of the Act.

One such safeguard is Section 3(d) of the Patents Act, explaining what is not an invention, and therefore, non-patentable. This provision was substituted through the 2005 amendment.

Section 3(d) says, The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in the new product or employs at least one new reactant.

The Explanation to this provision says: For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy.

Section 3(d) aims to prevent evergreening. According to Shan Kohli, a blogger at spicyipindia.blogspot.in (posted on November 2, 2011), it states that only those pharmaceutical derivatives that demonstrate significantly enhanced efficacy are patentable. But this provision has been subjected to serious challenge by patentees and defended by those who oppose grant of patents on ineligible grounds.

Barring a Madras High Court decision in the Novartis case, which attempted to interpret Section 3(d) in the context of a constitutional challenge, there has been no case interpreting the scope and ambit of Section 3(d). According to intellectual property law expert Shamnad Basheer (see interview), the Supreme Court lost a fabulous opportunity to do so in Roche vs Cipla, and it is now hoped that we shall have some clear standards emerging from the Supreme Court in the Novartis-Glivec matter.

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Roche, a multinational drug manufacturer, first dragged Cipla, a generic drug manufacturer, to the Delhi High Court alleging that Cipla had infringed upon its patent rights for Tarceva, an anti-cancer drug. Justice Ravindra Bhat of the High Court refused to injunct the defendant Cipla on the grounds that the company supplied drugs at affordable prices and therefore granting injunction was against the public interest.

Roche then appealed to the Division Bench of the High Court, whose order proved only much more detrimental to Roche. On April 24, 2009, the Bench, comprising Justices A.P. Shah and S. Muralidhar, rejected the appeal and imposed costs of Rs.5 lakh on Roche. It also ruled that the patent in question did not seem to be implicated by Cipla's generic product. In any case, Roche's patent was susceptible to a serious validity attack. Roche then appealed against the Division Bench order in the Supreme Court. But the Supreme Court refused to examine the issue as the challenge to Roche's patent had proceeded to trial on final merits. The Supreme Court did not want to delay the trial.

Whatever the result of the challenge to Roche's patent, it is clear that Section 3(d) has been critical in filtering out frivolous patent claims. However, for this to become successful, it is important that generic manufacturers use other provisions, namely, the pre- and post-grant opposition to the grant of patents effectively.

A study carried out by Shamnad Basheer and his research associate, Souvik Guha, in September 2009, found the following:

The total number of pharmaceutical applications filed between 2005 and 2008 were around 9,719. The number of pharmaceutical patents granted during the above time frame was around 2,734. Of the 9,719 pharma applications filed, only 34 were challenged an abysmal 0.3 per cent.

Out of the 34 challenges, one was a post-grant opposition (in favour of Roche covering Pegasus) and the remaining 33 were pre-grant challenges.

Twenty-five of the 34 oppositions resulted in rejections, that is a significantly high ratio of 73.5 per cent. The patent applicant won in only nine cases. Twenty out of the 25 rejections were on the basis of Section 3(d). In other words, 80 per cent of the rejections were made invoking Section 3(d), indicating the efficacy of this controversial section.

According to Shamnad Basheer, the generic industry and public health groups are still coming to grips with this powerful mechanism and are taking some time to leverage it. Patent offices, even in the United States and in the European Union where the offices are better staffed than in India, are fallible. Therefore, he says, they must come forward and leverage the opposition mechanism to help the Indian patent office make the right decision, granting patents to only meritorious inventions. Perhaps the government ought to set up a committee to study the opposition mechanism and why it has been underutilised. It ought to undertake more awareness drives around patents and the opposition mechanism and provide logistical support, where possible, particularly to non-profit non-governmental organisations, he suggests.

A report in the Mint newspaper has suggested that most of the 25 patent applications rejected under the pre- and post-grant opposition category were made by foreign drug makers, including Novartis AG, Pfizer Inc., Gilead Sciences Inc. and AstraZeneca SA. Most of the oppositions were filed by Indian drug makers such as Cipla Ltd, Ranbaxy Laboratories Ltd, Sun Pharmaceutical Industries Ltd, and Torrent Pharma Ltd. Other challenges came from non-profit patient groups such Cancer Patients Aid Association, Sankalp and Positive People Living with HIV/AIDS.

According to D.G. Shah, secretary general of the Indian Pharmaceutical Alliance, Shamnad Basheer's study reveals that there are alarming numbers of frivolous patents being claimed in the country. The rate of rejections is very high corresponding to the number of oppositions. Shah said it could be because of poor understanding of these provisions by local companies and patient groups.

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A pre-grant opposition allows one to oppose patent applications filed by an applicant. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. India is the only country which provides for both pre- and post-grant opposition in its patent legislation. By doing so, India put the patent applicant in a disadvantageous position as the entire procedure for opposition to the grant of patents can be brought before the courts. It is, therefore, unfortunate that the stakeholders have not used these provisions to the fullest extent.

The patent office in Chennai had earlier rejected Novartis' patent on the anti-cancer drug, Glivec, following opposition from organisations representing cancer patients, among others. In another case, the patent office rejected Gilead's application for patent for its drug tenofovir in September 2009. It accepted the argument that Section 3(d), which states that patents should not be granted for known substances (including the salts of the known substance) that do not show improved efficacy, should block Gilead's application.

The Brazilian Interdisciplinary AIDS Association (ABIA) and the New Delhi-based SAHARA Centre for Residential Care and Rehabilitation together filed pre-grant oppositions because a patent in India would have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug. In 2008, the Brazilian government declared tenofovir to be of public interest in treating people living with HIV. On June 30, 2009, the Brazilian patent office issued a final refusal of Gilead's patent application for tenofovir disoproxil fumarate (TDF). Brazil will not be able to procure generic versions from India if tenofovir gets a patent in India. On the other hand, if the patent is rejected, Indian generic companies will be able to supply tenofovir to Brazil and other middle-income countries.

Gilead appealed against the patent office's rejection in the Intellectual Property Appellate Board (IPAB). While the appeal was pending, U.S. Commerce Secretary Gary Locke requested his Indian counterpart, Anand Sharma, a few days before President Barack Obama's visit to India in November 2010, that Gilead's challenge to the rejection of its patent covering Viread (Gilead's brand name for tenofovir) receive fair consideration. Observers reacted strongly to this, saying that any country, including the U.S., would have raised an objection had the Government of India taken up such corporate issues with its judicial mechanism. They felt India should have discarded the U.S. plea immediately, saying that the patent tribunal here was strong enough to decide such matters independently.

The U.S. intervention also raises the question whether the IPAB, a specialised IP tribunal tasked with dealing with certain kinds of IP disputes, is truly independent. It effectively replaced the functions of the High Court, insofar as a large range of IP disputes were concerned. At the height of the controversy, SpicyIP blog asked: Is IPAB seen as just another wing of the executive and not as an independent tribunal functioning as an organ of the judiciary?

A welcome first

T.K. RAJALAKSHMI cover-story

Industry reacts with caution to the grant of a compulsory licence to Natco, but cancer patients welcome it and hope for many more.

THE first compulsory licence (CL) issued by the Indian patent office, to the local drug manufacturer Natco Pharma Ltd to sell the generic version of Bayer AG's anti-cancer drug Nexavar, has led to varied reactions. The landmark decision has also raised concerns about the outcome of cases of a similar nature pending in court. The decision also assumes importance in the context of the government's plan to deliver universal health care as recommended by the high-level expert group appointed by the Planning Commission. Incidentally, the generic form of the drug is still expensive for many, at Rs.8,800 for a month.

While the pharmaceutical industry has reacted to the decision with overarching caution and disappointment, cancer patients have welcomed it and are hopeful of many more similar decisions. The Organisation of Pharmaceutical Producers of India (OPPI), a platform largely of foreign companies, expressed disappointment with the judgment. In a statement, Ranjit Shahani, OPPI president and head of Novartis India, held that compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. If used arbitrarily, compulsory licences will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient, he said. His argument is that for better access, improved health-care infrastructure and distribution are needed. Pharmaceutical companies have argued that they can have a system of differential pricing for different countries.

According to S. Srinivasan of the Vadodara-based organisation LOCOST (Low Cost Standard Therapeutics), differential pricing has never worked. It depends on the market which is the beneficiary and whether there won't be reverse leakages in the market. It also has a bit of elimination of manipulation of the market without market forces coming into play fully, and [it] can also be an argument against compulsory licences and local development of technology and backward integration. It is a bit like voluntary licensing of, say, Tenofovir without even benefits of any semblance of local manufacturing, such as it is with a voluntary licence. Generally, it is a device to hold a market captive and dependent on one manufacturer, usually the innovator. More importantly, it inhibits any questioning of pricing and costing per se of the product, investing the manufacturer with an undeserved halo, he told Frontline.

The basic issue is that these drugs are priced completely out of reach for the poor person, said a cancer patient who is on Glivec, which he accesses free at a leading government hospital in Delhi. He toldFrontline on condition of anonymity that the outpatient ward of the hospital was crowded with blood cancer patients. The medicine was being given free under the Access Programme of the company. In that particular hospital, there were three OPD sessions in a week, with each session being attended by nearly 125 patients, he said. The bulk of the patients came from the rural hinterland and there were very few patients from the middle classes, he added.

This is what happens just in one hospital. One can only imagine the number of needy patients, he said. He said that if he bought it from the open market, it would cost him Rs.1.5-2 lakh a month. The only reason I am able to use the drug is that even as exclusive marketing rights were given to the company, the condition was that it would provide the drug to needy people. In the case of this drug, the court held that under the Indian patent law generic production was permissible and rejected the patent on the drug. The company has challenged this in the Supreme Court.

He said that even for the needy persons, proof of income was demanded by the company. I am an income-tax payer and I legitimately file my tax returns. I passed the criteria to get the medicines free, he said. The government, he added, had taken a proactive line after the Left parties pressured the government to make several changes to the Indian Patents Act in 2005. The Left parties proposed as many as 13 amendments to the draft Patent (Third) Amendment Bill, 11 of which were passed by Parliament, he said.

As one who has been on the drug for nearly six years, he said he had to buy it from the market for the first four months. He said: I used to pay Rs.14,500 then, which was roughly equivalent to my monthly salary. Then I applied for the scheme and my application was sent back to the parent company. I have learnt now that the company has circulated a letter to all its patients stating that from 2012 onwards all new patients will have to pay Rs.10,000 a year and that they will not be able to provide the medicine free any longer. I cannot say I am out of the woods, but without this drug I wouldn't be talking to you today.

The Indian Drug Manufacturers' Association (IDMA), too, has welcomed the compulsory licence awarded to Natco. Gajanan Wakankar, executive director of the IDMA, said it was a very good step for cancer patients and for the government, which appeared committed to providing access to medicines. Between profit and profiteering, there is a very thin line. In this particular case, involving Bayer, it was not a case of reasonable profits, he said.

Compulsory licensing, he said, was a provision accepted under TRIPS [Trade-Related Aspects of Intellectual Property Rights] and was applicable all over the world, including the United States. The prime reason was to prevent the abuse of monopolies. Multinational firms should recover their costs incurred in research and development, but when the costs exceeded by a wide margin it was tantamount to profiteering, he said. The decision of the patent office seemed to have had a positive effect, he added.

On the issue of differential pricing by pharma companies, Gajanan Wakankar said there were ways to do it under the voluntary licensing system, but most companies were not doing it. He gave the example of the anthrax scare in the U.S., where the government threatened to issue a compulsory licence for the cure, and thereby ensured a reduction in the price.

He said Natco, which happens to be one of the IDMA's oldest members, had wanted a voluntary licence from Bayer for the drug but the latter refused. He explained that drug production even under compulsory licensing was difficult for ordinary companies because they had to employ highly qualified scientists who had the expertise and know-how to produce the same. The IDMA was largely responsible for pushing and drafting the Patents (Amendment) Act, 2005. There will be litigation but we hope that the law stands the test, he said.

Loon Gangte, representative of the Delhi Network of Positive (HIV) People, also welcomed the patent office's order, terming it a beautiful precedent. He said all third-line and second-line HIV drugs were patented. While the government had started rolling out second-line drugs, it was a matter of time before resistance would develop and third-line treatment would be required, he said. He said that while the government was being proactive, it was also a fact that there was not a single HIV drug that was not patented.

Western warnings

R. RAMACHANDRAN cover-story

India is coming under increasing pressure from the U.S. and the European Union for the strict patentability criteria it applies for medicines.

AS was only to be expected, the two landmark decisions made by the Indian patent office in recent times concerning pharmaceutical patent cases have not gone down well with the multinational drug industry. First, there was the rejection in 2006 of the patent application by the Swiss multinational Novartis for imatinib mesylate (sold under the brand name of Glivec, or Gleevec), its incrementally modified drug for leukaemia, or blood cancer. Then, on March 12, 2012, the Indian generic drug company Natco Pharma Ltd was granted a manufacturing licence to produce a generic version of the patented liver and kidney cancer drug sorafenib tosylate of the German multinational company (MNC) Bayer (brand name Nexavar) through the first-ever invocation of the compulsory licence (CL) provision in the Indian Patents Act, 1970 (as amended in 2005). The CL was granted to ensure affordability of the drug to Indian cancer patients. Natco will now produce the drug at a price that will be 97 per cent lower than Bayer's even after paying 6 per cent royalty on net sales to Bayer.

Bayer will most likely appeal against the order. Novartis challenged the patent office's rejection of its patent application first at the Intellectual Property Appellate Board (IPAB) and subsequently in the Madras High Court. Both upheld the Patent Controller's decision and rejected Novartis' appeals against the Indian government. Now the company has appealed to the Supreme Court. The first hearing is slated for July 10. These two cases have demonstrated how flexibilities available in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement (for patent protection) of the World Trade Organisation (WTO) can be successfully used to serve public health interests in developing countries over the interests of the private monopoly of profit-driven drug MNCs. The flexibilities in the TRIPS Agreement allow governments to decide what type of innovation is patentable. The criteria of novelty, inventive step, and industrial applicability are not defined in the agreement and are left for individual governments to determine within existing national legislation and circumstances. These are also, therefore, test cases for the Indian judiciary, and if these orders can be sustained in the face of imminent legal battles, they will serve as important precedents for exploiting the full power of the Indian Patents Act, while conforming to the WTO's intellectual property rights (IPR) regime, to ensure the Indian public access to health care it can afford.

Drug majors around the world, American companies in particular, which have, of course, been watching the Novartis case anxiously for the past five years, have been further jolted by the latest decision on Nexavar. The president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), John Castellani, issued the following statement immediately after India granted the CL for the indigenous production of Nexavar's generic version:

While India has not routinely issued CLs, PhRMA believes it is not an appropriate tool even if granting CLs may be a legal option. Legitimate health emergencies that require making exceptions to IPRs can, and should, be accommodated under the international framework, but only after exhausting all other efforts and under extraordinary circumstances. [O]ne aspect that is particularly troublesome is the contention that working' a patent requires a company to manufacture within India. It is our firm belief that this is fully at odds with India's TRIPS commitments (as well as broader WTO obligations), and distorts what was intended as a public health exception into an industrial policy. CLs cannot solve India's larger problems regarding access to medicines and health care.

The PhRMA's contentions are patently wrong as the decision is in full compliance with the Doha Declaration on the TRIPS Agreement and Public Health of November 2001 and Article 31 of TRIPS. But the protest was conveyed more brazenly to the Indian government when the visiting United States Commerce Secretary, John Bryson, raised the issue of India granting a CL to Natco in his meeting with Commerce and Industry Minister Anand Sharma on March 25. Bryson apparently said that any dilution of the international patent regime was a cause for deep concern for the U.S. This was clearly an unwarranted remark on the part of the U.S. official because if there was any perceived violation of TRIPS, the correct forum for the U.S. to address the issue was the WTO.

The U.S. has instituted an internal mechanism under its trade policy to deal with what it perceives as trade barriers in its trading-partner countries on the basis of an annual assessment in what is called the Special 301 Report by the office of the U.S. Trade Representative (USTR). India has consistently been placed in the Priority Watch List of the report. Following the court's rejection of Novartis' appeal in 2009, the 2010 report included a response of the USTR to the Indian decision.

The report said: The United States continues to urge India to improve its IPR regime by providing stronger protection for patents. One concern in this regard is a provision in India's Patent Law that prohibits patents on certain chemical forms absent a showing of increased efficacy. While the full import of this provision remains unclear, it appears to limit the patentability of potentially beneficial innovations, such as temperature-stable forms of a drug or new means of drug delivery (emphasis added, throughout).

The wording clearly reflects the U.S.' objection to the Indian patent office not granting a new patent for a new chemical form of a patented drug that the manufacturer claims had increased bioabsorption but for which there was no proven increased therapeutic efficacy. The 2011 report, too, essentially repeated the same objection to the restricted scope of patentability of drugs under the Patents Act. The administration's objection to the Bayer-Nexavar case is bound to be reflected in the 2012 report, given that the PhRMA has already voiced its protest. Drugs are big business around the world for the U.S. industry, and the PhRMA, which acts as the prime lobby group for the U.S. drug industry, naturally has a major influence on the contents of the Special 301 Report.

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In its submission to the USTR on the 2012 Special 301 Report, the PhRMA said the following with regard to the patentability criteria exercised by the Indian patent office in the Novartis case: Some of the standards for patentability in India are not transparent and are inconsistent with the TRIPS Agreement. For example, Section 3(d) of the [Indian] Patents Act creates additional hurdles to the grant of certain chemical compound patents, and appears to be applied only to pharmaceuticals. Under this provision, salts, esters, ethers, polymorphs, and other derivatives of known substances are presumed to be the same substance as the original chemical and thus not patentable, unless it can be shown that they differ significantly in properties with regard to efficacy. These additional requirements for patentability beyond novelty, commercial applicability and non-obviousness are inconsistent with the TRIPS Agreement.... Article 27 of the TRIPS Agreement provides a non-extendable list of the types of subject matter that can be excluded from patent coverage. This list does not include new forms of known substances lacking enhanced efficacy', as excluded by Section 3(d) of the Indian law. This argument is misplaced because the rejection is on the grounds of the new drug not meeting the basic criterion of patentability, which is novelty, meaning that it should be a new compound and should involve an inventive step. Novartis was seeking a patent for just the beta crystalline variant of a patented amorphous molecule, claiming merely better bioavailability. Such an incremental modification is not something that involves inventiveness, the court contended.

On the issue of CLs, which is another key issue of concern to the PhRMA, its submission, made in February, a month before the decision on the Bayer case was pronounced, stated: Domestic companies have started filing CL applications with the Indian patent office, apparently prompted in part by government statements suggesting that CLs may be a means for ensuring availability and affordability of drugs worldwide. At a minimum, India should ensure that the CL provisions comply with TRIPS by... eliminating price as a trigger to CL. (Section 84(1) (b) of the Indian Patents Act permits a CL if the patented invention is not available to the public at a reasonably affordable price.)

This again is a misplaced objection because a country is free to decide on the reasons for granting a CL as is clear from the Doha Declaration, which says: Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted; Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. The patent office exercised the freedom of granting the CL to Natco on the issue of affordability, given that Natco's generic drug will cost Rs.8,800 a month as against Bayer's Rs.2.8 lakh a month and that cancer treatment is lifelong.

Retaliation following the listing of a country on the watch list includes the U.S. initiating dispute settlement mechanisms at international trade forums such as the WTO, elimination of preferential tariff preferences under bilateral trade agreements, if any, and even unilateral trade sanctions against the named country. Bryson's remarks are perhaps a veiled threat of such action against India since there are many such pharmaceutical patent cases pending in Indian courts for which these cases could become precedents, affecting the potentially huge market of American MNCs.

Trade policy forum

There exists a bilateral engagement between India and the U.S. under what is called the U.S.-India Trade Policy Forum (TPF) formed in 2005 alongside the various India-U.S. agreements that came into being, including the nuclear deal. The TPF has five focus groups: agriculture, investment, innovation and creativity (IPR), services, and tariff and non-tariff barriers. Under the TPF, a framework for cooperation and trade was signed two years ago.

Although its proposed work plan does not specifically mention IPR, it does include a group focussing on tariff and non-tariff barriers, which is aimed at promoting policies to expand market access, including adopting transparent, WTO-policies. It is quite likely that this bilateral forum will begin to be used by the U.S. to bring on pressure on contentious issues concerning IPR.

Interestingly, the scheduled meeting of the TPF has been postponed twice by the U.S. since October, the most recent being the meeting of the Commerce Minister with USTR Ron Kirk in January. According to media reports, this is because of insufficient progress achieved on the various issues, increasing market access to U.S. companies, in particular. Clearly, the U.S. will increase pressure on the IPR issue in the wake of the recent CL decision at the next meeting of the TPF, which has been pushed to mid-2012. The Indian government would do well to guard against that. Health-care activists and IPR experts have voiced similar concern over the proposed India-European Union (E.U.) Free Trade Agreement (FTA).

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According to reports, the 27-nation bloc has been pressing India to agree to an IPR regime over and above TRIPS. This demand is related to the area of pharmaceuticals, particularly after the Novartis decision, and this demand in all likelihood will become stronger now. Recently, however, Minister Anand Sharma assured a visiting UNAIDS (Joint United Nations Programme on HIV/AIDS) executive that India would reject efforts to include a data exclusivity clause in bilateral agreements and affirmed the Indian government's full commitment to ensure quality generic medicines through compulsory licensing and other TRIPS flexibilities. Notwithstanding this, in a recent article in The Guardian, Philippe Douste-Blazy, U.N. Special Adviser on Innovative Financing for Development, and Denis Broun, Executive Director of Unitaid, an international facility for the purchase of drugs for HIV/AIDS, malaria and tuberculosis hosted by the World Health Organisation in Geneva, wrote: If stringent patent and border measures are agreed on at the E.U.-India FTA summit, patients in poor countries will no longer have access to cheap generic medicines; India's role as the pharmacy of the South' could well come to an end.

The U.S. has already begun to exert such pressures and force countries in some other parts of the world into accepting IPR protection standards that are stronger than the TRIPS regime. Under the Trans-Pacific Partnership, a multilateral free trade agreement between the U.S. and the countries of the Asia-Pacific region that seeks to further liberalise these economies, the U.S. intends to broaden the scope of patentability by eroding the flexibility afforded by TRIPS by requesting TPP partner countries to pass new laws and rules that severely limit the ability of each country to define what is patentable. The nine countries currently negotiating the TPP are Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the U.S. and Vietnam. Japan and South Korea are intending to join the group shortly.

A leaked draft of the chapter on IPR in a U.S.-negotiating TPP text, which reflects the U.S. position on this multilateral arrangement, indicates that the U.S. is demanding aggressive IPR provisions that go beyond what international trade law (under TRIPS) requires: Each Party, says the draft U.S. proposal, shall confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product. This is the patent evergreening technique that Novartis tried to employ, which the Indian patent office rejected. Evergreening of a patent allows pharmaceutical companies to obtain or extend monopoly protection for old drugs simply by making minor modifications to existing formulae. The international organisation Medecins Sans Frontieres (Doctors Without Borders), which provides affordable health care around the world, points out: Evergreening significantly delays the arrival of more affordable generic medicines into the market. The TPP draft text further wants plants and animals and diagnostic, therapeutic and surgical methods for the treatment of humans or animals, which are explicitly ruled by TRIPS to be non-patentable, to be patentable.

In addition, another leaked document pertaining to the TPP seeks to eliminate the process of pre-grant opposition to a patent application, which is an important tool to prevent patent applications based on weak or erroneous information. The U.S. proposal, if accepted, would allow opposition only after the patent is granted.

Although this does not directly or immediately affect the Indian situation, it does portend ominous moves on this front by the U.S. on India as well. This is evident from the remarks Ron Kirk made recently: U.S. involvement in the TPP is predicated on the expansion of the agreement to include more economies in the Asia-Pacific region[and] should set the standard for 21st century trade agreements going forward.

It, therefore, stands to reason that the norms that emerge from the TPP negotiations will serve as the template for future U.S. trade agreements across the world. Using the leverage of the many countries in the TPP fold, and perhaps in other bilateral agreements, which accept this new enlarged premise for patentability, the WTO, too, eventually might come under pressure to change its rules of dispute settlement and arbitration. The implications of this are that IPR regimes, in particular the strict patentability criteria for drugs, of countries such as India, which have the responsibility of extending affordable health care to millions, will increasingly come under severe attack from the U.S. and the E.U., where nearly all the big drug multinationals operate and profit at the cost of the suffering poor of developing countries.

Question of efficacy

LEENA MENGHANEY cover-story

The country is clearly shaping its legislation to promote access to medicines by fostering generic production.

INDIA'S approach to the revision of its Patents Act in 2005 is a clear example of a country shaping its legislation to promote access to medicines by fostering generic production. Although World Trade Organisation (WTO) rules made it mandatory for India to put in place a patent regime for medicines by 2005, nothing obliges developing countries such as India to replicate the patent system of wealthy countries, which involves charging the highest possible price and protecting that price through patent monopolies that extend way beyond 20 years.

India has used important flexibilities under international law to include provisions in its domestic patent law not only to reduce the number of secondary patents but also to have a licensing mechanism that kicks in with excessive pricing of patented medicines. The application of these safeguards by the Indian patent office benefiting patients in India and other developing countries is increasingly inviting the ire of the multinational pharmaceutical industry and its associations.

The Indian government is faced with court cases and the diplomatic offensive that the protectors of the pharmaceutical industry in the United States and the European Union are now launching.

In India, the importance of generic (local) production of medicines in fostering competition and reducing prices was first recognised by lawmakers in the Patents Act of 1970, which brought in a legal regime that did not allow product patents on pharmaceuticals. In the following decades, India not only was successful in making drugs affordable but also significantly increased their availability by building domestic capacity to produce essential and life-saving drugs. It also went on to become the pharmacy of the developing world, supplying medicines to countries that lacked the capacity and resources to produce the drugs themselves or pay the high prices demanded by originator pharmaceutical companies.

The production of more affordable generic medicines in India has been instrumental in driving down the price of AIDS (acquired immune deficiency syndrome) medicines by 99 per cent, and nearly six million people living with HIV have been put on treatment on Indian generic medicines in the past 10 years.

In 2005, India was obliged to change its patent law in order to comply with its obligations as a member of the WTO, bringing into effect the TRIPS Agreement. The most significant change was the introduction of product patents for medicines. When framing the new patent legislation in 2005, Parliament sought to ensure that provisions to protect public health and access to medicines were incorporated into it. It, therefore, included explicit legal safeguards and guidance on how the patentability requirements should be applied.

In particular, evergreening, a well-known abuse of the patent system where companies seek new monopolies or, alternatively, extend a monopoly by seeking to patent minor changes such as new uses, new forms and other routine improvements of known medicines was addressed. Section 3(d) of the Indian Patents Act explicitly allows the broad exclusion from patentability of new uses and new forms of known medicines. In sum, Section 3(d) gave explicit guidance to the Indian patent office on how to weed out patent claims on routine improvements of known medicines and protect the country's capacity to act as a factory for the production and supply of affordable generic medicines.

Legal challenge

In 2006, in a landmark decision, the Indian patent office rejected Swiss pharmaceutical company Novartis' patent application for the life-saving anti-cancer drug imatinib mesylate. The application for a patent on a beta crystalline salt form of imatinib was rejected on the grounds that it lacked novelty, was obvious, and was un-patentable under Section 3(d) of the Patents Act. In retaliation, Novartis mounted a legal challenge to have Section 3(d) declared unconstitutional. Medecins Sans Frontieres (MSF) launched an international campaign calling on the company to drop the case, attracting close to half a million signatures. In 2007, the Madras High Court rejected Novartis' plea and in 2009 the Intellectual Property Appellate Board (IPAB) rejected its patent application on imatinib mesylate once again.

But the company is not backing down. After failing to have Section 3(d) struck down, it is now again seeking to limit its effect. In 2009, Novartis filed a special leave petition in the Supreme Court against India in relation to the patentability criteria to be applied to imatinib mesylate.

Under Section 3(d) of the Patents Act, new forms of already known substances cannot be patented if they fail to demonstrate the required degree of efficacy; it requires demonstration of increased efficacy for a medicine to deserve a patent. The interpretation of the definition of efficacy is therefore central to this case and to the future of India's role as the pharmacy of the developing world.

In 2007, in its constitutional challenge against Section 3(d) before the Madras High Court, Novartis had argued that increased bioavailability of the salt form of imatinib meant increased efficacy, entitling it to a patent. But the High Court clarified that efficacy meant therapeutic effect in healing a disease.

The IPAB, where appeals for unsuccessful patent applications are heard, subsequently applied this interpretation and held that the salt form of imatinib mesylate did not meet the test of therapeutic efficacy. It, therefore, confirmed the rejection of Novartis's patent application.

High standards crucial for tests in patent law

Setting high standards for the various tests in the patent legislation, particularly the efficacy test of Section 3(d) and the inventive step requirement, leading to fewer patents on new forms of known medicines, is important to safeguard access to affordable generic medicines from India. Novartis has now taken its case to the Supreme Court to argue against the interpretation of efficacy in Section 3(d) by the Madras High Court and the IPAB. This case has the potential to severely affect access to affordable essential medicines for millions of people across the developing world. It will determine whether Section 3(d) will continue to ensure that patents are granted only on medicines that are truly new and inventive. Many developing countries rely on affordable medicines produced in India, and such medicines constitute over 80 per cent of the AIDS drugs used in the developing world. MSF is closely following the outcome of this case.

Novartis is basing its claim for a patent on the salt of imatinib on the fact that there is a 30 per cent increase in the bioavailability of the drug in this new form. But, according to the guidelines for the examination of pharmaceutical patents developed by the World Health Organisation (WHO) and the International Centre for Trade and Sustainable Development (ICTSD), the selection of a salt of the active ingredient with the purpose to improve bioavailability is known in pharmaceutical science. It is common knowledge in the field that salts result in different solubility and, therefore, in different bioavailability.

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The final arguments in the case have started. The next date of hearing is set for July 10. If Novartis wins, many other medicines, even those that show no increased therapeutic efficacy, will be patentable in India, and the availability of affordable medicines will be threatened. If the substance is taken out of Section 3(d), abusive evergreening practices, where drug companies maintain artificially high prices on medicines well beyond the original patent period by securing fresh patents on minor modifications of existing drugs, will become rampant in the future.

If, on the other hand, the high threshold for patentability is upheld, generic production will continue to drive the price of life-saving medicines down. Multinational pharmaceutical companies such as Novartis will find it difficult to argue that routine improvements such as new forms of existing medicines that result in improved stability, enhanced bioavailability, increased solubility, improved flow properties and lower hygroscopicity meet the efficacy requirements of Section 3(d). In addition, the improved therapeutic efficacy would have to be supported with actual clinical data that demonstrate this effect.

The Supreme Court case is the final act in a legal battle that stretches back over six years between Novartis and the Indian government. The government, hopefully, will argue for a strict interpretation of efficacy so that patents on new forms of known medicines such as the one on the cancer drug imatinib mesylate are not granted as a matter of routine by the country's patent office. Novartis has lined up very senior and very expensive lawyers, including two former Solicitors General, to argue its case. But there appears to be no information on whether the government has appointed its own top lawyer, the Attorney General, in this case.

Opening the door for compulsory licensing

In another test case on access to treatment, seven years after India revised its 1970 Patents Act, the Controller General of Patents issued the first-ever compulsory licence (CL) to the Hyderabad-based company Natco to produce an affordable version of a patented anti-cancer medicine (sorafenib tosylate) of the German pharmaceutical company Bayer Corporation, marketed under the brand name of Nexavar. The generic version produced by Natco, which will pay 6 per cent royalty on net sales to Bayer, will be 97 per cent cheaper.

The decision was made on the basis of the fact that not only had the patentee, Bayer, failed to price sorafenib tosylate at a level that made it accessible and affordable but it was also unable to ensure that the medicine was available in sufficient and sustainable quantities within India. Bayer has time until mid-June to appeal against the order.

Like many other giant drug companies, Bayer defended the inflated cost of sorafenib by specifying the high spending on research and development. However, what it did not highlight was that the United States National Institutes of Health had sponsored almost 70 per cent of the second phase of its clinical trials. Later, this drug was given an orphan drug designation by the U.S.' Food and Drug Administration (FDA) for the treatment of renal cell carcinoma, entitling Bayer to 50 per cent tax credits, which further lowered the company's costs for the third and most expensive phase of clinical trials.

The CL is quickly being dubbed by pharmaceutical companies such as Novartis as a move that will stifle innovation. Indeed, pharmaceutical companies at present try to recover their investments by charging excessively high prices and protecting their drugs through patent monopolies. However, R&D costs are only a fraction of the profits thus made, and a large part of the profits are spent on brand-building and marketing. In 2011, Bayer spent nearly 9 billion on sales and advertising. In the same period, only 2.9 billion was spent on research.

The patent system also has another drawback. Innovation currently fails to address the needs of patients in developing countries.

The drug companies also repeatedly warn that measures such as the CL adversely affect the confidence of foreign investors. But a study published in Thailand in 2009 by the Health Intervention and Technology Assessment Program (HITAP) found little evidence of a link between the granting of CLs and the level of foreign direct investment (FDI) in the country.

The recently granted CL actually highlights a potentially new patent model that routinely allows low-cost alternatives in lieu of royalty payments, not only helping originators to recoup their development costs but also ensuring that people in developing countries have access to medicines. It is in line with licensing decisions in other jurisdictions. Recently, a U.S. court decided not to prevent a competitor from marketing a medical device used for skin grafts, and instead put in place a system of royalties from the competitor to the patent owner. At the core of this decision was the idea that the public has a right to access innovative health products and this should not be blocked by excessive prices.

The Novartis and Bayer cases highlight that the country is entering a new era in which disputes on the public's access to and the affordability of drugs will become more frequent.

Leena Menghaney is campaign coordinator of Medecins Sans Frontieres in India and is based in New Delhi.

Drug and duplicity

cover-story

NOVARTIS has long been suing the Government of India to eliminate or weaken Section 3(d) of the Patents (Amendment) Act, 2005, which established strict standards of patentability in order to prevent the ever-greening of patent monopolies on medicines. Although Novartis lost in 2007 its initial efforts to have Section 3(d) declared unconstitutional and violative of international norms for national patent regimes, it has persisted in appealing and re-appealing the denial of its patent application on Glivec, a key anti-cancer medicine whose basic ingredient was invented in 1993, well before India was required to begin granting patents on pharmaceutical products.

Novartis' latest appeal before the Supreme Court of India is scheduled to be heard in July. In that hearing, Novartis will ask the court to eviscerate the existing interpretation of Section 3(d), which limits patents on new forms and versions of existing chemical entities to those rare circumstances when such routine modifications result in a significant improvement in efficacy in terms of treatment of human illness. Novartis wants minor improvements in absorption or stability of the medicine to justify an additional 20-year monopoly.

In previous press statements, Novartis India has said that it is merely seeking clarity on the unique provisions of the Patents Act and that it is not trying to undermine lawful flexibilities in India or elsewhere with respect to the promotion of more affordable medicines. It has specifically said that it respects India's rights under international and domestic law to issue compulsory licences (permission to a generic competitor to make and sell an equivalent product). That was until India actually issued its first compulsory licence on Bayer's cancer medicine, sorafenib, on March 12. There, the Patent Controller ruled that Bayer had neglected to meet the reasonable requirements of the public, that it had charged an unreasonable price ($66,812 per patient a year!) and that it had not worked the product in India by means of any local manufacture.

Following the issuance of the Bayer compulsory licence, Novartis's publicity machinery changed its tune. On March 14, in The Times of India, Novartis' local representative in India, Ranjit Shahani, wrote: Compulsory licences are powerful rights granted to governments to deal with extraordinary circumstances such as a national health crisis and must hence be used with extreme prudence. As per TRIPS, WTO member states can grant a compulsory licence in case of national emergency, in case of public non-commercial use, in case of anti-competitive practices or in case of a dependent patent if additional criteria are met. If used injudiciously, compulsory licences will in fact work to the detriment of the patient through the negative impact they will have on future investment in innovative pharmaceuticals.

This statement grossly misstates the operative legal standards for compulsory licences under Article 31 of the World Trade Organisation's (WTO) TRIPS Agreement, but it helps to bring to light Novartis' real position on India's right to issue compulsory licences. Compulsory licences, as made clear both in Article 31 and in the Doha Declaration on the TRIPS Agreement and Public Health, are not limited to extraordinary circumstances, let alone to the narrow set of national emergencies, government use, anti-competitive remedies, or dependent patents listed by Shahani. WTO member states, including India, are free to determine any and all grounds upon which compulsory licences may be issued, with explicit acknowledgement that they may do so to promote public health and access to medicines for all.

India's issuance of a compulsory licence on Bayer's sorafenib was not injudicious. The Patent Controller's findings were detailed and fully weighed all of the arguments advanced by Bayer. In the end, however, the conclusion was easy pricing a medicine so that fewer than 200 cancer patients in India could access it, instead of the thousands who needed it, justified a licence to Natco, which could make and sell the same medicine at 3 per cent of the Bayer price while still making a profit and paying a 6 per cent royalty to Bayer. Health activists are hopeful that the sorafenib case will establish a strong precedent for more frequent compulsory licences on key HIV/AIDS, cancer, and psychiatric medicines, indeed, on medicines more generally.

Novartis's overzealous defence of intellectual property rights knows no bounds. It seeks to strengthen and lengthen patent monopolies and prevent the use of hard-fought flexibilities that ensure that poor people will not be left to die. Yet, it has issued pious statements in the past about its benign intentions with respect to the use of lawful TRIPS flexibilities. Now, the faade has been removed to reveal the naked greed that actually motivates Novartis' attack both on its lawful adoption of high standards for patents and on India's use of well-established flexibilities that have been recognised internationally for a century and a half.

Brook K. Baker

Professor Brook K. Baker is with Health GAP (Global Access Project), Northeastern University School of Law Program on Human Rights and the Global Economy, Boston. He is also Honorary Research Fellow, University of KwaZulu Natal, Durban, South Africa.

A welcome first

T.K. RAJALAKSHMI cover-story

Industry reacts with caution to the grant of a compulsory licence to Natco, but cancer patients welcome it and hope for many more.

THE first compulsory licence (CL) issued by the Indian patent office, to the local drug manufacturer Natco Pharma Ltd to sell the generic version of Bayer AG's anti-cancer drug Nexavar, has led to varied reactions. The landmark decision has also raised concerns about the outcome of cases of a similar nature pending in court. The decision also assumes importance in the context of the government's plan to deliver universal health care as recommended by the high-level expert group appointed by the Planning Commission. Incidentally, the generic form of the drug is still expensive for many, at Rs.8,800 for a month.

While the pharmaceutical industry has reacted to the decision with overarching caution and disappointment, cancer patients have welcomed it and are hopeful of many more similar decisions. The Organisation of Pharmaceutical Producers of India (OPPI), a platform largely of foreign companies, expressed disappointment with the judgment. In a statement, Ranjit Shahani, OPPI president and head of Novartis India, held that compulsory licences should be used only in exceptional circumstances, such as in times of a national health crisis. If used arbitrarily, compulsory licences will serve to undermine the innovative pharmaceutical industry and will be to the long-term detriment of the patient, he said. His argument is that for better access, improved health-care infrastructure and distribution are needed. Pharmaceutical companies have argued that they can have a system of differential pricing for different countries.

According to S. Srinivasan of the Vadodara-based organisation LOCOST (Low Cost Standard Therapeutics), differential pricing has never worked. It depends on the market which is the beneficiary and whether there won't be reverse leakages in the market. It also has a bit of elimination of manipulation of the market without market forces coming into play fully, and [it] can also be an argument against compulsory licences and local development of technology and backward integration. It is a bit like voluntary licensing of, say, Tenofovir without even benefits of any semblance of local manufacturing, such as it is with a voluntary licence. Generally, it is a device to hold a market captive and dependent on one manufacturer, usually the innovator. More importantly, it inhibits any questioning of pricing and costing per se of the product, investing the manufacturer with an undeserved halo, he told Frontline.

The basic issue is that these drugs are priced completely out of reach for the poor person, said a cancer patient who is on Glivec, which he accesses free at a leading government hospital in Delhi. He toldFrontline on condition of anonymity that the outpatient ward of the hospital was crowded with blood cancer patients. The medicine was being given free under the Access Programme of the company. In that particular hospital, there were three OPD sessions in a week, with each session being attended by nearly 125 patients, he said. The bulk of the patients came from the rural hinterland and there were very few patients from the middle classes, he added.

This is what happens just in one hospital. One can only imagine the number of needy patients, he said. He said that if he bought it from the open market, it would cost him Rs.1.5-2 lakh a month. The only reason I am able to use the drug is that even as exclusive marketing rights were given to the company, the condition was that it would provide the drug to needy people. In the case of this drug, the court held that under the Indian patent law generic production was permissible and rejected the patent on the drug. The company has challenged this in the Supreme Court.

He said that even for the needy persons, proof of income was demanded by the company. I am an income-tax payer and I legitimately file my tax returns. I passed the criteria to get the medicines free, he said. The government, he added, had taken a proactive line after the Left parties pressured the government to make several changes to the Indian Patents Act in 2005. The Left parties proposed as many as 13 amendments to the draft Patent (Third) Amendment Bill, 11 of which were passed by Parliament, he said.

As one who has been on the drug for nearly six years, he said he had to buy it from the market for the first four months. He said: I used to pay Rs.14,500 then, which was roughly equivalent to my monthly salary. Then I applied for the scheme and my application was sent back to the parent company. I have learnt now that the company has circulated a letter to all its patients stating that from 2012 onwards all new patients will have to pay Rs.10,000 a year and that they will not be able to provide the medicine free any longer. I cannot say I am out of the woods, but without this drug I wouldn't be talking to you today.

The Indian Drug Manufacturers' Association (IDMA), too, has welcomed the compulsory licence awarded to Natco. Gajanan Wakankar, executive director of the IDMA, said it was a very good step for cancer patients and for the government, which appeared committed to providing access to medicines. Between profit and profiteering, there is a very thin line. In this particular case, involving Bayer, it was not a case of reasonable profits, he said.

Compulsory licensing, he said, was a provision accepted under TRIPS [Trade-Related Aspects of Intellectual Property Rights] and was applicable all over the world, including the United States. The prime reason was to prevent the abuse of monopolies. Multinational firms should recover their costs incurred in research and development, but when the costs exceeded by a wide margin it was tantamount to profiteering, he said. The decision of the patent office seemed to have had a positive effect, he added.

On the issue of differential pricing by pharma companies, Gajanan Wakankar said there were ways to do it under the voluntary licensing system, but most companies were not doing it. He gave the example of the anthrax scare in the U.S., where the government threatened to issue a compulsory licence for the cure, and thereby ensured a reduction in the price.

He said Natco, which happens to be one of the IDMA's oldest members, had wanted a voluntary licence from Bayer for the drug but the latter refused. He explained that drug production even under compulsory licensing was difficult for ordinary companies because they had to employ highly qualified scientists who had the expertise and know-how to produce the same. The IDMA was largely responsible for pushing and drafting the Patents (Amendment) Act, 2005. There will be litigation but we hope that the law stands the test, he said.

Loon Gangte, representative of the Delhi Network of Positive (HIV) People, also welcomed the patent office's order, terming it a beautiful precedent. He said all third-line and second-line HIV drugs were patented. While the government had started rolling out second-line drugs, it was a matter of time before resistance would develop and third-line treatment would be required, he said. He said that while the government was being proactive, it was also a fact that there was not a single HIV drug that was not patented.

Western warnings

R. RAMACHANDRAN cover-story

India is coming under increasing pressure from the U.S. and the European Union for the strict patentability criteria it applies for medicines.

AS was only to be expected, the two landmark decisions made by the Indian patent office in recent times concerning pharmaceutical patent cases have not gone down well with the multinational drug industry. First, there was the rejection in 2006 of the patent application by the Swiss multinational Novartis for imatinib mesylate (sold under the brand name of Glivec, or Gleevec), its incrementally modified drug for leukaemia, or blood cancer. Then, on March 12, 2012, the Indian generic drug company Natco Pharma Ltd was granted a manufacturing licence to produce a generic version of the patented liver and kidney cancer drug sorafenib tosylate of the German multinational company (MNC) Bayer (brand name Nexavar) through the first-ever invocation of the compulsory licence (CL) provision in the Indian Patents Act, 1970 (as amended in 2005). The CL was granted to ensure affordability of the drug to Indian cancer patients. Natco will now produce the drug at a price that will be 97 per cent lower than Bayer's even after paying 6 per cent royalty on net sales to Bayer.

Bayer will most likely appeal against the order. Novartis challenged the patent office's rejection of its patent application first at the Intellectual Property Appellate Board (IPAB) and subsequently in the Madras High Court. Both upheld the Patent Controller's decision and rejected Novartis' appeals against the Indian government. Now the company has appealed to the Supreme Court. The first hearing is slated for July 10. These two cases have demonstrated how flexibilities available in the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement (for patent protection) of the World Trade Organisation (WTO) can be successfully used to serve public health interests in developing countries over the interests of the private monopoly of profit-driven drug MNCs. The flexibilities in the TRIPS Agreement allow governments to decide what type of innovation is patentable. The criteria of novelty, inventive step, and industrial applicability are not defined in the agreement and are left for individual governments to determine within existing national legislation and circumstances. These are also, therefore, test cases for the Indian judiciary, and if these orders can be sustained in the face of imminent legal battles, they will serve as important precedents for exploiting the full power of the Indian Patents Act, while conforming to the WTO's intellectual property rights (IPR) regime, to ensure the Indian public access to health care it can afford.

Drug majors around the world, American companies in particular, which have, of course, been watching the Novartis case anxiously for the past five years, have been further jolted by the latest decision on Nexavar. The president and chief executive officer of the Pharmaceutical Research and Manufacturers of America (PhRMA), John Castellani, issued the following statement immediately after India granted the CL for the indigenous production of Nexavar's generic version:

While India has not routinely issued CLs, PhRMA believes it is not an appropriate tool even if granting CLs may be a legal option. Legitimate health emergencies that require making exceptions to IPRs can, and should, be accommodated under the international framework, but only after exhausting all other efforts and under extraordinary circumstances. [O]ne aspect that is particularly troublesome is the contention that working' a patent requires a company to manufacture within India. It is our firm belief that this is fully at odds with India's TRIPS commitments (as well as broader WTO obligations), and distorts what was intended as a public health exception into an industrial policy. CLs cannot solve India's larger problems regarding access to medicines and health care.

The PhRMA's contentions are patently wrong as the decision is in full compliance with the Doha Declaration on the TRIPS Agreement and Public Health of November 2001 and Article 31 of TRIPS. But the protest was conveyed more brazenly to the Indian government when the visiting United States Commerce Secretary, John Bryson, raised the issue of India granting a CL to Natco in his meeting with Commerce and Industry Minister Anand Sharma on March 25. Bryson apparently said that any dilution of the international patent regime was a cause for deep concern for the U.S. This was clearly an unwarranted remark on the part of the U.S. official because if there was any perceived violation of TRIPS, the correct forum for the U.S. to address the issue was the WTO.

The U.S. has instituted an internal mechanism under its trade policy to deal with what it perceives as trade barriers in its trading-partner countries on the basis of an annual assessment in what is called the Special 301 Report by the office of the U.S. Trade Representative (USTR). India has consistently been placed in the Priority Watch List of the report. Following the court's rejection of Novartis' appeal in 2009, the 2010 report included a response of the USTR to the Indian decision.

The report said: The United States continues to urge India to improve its IPR regime by providing stronger protection for patents. One concern in this regard is a provision in India's Patent Law that prohibits patents on certain chemical forms absent a showing of increased efficacy. While the full import of this provision remains unclear, it appears to limit the patentability of potentially beneficial innovations, such as temperature-stable forms of a drug or new means of drug delivery (emphasis added, throughout).

The wording clearly reflects the U.S.' objection to the Indian patent office not granting a new patent for a new chemical form of a patented drug that the manufacturer claims had increased bioabsorption but for which there was no proven increased therapeutic efficacy. The 2011 report, too, essentially repeated the same objection to the restricted scope of patentability of drugs under the Patents Act. The administration's objection to the Bayer-Nexavar case is bound to be reflected in the 2012 report, given that the PhRMA has already voiced its protest. Drugs are big business around the world for the U.S. industry, and the PhRMA, which acts as the prime lobby group for the U.S. drug industry, naturally has a major influence on the contents of the Special 301 Report.

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In its submission to the USTR on the 2012 Special 301 Report, the PhRMA said the following with regard to the patentability criteria exercised by the Indian patent office in the Novartis case: Some of the standards for patentability in India are not transparent and are inconsistent with the TRIPS Agreement. For example, Section 3(d) of the [Indian] Patents Act creates additional hurdles to the grant of certain chemical compound patents, and appears to be applied only to pharmaceuticals. Under this provision, salts, esters, ethers, polymorphs, and other derivatives of known substances are presumed to be the same substance as the original chemical and thus not patentable, unless it can be shown that they differ significantly in properties with regard to efficacy. These additional requirements for patentability beyond novelty, commercial applicability and non-obviousness are inconsistent with the TRIPS Agreement.... Article 27 of the TRIPS Agreement provides a non-extendable list of the types of subject matter that can be excluded from patent coverage. This list does not include new forms of known substances lacking enhanced efficacy', as excluded by Section 3(d) of the Indian law. This argument is misplaced because the rejection is on the grounds of the new drug not meeting the basic criterion of patentability, which is novelty, meaning that it should be a new compound and should involve an inventive step. Novartis was seeking a patent for just the beta crystalline variant of a patented amorphous molecule, claiming merely better bioavailability. Such an incremental modification is not something that involves inventiveness, the court contended.

On the issue of CLs, which is another key issue of concern to the PhRMA, its submission, made in February, a month before the decision on the Bayer case was pronounced, stated: Domestic companies have started filing CL applications with the Indian patent office, apparently prompted in part by government statements suggesting that CLs may be a means for ensuring availability and affordability of drugs worldwide. At a minimum, India should ensure that the CL provisions comply with TRIPS by... eliminating price as a trigger to CL. (Section 84(1) (b) of the Indian Patents Act permits a CL if the patented invention is not available to the public at a reasonably affordable price.)

This again is a misplaced objection because a country is free to decide on the reasons for granting a CL as is clear from the Doha Declaration, which says: Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted; Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency. The patent office exercised the freedom of granting the CL to Natco on the issue of affordability, given that Natco's generic drug will cost Rs.8,800 a month as against Bayer's Rs.2.8 lakh a month and that cancer treatment is lifelong.

Retaliation following the listing of a country on the watch list includes the U.S. initiating dispute settlement mechanisms at international trade forums such as the WTO, elimination of preferential tariff preferences under bilateral trade agreements, if any, and even unilateral trade sanctions against the named country. Bryson's remarks are perhaps a veiled threat of such action against India since there are many such pharmaceutical patent cases pending in Indian courts for which these cases could become precedents, affecting the potentially huge market of American MNCs.

Trade policy forum

There exists a bilateral engagement between India and the U.S. under what is called the U.S.-India Trade Policy Forum (TPF) formed in 2005 alongside the various India-U.S. agreements that came into being, including the nuclear deal. The TPF has five focus groups: agriculture, investment, innovation and creativity (IPR), services, and tariff and non-tariff barriers. Under the TPF, a framework for cooperation and trade was signed two years ago.

Although its proposed work plan does not specifically mention IPR, it does include a group focussing on tariff and non-tariff barriers, which is aimed at promoting policies to expand market access, including adopting transparent, WTO-policies. It is quite likely that this bilateral forum will begin to be used by the U.S. to bring on pressure on contentious issues concerning IPR.

Interestingly, the scheduled meeting of the TPF has been postponed twice by the U.S. since October, the most recent being the meeting of the Commerce Minister with USTR Ron Kirk in January. According to media reports, this is because of insufficient progress achieved on the various issues, increasing market access to U.S. companies, in particular. Clearly, the U.S. will increase pressure on the IPR issue in the wake of the recent CL decision at the next meeting of the TPF, which has been pushed to mid-2012. The Indian government would do well to guard against that. Health-care activists and IPR experts have voiced similar concern over the proposed India-European Union (E.U.) Free Trade Agreement (FTA).

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According to reports, the 27-nation bloc has been pressing India to agree to an IPR regime over and above TRIPS. This demand is related to the area of pharmaceuticals, particularly after the Novartis decision, and this demand in all likelihood will become stronger now. Recently, however, Minister Anand Sharma assured a visiting UNAIDS (Joint United Nations Programme on HIV/AIDS) executive that India would reject efforts to include a data exclusivity clause in bilateral agreements and affirmed the Indian government's full commitment to ensure quality generic medicines through compulsory licensing and other TRIPS flexibilities. Notwithstanding this, in a recent article in The Guardian, Philippe Douste-Blazy, U.N. Special Adviser on Innovative Financing for Development, and Denis Broun, Executive Director of Unitaid, an international facility for the purchase of drugs for HIV/AIDS, malaria and tuberculosis hosted by the World Health Organisation in Geneva, wrote: If stringent patent and border measures are agreed on at the E.U.-India FTA summit, patients in poor countries will no longer have access to cheap generic medicines; India's role as the pharmacy of the South' could well come to an end.

The U.S. has already begun to exert such pressures and force countries in some other parts of the world into accepting IPR protection standards that are stronger than the TRIPS regime. Under the Trans-Pacific Partnership, a multilateral free trade agreement between the U.S. and the countries of the Asia-Pacific region that seeks to further liberalise these economies, the U.S. intends to broaden the scope of patentability by eroding the flexibility afforded by TRIPS by requesting TPP partner countries to pass new laws and rules that severely limit the ability of each country to define what is patentable. The nine countries currently negotiating the TPP are Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore, the U.S. and Vietnam. Japan and South Korea are intending to join the group shortly.

A leaked draft of the chapter on IPR in a U.S.-negotiating TPP text, which reflects the U.S. position on this multilateral arrangement, indicates that the U.S. is demanding aggressive IPR provisions that go beyond what international trade law (under TRIPS) requires: Each Party, says the draft U.S. proposal, shall confirm that: patents shall be available for any new forms, uses, or methods of using a known product; and a new form, use, or method of using a known product may satisfy the criteria for patentability, even if such invention does not result in the enhancement of the known efficacy of that product. This is the patent evergreening technique that Novartis tried to employ, which the Indian patent office rejected. Evergreening of a patent allows pharmaceutical companies to obtain or extend monopoly protection for old drugs simply by making minor modifications to existing formulae. The international organisation Medecins Sans Frontieres (Doctors Without Borders), which provides affordable health care around the world, points out: Evergreening significantly delays the arrival of more affordable generic medicines into the market. The TPP draft text further wants plants and animals and diagnostic, therapeutic and surgical methods for the treatment of humans or animals, which are explicitly ruled by TRIPS to be non-patentable, to be patentable.

In addition, another leaked document pertaining to the TPP seeks to eliminate the process of pre-grant opposition to a patent application, which is an important tool to prevent patent applications based on weak or erroneous information. The U.S. proposal, if accepted, would allow opposition only after the patent is granted.

Although this does not directly or immediately affect the Indian situation, it does portend ominous moves on this front by the U.S. on India as well. This is evident from the remarks Ron Kirk made recently: U.S. involvement in the TPP is predicated on the expansion of the agreement to include more economies in the Asia-Pacific region[and] should set the standard for 21st century trade agreements going forward.

It, therefore, stands to reason that the norms that emerge from the TPP negotiations will serve as the template for future U.S. trade agreements across the world. Using the leverage of the many countries in the TPP fold, and perhaps in other bilateral agreements, which accept this new enlarged premise for patentability, the WTO, too, eventually might come under pressure to change its rules of dispute settlement and arbitration. The implications of this are that IPR regimes, in particular the strict patentability criteria for drugs, of countries such as India, which have the responsibility of extending affordable health care to millions, will increasingly come under severe attack from the U.S. and the E.U., where nearly all the big drug multinationals operate and profit at the cost of the suffering poor of developing countries.

Question of efficacy

LEENA MENGHANEY cover-story

The country is clearly shaping its legislation to promote access to medicines by fostering generic production.

INDIA'S approach to the revision of its Patents Act in 2005 is a clear example of a country shaping its legislation to promote access to medicines by fostering generic production. Although World Trade Organisation (WTO) rules made it mandatory for India to put in place a patent regime for medicines by 2005, nothing obliges developing countries such as India to replicate the patent system of wealthy countries, which involves charging the highest possible price and protecting that price through patent monopolies that extend way beyond 20 years.

India has used important flexibilities under international law to include provisions in its domestic patent law not only to reduce the number of secondary patents but also to have a licensing mechanism that kicks in with excessive pricing of patented medicines. The application of these safeguards by the Indian patent office benefiting patients in India and other developing countries is increasingly inviting the ire of the multinational pharmaceutical industry and its associations.

The Indian government is faced with court cases and the diplomatic offensive that the protectors of the pharmaceutical industry in the United States and the European Union are now launching.

In India, the importance of generic (local) production of medicines in fostering competition and reducing prices was first recognised by lawmakers in the Patents Act of 1970, which brought in a legal regime that did not allow product patents on pharmaceuticals. In the following decades, India not only was successful in making drugs affordable but also significantly increased their availability by building domestic capacity to produce essential and life-saving drugs. It also went on to become the pharmacy of the developing world, supplying medicines to countries that lacked the capacity and resources to produce the drugs themselves or pay the high prices demanded by originator pharmaceutical companies.

The production of more affordable generic medicines in India has been instrumental in driving down the price of AIDS (acquired immune deficiency syndrome) medicines by 99 per cent, and nearly six million people living with HIV have been put on treatment on Indian generic medicines in the past 10 years.

In 2005, India was obliged to change its patent law in order to comply with its obligations as a member of the WTO, bringing into effect the TRIPS Agreement. The most significant change was the introduction of product patents for medicines. When framing the new patent legislation in 2005, Parliament sought to ensure that provisions to protect public health and access to medicines were incorporated into it. It, therefore, included explicit legal safeguards and guidance on how the patentability requirements should be applied.

In particular, evergreening, a well-known abuse of the patent system where companies seek new monopolies or, alternatively, extend a monopoly by seeking to patent minor changes such as new uses, new forms and other routine improvements of known medicines was addressed. Section 3(d) of the Indian Patents Act explicitly allows the broad exclusion from patentability of new uses and new forms of known medicines. In sum, Section 3(d) gave explicit guidance to the Indian patent office on how to weed out patent claims on routine improvements of known medicines and protect the country's capacity to act as a factory for the production and supply of affordable generic medicines.

Legal challenge

In 2006, in a landmark decision, the Indian patent office rejected Swiss pharmaceutical company Novartis' patent application for the life-saving anti-cancer drug imatinib mesylate. The application for a patent on a beta crystalline salt form of imatinib was rejected on the grounds that it lacked novelty, was obvious, and was un-patentable under Section 3(d) of the Patents Act. In retaliation, Novartis mounted a legal challenge to have Section 3(d) declared unconstitutional. Medecins Sans Frontieres (MSF) launched an international campaign calling on the company to drop the case, attracting close to half a million signatures. In 2007, the Madras High Court rejected Novartis' plea and in 2009 the Intellectual Property Appellate Board (IPAB) rejected its patent application on imatinib mesylate once again.

But the company is not backing down. After failing to have Section 3(d) struck down, it is now again seeking to limit its effect. In 2009, Novartis filed a special leave petition in the Supreme Court against India in relation to the patentability criteria to be applied to imatinib mesylate.

Under Section 3(d) of the Patents Act, new forms of already known substances cannot be patented if they fail to demonstrate the required degree of efficacy; it requires demonstration of increased efficacy for a medicine to deserve a patent. The interpretation of the definition of efficacy is therefore central to this case and to the future of India's role as the pharmacy of the developing world.

In 2007, in its constitutional challenge against Section 3(d) before the Madras High Court, Novartis had argued that increased bioavailability of the salt form of imatinib meant increased efficacy, entitling it to a patent. But the High Court clarified that efficacy meant therapeutic effect in healing a disease.

The IPAB, where appeals for unsuccessful patent applications are heard, subsequently applied this interpretation and held that the salt form of imatinib mesylate did not meet the test of therapeutic efficacy. It, therefore, confirmed the rejection of Novartis's patent application.

High standards crucial for tests in patent law

Setting high standards for the various tests in the patent legislation, particularly the efficacy test of Section 3(d) and the inventive step requirement, leading to fewer patents on new forms of known medicines, is important to safeguard access to affordable generic medicines from India. Novartis has now taken its case to the Supreme Court to argue against the interpretation of efficacy in Section 3(d) by the Madras High Court and the IPAB. This case has the potential to severely affect access to affordable essential medicines for millions of people across the developing world. It will determine whether Section 3(d) will continue to ensure that patents are granted only on medicines that are truly new and inventive. Many developing countries rely on affordable medicines produced in India, and such medicines constitute over 80 per cent of the AIDS drugs used in the developing world. MSF is closely following the outcome of this case.

Novartis is basing its claim for a patent on the salt of imatinib on the fact that there is a 30 per cent increase in the bioavailability of the drug in this new form. But, according to the guidelines for the examination of pharmaceutical patents developed by the World Health Organisation (WHO) and the International Centre for Trade and Sustainable Development (ICTSD), the selection of a salt of the active ingredient with the purpose to improve bioavailability is known in pharmaceutical science. It is common knowledge in the field that salts result in different solubility and, therefore, in different bioavailability.

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The final arguments in the case have started. The next date of hearing is set for July 10. If Novartis wins, many other medicines, even those that show no increased therapeutic efficacy, will be patentable in India, and the availability of affordable medicines will be threatened. If the substance is taken out of Section 3(d), abusive evergreening practices, where drug companies maintain artificially high prices on medicines well beyond the original patent period by securing fresh patents on minor modifications of existing drugs, will become rampant in the future.

If, on the other hand, the high threshold for patentability is upheld, generic production will continue to drive the price of life-saving medicines down. Multinational pharmaceutical companies such as Novartis will find it difficult to argue that routine improvements such as new forms of existing medicines that result in improved stability, enhanced bioavailability, increased solubility, improved flow properties and lower hygroscopicity meet the efficacy requirements of Section 3(d). In addition, the improved therapeutic efficacy would have to be supported with actual clinical data that demonstrate this effect.

The Supreme Court case is the final act in a legal battle that stretches back over six years between Novartis and the Indian government. The government, hopefully, will argue for a strict interpretation of efficacy so that patents on new forms of known medicines such as the one on the cancer drug imatinib mesylate are not granted as a matter of routine by the country's patent office. Novartis has lined up very senior and very expensive lawyers, including two former Solicitors General, to argue its case. But there appears to be no information on whether the government has appointed its own top lawyer, the Attorney General, in this case.

Opening the door for compulsory licensing

In another test case on access to treatment, seven years after India revised its 1970 Patents Act, the Controller General of Patents issued the first-ever compulsory licence (CL) to the Hyderabad-based company Natco to produce an affordable version of a patented anti-cancer medicine (sorafenib tosylate) of the German pharmaceutical company Bayer Corporation, marketed under the brand name of Nexavar. The generic version produced by Natco, which will pay 6 per cent royalty on net sales to Bayer, will be 97 per cent cheaper.

The decision was made on the basis of the fact that not only had the patentee, Bayer, failed to price sorafenib tosylate at a level that made it accessible and affordable but it was also unable to ensure that the medicine was available in sufficient and sustainable quantities within India. Bayer has time until mid-June to appeal against the order.

Like many other giant drug companies, Bayer defended the inflated cost of sorafenib by specifying the high spending on research and development. However, what it did not highlight was that the United States National Institutes of Health had sponsored almost 70 per cent of the second phase of its clinical trials. Later, this drug was given an orphan drug designation by the U.S.' Food and Drug Administration (FDA) for the treatment of renal cell carcinoma, entitling Bayer to 50 per cent tax credits, which further lowered the company's costs for the third and most expensive phase of clinical trials.

The CL is quickly being dubbed by pharmaceutical companies such as Novartis as a move that will stifle innovation. Indeed, pharmaceutical companies at present try to recover their investments by charging excessively high prices and protecting their drugs through patent monopolies. However, R&D costs are only a fraction of the profits thus made, and a large part of the profits are spent on brand-building and marketing. In 2011, Bayer spent nearly 9 billion on sales and advertising. In the same period, only 2.9 billion was spent on research.

The patent system also has another drawback. Innovation currently fails to address the needs of patients in developing countries.

The drug companies also repeatedly warn that measures such as the CL adversely affect the confidence of foreign investors. But a study published in Thailand in 2009 by the Health Intervention and Technology Assessment Program (HITAP) found little evidence of a link between the granting of CLs and the level of foreign direct investment (FDI) in the country.

The recently granted CL actually highlights a potentially new patent model that routinely allows low-cost alternatives in lieu of royalty payments, not only helping originators to recoup their development costs but also ensuring that people in developing countries have access to medicines. It is in line with licensing decisions in other jurisdictions. Recently, a U.S. court decided not to prevent a competitor from marketing a medical device used for skin grafts, and instead put in place a system of royalties from the competitor to the patent owner. At the core of this decision was the idea that the public has a right to access innovative health products and this should not be blocked by excessive prices.

The Novartis and Bayer cases highlight that the country is entering a new era in which disputes on the public's access to and the affordability of drugs will become more frequent.

Leena Menghaney is campaign coordinator of Medecins Sans Frontieres in India and is based in New Delhi.

Drug and duplicity

cover-story

NOVARTIS has long been suing the Government of India to eliminate or weaken Section 3(d) of the Patents (Amendment) Act, 2005, which established strict standards of patentability in order to prevent the ever-greening of patent monopolies on medicines. Although Novartis lost in 2007 its initial efforts to have Section 3(d) declared unconstitutional and violative of international norms for national patent regimes, it has persisted in appealing and re-appealing the denial of its patent application on Glivec, a key anti-cancer medicine whose basic ingredient was invented in 1993, well before India was required to begin granting patents on pharmaceutical products.

Novartis' latest appeal before the Supreme Court of India is scheduled to be heard in July. In that hearing, Novartis will ask the court to eviscerate the existing interpretation of Section 3(d), which limits patents on new forms and versions of existing chemical entities to those rare circumstances when such routine modifications result in a significant improvement in efficacy in terms of treatment of human illness. Novartis wants minor improvements in absorption or stability of the medicine to justify an additional 20-year monopoly.

In previous press statements, Novartis India has said that it is merely seeking clarity on the unique provisions of the Patents Act and that it is not trying to undermine lawful flexibilities in India or elsewhere with respect to the promotion of more affordable medicines. It has specifically said that it respects India's rights under international and domestic law to issue compulsory licences (permission to a generic competitor to make and sell an equivalent product). That was until India actually issued its first compulsory licence on Bayer's cancer medicine, sorafenib, on March 12. There, the Patent Controller ruled that Bayer had neglected to meet the reasonable requirements of the public, that it had charged an unreasonable price ($66,812 per patient a year!) and that it had not worked the product in India by means of any local manufacture.

Following the issuance of the Bayer compulsory licence, Novartis's publicity machinery changed its tune. On March 14, in The Times of India, Novartis' local representative in India, Ranjit Shahani, wrote: Compulsory licences are powerful rights granted to governments to deal with extraordinary circumstances such as a national health crisis and must hence be used with extreme prudence. As per TRIPS, WTO member states can grant a compulsory licence in case of national emergency, in case of public non-commercial use, in case of anti-competitive practices or in case of a dependent patent if additional criteria are met. If used injudiciously, compulsory licences will in fact work to the detriment of the patient through the negative impact they will have on future investment in innovative pharmaceuticals.

This statement grossly misstates the operative legal standards for compulsory licences under Article 31 of the World Trade Organisation's (WTO) TRIPS Agreement, but it helps to bring to light Novartis' real position on India's right to issue compulsory licences. Compulsory licences, as made clear both in Article 31 and in the Doha Declaration on the TRIPS Agreement and Public Health, are not limited to extraordinary circumstances, let alone to the narrow set of national emergencies, government use, anti-competitive remedies, or dependent patents listed by Shahani. WTO member states, including India, are free to determine any and all grounds upon which compulsory licences may be issued, with explicit acknowledgement that they may do so to promote public health and access to medicines for all.

India's issuance of a compulsory licence on Bayer's sorafenib was not injudicious. The Patent Controller's findings were detailed and fully weighed all of the arguments advanced by Bayer. In the end, however, the conclusion was easy pricing a medicine so that fewer than 200 cancer patients in India could access it, instead of the thousands who needed it, justified a licence to Natco, which could make and sell the same medicine at 3 per cent of the Bayer price while still making a profit and paying a 6 per cent royalty to Bayer. Health activists are hopeful that the sorafenib case will establish a strong precedent for more frequent compulsory licences on key HIV/AIDS, cancer, and psychiatric medicines, indeed, on medicines more generally.

Novartis's overzealous defence of intellectual property rights knows no bounds. It seeks to strengthen and lengthen patent monopolies and prevent the use of hard-fought flexibilities that ensure that poor people will not be left to die. Yet, it has issued pious statements in the past about its benign intentions with respect to the use of lawful TRIPS flexibilities. Now, the faade has been removed to reveal the naked greed that actually motivates Novartis' attack both on its lawful adoption of high standards for patents and on India's use of well-established flexibilities that have been recognised internationally for a century and a half.

Brook K. Baker

Professor Brook K. Baker is with Health GAP (Global Access Project), Northeastern University School of Law Program on Human Rights and the Global Economy, Boston. He is also Honorary Research Fellow, University of KwaZulu Natal, Durban, South Africa.

The current patent system is deeply flawed'

V. VENKATESAN cover-story

Interview with Shamnad Basheer, Intellectual Property Law Professor at NUJS.

PROFESSOR Shamnad Basheer joined the National University of Juridical Sciences (NUJS), Kolkata, in November 2008 as the first Ministry of Human Resource Development Chaired Professor in Intellectual Property Law. Before this, he was Frank H. Marks Visiting Associate Professor of Intellectual Property Law at the George Washington University law school and a research associate at the Oxford Intellectual Property Research Centre (OIPRC). He is the founder of several initiatives, including SpicyIP (one of India's leading intellectual property, or IP, blogs), IDIA (an initiative to foster access to legal education for the underprivileged) and P-PIL (an initiative to promote public interest lawyering through synergies between legal academia and the legal profession).

Basheer graduated from the National Law School of India University, Bangalore. He did his postgraduate studies at the University of Oxford, where he completed his BCL and M.Phil with distinction as a Wellcome Trust scholar. He was nominated recently as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF).

In this interview to Frontline, Basheer explains several issues of relevance to the drug prices in India. Excerpts:

In your written submission to the Supreme Court in the Novartis case, you have supported the Madras High Court's and the Intellectual Property Appellate Board's (IPAB) interpretation of Section 3(d) of the Indian Patents Act. Do you hold the view that its phraseology is correct? Critics have said that it is vague.

The Madras High Court was right in interpreting efficacy to mean therapeutic efficacy, but its reasoning on this front was rather peripheral and could have been stronger. It did not weigh in more significantly on this theme, since the issue of interpreting efficacy was never directly before the court. Rather, it was adjudicating a constitutional issue: was Section 3(d) so vague and ambiguous as to violate Article 14? The court, in this context, expressed some views on Section 3(d), which could arguably constitute obiter and not the real ratio.

In my intervention in the Supreme Court, I have tried to present stronger grounds for relying on therapeutic efficacy as the appropriate standard. I rely primarily on the structure of Section 3(d) as also its parliamentary history to support my interpretation. I note as below:

The structure of Section 3(d) as also its legislative history supports a narrow reading of the term efficacy'. Illustratively, the Explanation to Section 3(d) clearly states that all pharmaceutical derivatives would be considered the same substance', unless they differ significantly in properties with regard to efficacy'.

The above clause refers to only those properties that have some bearing on efficacy and not all properties. If all properties were to qualify, it would effectively render the term efficacy redundant. A statute cannot be interpreted in a manner as to render any of the terms in it redundant. Had Parliament intended any property to qualify under Section 3(d), the Explanation would simply have stated unless they differ significantly in properties. And the main part of Section 3(d) would have been rephrased as the mere discovery of a new form of a known substance which does not result in the enhancement of the known properties of that substance.

Therefore, not all advantageous properties of a new form (such as improved processability or flow characteristics, storage potential, etc.) ought to qualify under Section 3(d) but only those properties that have some bearing on efficacy.

Although this precise line of argument pointing to the phrase properties with regard to efficacy does not appear to have been explicitly made by either the Madras High Court or the IPAB to support their conclusion, it is one that compellingly supports a restrictive interpretation of the term efficacy.

This interpretation is further buttressed by the objectives of the Act, which suggest that Section 3(d) was introduced to prevent ever-greening.

Although the term evergreening does not have a scientific definition as yet, it is widely understood to mean an inappropriate extension in patent monopoly which does not convert to a significant benefit for the patient.

Put another way, it is a patenting strategy consisting of acquiring patents on minor, often trivial, modifications of existing pharmaceutical products or processes in order to indirectly extend the period of patent protection over previously patented compounds.

Do generic knock-offs stifle innovation by drug makers?

This issue essentially depends on the costs associated with bringing a new drug to the market. What is absolutely shocking is that despite the centrality of this question to debates around pharmaceutical innovation, we are still uncertain as to what the true cost of bringing a new drug to the market is. Drug majors have been extremely secretive about this in the past and the only study to have addressed this issue is a highly contested one. I deal with this issue partly in my recently completed PhD thesis and note:

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The most cited study in this regard (hereinafter DiMasi study) estimated that it would take approximately U.S. $802 million to produce a marketable drug. These estimates have increased, with the most recent figure amounting to approximately U.S. $1.3 billion. However, given that drug companies have been reluctant to disclose their costs of drug discovery and development to the public, these costs remain a highly contested issue.

In 2001, Public Citizen, a civil society group in the U.S., contested the above figures on several grounds, the most pertinent of which are highlighted below:

i) R&D costs should be regarded as an expense and not an investment. Therefore, the costs of capital are irrelevant.

ii) The estimated cost did not take into account the decrease in Food and Drug Administration (FDA) review time, lower clinical trial periods, and the contribution of new technologies such as genomics and combinatorial chemistry, which are believed to have assisted in the lowering of costs involved in creating drug leads.

iii) If one were to assume the veracity of the pharmaceutical industry's self-reported total R&D figures between 1994 and 2000 and divide this amount by the total number of approved drugs (after controlling for time lag), one would arrive at a figure of U.S. $108 million per new drug before tax benefits and U.S. $71 million after, which is significantly lower than what the DiMasi study cites.

Donald Light, Professor of comparative health care at the University of Medicine and Dentistry of New Jersey, United States, additionally critiques the study on the ground that the numbers are based on a small sample of large pharmaceutical firms which were non-randomly selected, and include only new molecular entities (hereinafter NME), the most costly sub-group of pharmaceuticals which constitute only one-third of new drug approvals. He argues that if the costs of other incremental drugs (constituting three-fourths of all drugs) were taken into account, the average cost of a drug would fall to U.S. $400. Light also offers several other correctives to argue in favour of a far lower cost estimate for clinical trials. First, the number of subjects involved in clinical trials as per FDA data was about one-third or less than those used by DiMasi, suggesting that the rest of the trials were done by firms to primarily bolster their marketing materials. Second, he cites data from the National Institutes of Health (NIH) indicating the costs per trial to be only a quarter of the figures used by DiMasi.

Importantly, the costs of R&D will differ from drug to drug, depending on the complexity of the science involved, the intensity of clinical trials, etc. The current patent system, which provides a uniform patent protection of 20 years to all new drugs, is, therefore, a deeply flawed one since it assumes that all drugs deserve equal protection. Further, many drugs also benefit from public funding and in any investment estimate this should be subtracted from overall costs.

In any case, without these figures, it is difficult to ascertain the worth of patent incentives and to what extent generic entry impacts these incentives. However, we do know three things:

that drug discovery and development require considerable investment (how much, we're not sure);

that the major drug companies invest primarily in drugs that have lucrative markets in the West. The amount of investment in developing countries or Third World diseases is appallingly low;

and that drug majors recoup almost all of their investments and profits from their main Western markets.

Would compulsory licences (CL) in favour of generics affect incentives to innovate?

Thus far, there is no empirical work demonstrating that licences stultify the rate of innovation. The few studies available indicate that licences do not have any significant demonstrable effect on the rate and pace of innovation. Illustratively, Colleen Chien empirically tests the rates of patenting and other measures of inventive activity before and after six compulsory licences over drug patents issued in the 1980s and 1990s. She observed no uniform decline in innovation by companies affected by compulsory licences and found very little evidence of a negative impact.

More importantly, one needs to ask whether all countries in the world need to contribute equally to Bayer's R&D efforts. Or whether countries such as India with significant numbers of poor patients can devise policies to induce lower-priced drugs in the market without worrying excessively about Bayer's incentives to innovate, given that such incentives are more than adequately provided by Western markets such as the U.S. and the European Union [E.U.]. After all, some of the biggest innovators today benefited from lax IP regimes in the past. Illustratively, Switzerland, which houses some of the world's leading drug originators, refused to introduce product patents until 1977, and it was only after considerable pressure and bullying from Germany that it finally yielded.

Lastly, it must be borne in mind that a compulsory licence is not an evisceration of the patent, as is sometimes made out to be in media reports. Rather, it embodies what Calabresi and Melamed, in their seminal piece, describe as a liability rule, where the patentee continues to hold the patent and is entitled to a reasonable royalty from every new player entering the market. This advantage (in terms of compensation through royalties) cannot be understated, particularly in a market like India, where the consumer market is highly differentiated in terms of purchasing power. Drug originators typically cater to very-high-income consumers, while generics are able to tap into middle- and low-income consumer segments as well. Consequently, the possibility of a new generic entrant entering a market segment hitherto untapped by the originator rather than simply displacing the patentee's existing customer base is high. To this extent, a compulsory licence may permit an innovator to profit from newer, untapped markets.

Is global supply of inexpensive medicines to treat acquired immune deficiency syndrome (AIDS), cancer and other diseases inconsistent with IP rights?

Cipla was the first company to sell AIDS medication at a fraction of the cost sold by drug innovators. Given that the rate of R&D and investments into HIV drugs has not slowed down significantly after that, one might hazard a guess that low-priced generics (albeit legal ones) do not necessarily impact innovation incentives.

India's strong generic pharma industry is attributed to the process patent regime introduced in the Patents Act, 1970. However, our obligation to implement the Agreement on TRIPS has forced us to reintroduce the product patent regime. Has this limited our ability to produce technologies through reverse engineering? Have our policymakers been able to exploit the flexibilities that exist in the framework provided by the agreement on TRIPS?

My own view is that India strategically exploited TRIPS' flexibilities to the hilt. It introduced higher standards for pharmaceutical patentability, a very potent opposition mechanism where any member of the public could effectively oppose a patent grant and some of the widest compulsory licensing norms that the world has ever known.

What, according to you, are the implications of Article 39.3 of the TRIPS Agreement requiring fixed period market exclusivity for the pioneer firms? Should India have to agree to comply with this Article and to the protection of test and other data submitted for obtaining marketing approval? Is there a way out?

Article 39.3 is loosely worded, leaving enough scope for India to continue rejecting data exclusivity as a norm. A good middle-path solution would, however, be a compensatory liability model, where data can be used by generics after the payment of appropriate remuneration (similar to the compulsory licensing model).

You have said that under Section 3(d), the applicant has to demonstrate a reasonable correlation between the efficacy claimed and the data provided in support of this. Such reasonable evidence of the correlation can be established by relying on, inter alia, statistically relevant data documenting the activity of the new form and/or known substance, documentary evidence (for example, articles in scientific journals), data generated using in vitro assays, or from testing in an animal model, other preclinical test data or any combination thereof. However, in 2007, the U.S. Supreme Court, in the KSR vs Teleflex case, cautioned against overemphasis on the importance of published articles. It argued that diversity of inventive pursuits and of modern technology counsels against limiting the analysis in this way. It pointed out that in many fields it may be that there is little discussion of obvious techniques or combinations, and it often may be the case that market demand, rather than scientific literature, will drive design trends.

KSR related to the standards for determining the obviousness of an invention for which the court suggested that even common sense would effectively do, rather than demonstrating the existence of some specific published article pointing to the allegedly inventive combination. It is a very different context and a very different theme from the present issue under consideration.

Essentially, my argument is that you cannot insist on proof by way of clinical trials under Section 3(d), since patents are filed at the discovery stage and clinical trials are conducted much later. More importantly, forcing patentees to compare known substances with their new discoveries through clinical trials in order to gain a patent may be unethical. Consider the Novartis case. Apparently, the imatinib free base (the previously known substance) cannot be used as a drug since it is not stable, etc. Therefore, it has to be converted to the salt form. Forcing human beings (clinical trial volunteers) to try an ineffective drug (the known imatinib free base) only to demonstrate that the new substance for which the patent has been claimed (beta crystalline form of imatinib mesylate) is more effective is unethical, to say the least.

You have said that efficacy ought to be interpreted to mean a definite therapeutic advantage. Can a patent examiner, who is not well trained in pharmaceuticals, pronounce on this convincingly? You have, for instance, refused to believe Novartis' claim that the beta crystalline form demonstrates a 30 per cent increase in bioavailability. You have said that this by itself does not demonstrate any therapeutic advantage in relation to the patient and that it has to be established independently. Can you elaborate how it can be done? But on the question of known substance, you have sought the appointment of an expert by the Supreme Court to make a determination. Are these not contradictory?

Bioavailability only means that the rate of dispersion of the drug through the body is faster. As to whether or not this speedier dispersion also impacts the speed of the cure is not known. Therefore, Novartis has to independently establish this if therapeutic efficacy is used as the standard.

The Supreme Court is free to appoint an expert to determine the issue of efficacy as well, but only after it has outlined the standard of efficacy (whether Section 3(d) means therapeutic efficacy or not). My focus has been on helping it evolve a standard in this regard. On the issue of known substance and novelty, etc, the legal position is established. Only the factual determination needs to be done which is why I'd asked for the appointment of an expert. Experts under the Patents Act can only be appointed for factual determinations and not for legal determinations.

You have described the IPAB's decision, which relies on excessive price of the drug as the ground for denying patent to Novartis, as a ludicrous legal proposition. But excessive price of the drug is a relevant factor in the grant of compulsory licence. Are these inconsistent? Some would say excessive pricing is a form of commercial exploitation of the invention, which according to you needs to be prevented. The alternative to compulsory licensing is riddled with many improbables.

A patent grant ought to be based primarily on technical criteria, that is, whether the invention has technological merit or not. Pricing, etc., come at a much later stage. At the stage of patenting, one may not even have a product to begin with. To me, denying patents on the basis of pricing concerns is simply bad policy. Further, such a provision may also contravene TRIPS.

Much like a knife, a patent can be put to either good or bad use. It makes sense to regulate the alleged abuse of a patent only after the grant (ex-post use). Such abuse of a patent in terms of pricing, etc., can be regulated through price controls and compulsory licensing. We've just had the first case now, so let us wait and watch to see if the CL policy works in helping us regulate excessive pricing by engendering more competition in the market. The first spate of pharma patents were granted only in 2006 or 2007. Under the Act, CL could be applied for only after three years from the date of grant effectively only from around 2010 or so therefore, there's been a real delay of around only two years or so in the grant of the first CL.

How many applications have been filed by generic manufacturers for the grant of a CL? Can you cite some prominent examples other than Bayer vs Natco?

Cipla has filed some CLs (for Isentress). Natco filed one for sunitinib last year (for export to Nepal). But their application was very faulty and was, therefore, dismissed.

Is the law on compulsory licensing unsatisfactory? Does it require any amendment to make it easier to grant?

It does give some scope for patentees to strategically delay the proceedings and frustrate the application. Such loopholes must be plugged.

Pre-grant opposition in patent proceedings has been criticised by some. Should India remove the relevant provision?

Not at all. Opposition is one of the most effective ways to ensure that the high standards under the Indian Patents Act are necessarily adhered to. Given that the Indian patent office is terribly understaffed and under-resourced, the likelihood of wrong decisions is high. An external source that can forward relevant prior art to the office (through an opposition mechanism) is useful for the process and for ensuring that the grant process is a stringent one.

The provisions relating to royalty to the patentee have also come in for criticism for being too vague. Your comments.

In the specific Bayer case, given that Bayer itself did not elucidate its cost and break-up, etc., to the Controller, he had nothing to go by. The easiest option was to pick a figure advocated by the UNDP, which he did. However, had Bayer submitted costs and break-up, it would have been far more difficult to simply apply a round figure that had no bearing on its cost of R&D (computed in proportion to the Indian market) and the paying capacity of Natco.

Perhaps, future cases would have to deal with this in a more elaborate manner. And, perhaps, the patent office might need to appoint economic experts as well to help with royalty computations.

Coming of age

JOHN CHERIAN world-affairs

Leaders of BRICS, who met in Delhi on March 29, take steps towards achieving the summit's goals: Global Stability, Security and Prosperity.

THE fourth Brazil, Russia, India, China and South Africa (BRICS) summit, held in New Delhi on March 29, once again saw the leaders of the five emerging world powers share a platform and articulate common views on many of the burning issues facing the international community. Only some sections of the Indian media, taking a cue from the Western media, are trying to play down the importance of the BRICS grouping. The gist of their argument is that four of the member countries have an unequal relationship with China, the grouping's biggest economic power that will, it is being predicted, outgrow the United States by 2020. Sceptics in India and elsewhere have kept on saying that the grouping will be dominated by China. But as the speeches of the leaders at the summit and the Delhi Declaration that followed illustrated, BRICS can provide a win-win scenario, as Chinese officials say, for all the member countries.

The BRICS leaders are taking steps towards the achievement of the stated goals of the summit: Global Stability, Security and Prosperity. The groundwork has now been laid to further deepen cooperation among the five countries, which have the bulk of the world's population and much of its resources. Prime Minister Manmohan Singh said that despite member countries differing on some global issues, there are many common interests that bind us all together. In his opening speech, Manmohan Singh advocated speedy reforms in global international financial and political institutions and urged the BRICS grouping to work together to overcome the challenges posed by the global economic downturn. BRICS, he said, should work towards adopting a common position on issues relating to climate change, food security and trade linkages. BRICS should also speak with one voice on important issues such as the reform of the United Nations Security Council, the Prime Minister urged.

President Hu Jintao of China stressed the importance of practical cooperation between the member countries, keeping the goal of common development and common prosperity in focus. Senior Chinese officials said that the priority was to ensure the continuity of global economic reforms. The other BRICS leaders agreed that reforms were essential for the growth of the world economy and for the achievement of sustainable global development. Chinese officials emphasised that their government was committed to cooperation with developing countries come rain or shine. China was the first to propose the need to strengthen economic cooperation among BRICS countries. Chinese officials have suggested that senior officials from the grouping, including Finance Ministers and central bank Governors, meet on a more regular basis.

President Dilma Roussef of Brazil described BRICS as one of the most important engines of the world economy, pointing out that the countries of the grouping would be accounting for 56 per cent of the economic growth forecast by the International Monetary Fund (IMF) for 2012. She, like the other BRICS leaders, blamed the developed world for the unjust growth policies that brought about the current global economic crisis. Brazilian Trade and Industry Minister Fernando Pimentel said his country wanted the summit's final communiqu to contain language that would be critical of the monetary policies being pursued by the U.S. and western European countries. Brazil accused rich countries of causing a monetary tsunami by introducing low interest rates and bond-buying programmes.

The Delhi Declaration adopted at the end of the summit announced that the member states were exploring the possibility of setting up a common development bank. The Finance Ministers of the five countries have been tasked by their leaders to come up with a feasibility study on the proposed South-South bank before the next BRICS summit, to be held in Russia. The leaders indicated that the bank would be a counterweight to institutions such as the World Bank and the IMF, which continue to be under the dominance of the West. They resolved to work in unison to pressure the West into making the World Bank and the IMF more accommodative to the needs of the developing world. There were discussions among the leaders to support a candidate from a developing country for the top post in the World Bank. The leaders stated that they wanted the heads of the IMF and the World Bank to be selected through an open and merit-based process.

The BRICS nations decided to invest more in the United Nations Conference on Trade and Development, which has been focussing on the needs of developing countries. The other priorities they outlined were the Doha Development Agenda of the World Trade Organisation and the Millennium Development Goals of the U.N.

The BRICS nations have also agreed to promote trade in local currencies in order to reduce their dependency on the U.S. dollar and protect themselves from its volatility. Trading in local currencies will be conducted only through state-owned banks. This agreement is aimed at reducing the importance of the dollar and could be interpreted as the first step to challenge its supremacy. Standard Bank, the largest bank in Africa, in a recent report predicted that $100 billion in Sino-African trade would be settled in renminbi by 2015. South Africa is already taking steps to replace the dollar as the preferred worldwide currency for trade and investments in developing countries.

Foreign policy issues

Importantly, for the first time in the short history of BRICS, foreign policy issues were dealt with at considerable length in the Delhi Declaration. The BRICS leaders recognised the vital importance that stability, peace and security of the Middle East [West Asia] and North Africa holds for all of us. On Syria, the declaration said that the crisis there should be solved through peaceful means that encourage national dialogues, which reflect the legitimate aspirations of all sections of Syrian society and respect the Syrian independence, territorial integrity and sovereignty.

Russian diplomats were unhappy with India's vote in the U.N. Security Council on Syria and the recent vote in the U.N. Human Rights Council on the human rights situation in Sri Lanka. They have been calling for a unified stand by BRICS on key foreign policy issues. A common position is needed on issues like Iran and Syria. The BRICS leaders should coordinate their positions at the summit, said Alexander Kadakin, Russia's Ambassador to India. He pointed out that the threats to Iran by the West had led to shocks to the oil market, which adversely affected the economies of many developing countries. Russia and China had made the grievous diplomatic error of supporting the Security Council Resolution on Libya last year, which gave the West a carte blanche for regime change in that country. India had abstained on the Libya resolution.

On Iran, the BRICS nations cautioned against the escalation of the crisis, stating that it would have disastrous consequences. The leaders acknowledged Iran's crucial role in a region of high political and economic relevance. At the same time, the BRICS declaration recognised Iran's right to peaceful uses of nuclear energy consistent with its international obligations. It called for resolution of the Iran issue through political and diplomatic means and dialogue. The statements pertaining to Syria and Iran are important signals to the West that the BRICS nations are slowly but surely formulating a common stance on key foreign policy issues. The leaders stressed the importance of adhering to international law while tackling regional problems.

The Delhi Declaration called for a speedy resolution of the Palestine issue, implicitly calling on Israel not to use the Arab Spring upheavals as a pretext for not engaging in meaningful talks with the Palestinians. The statement noted that the unresolved Palestinian issue was one of the main underlying causes for the instability in the Arab world. On the issue of a reformed Security Council, Russia and China, while not openly endorsing the candidature of the other three members, supported their desire to play a more meaningful role in the U.N.

The Indian government took a tough stance with Tibetan exile groups who had planned large-scale protests in Delhi to coincide with the Chinese President's visit. A serious incident that took place before the arrival of the BRICS leaders in Delhi was the self-immolation of a young Tibetan activist. Chinese officials said that they were saddened by the death. They recalled that India was among the first countries to recognise the Tibetan Autonomous Region as part of China. They also said that the border talks between the two countries were going on satisfactorily.

The Indian Prime Minister had a 60-minute meeting with the Chinese President. The two sides agreed that there was a need to improve communication channels to further strengthen the goodwill that exists between the countries and to reduce scope for misunderstanding. The two leaders identified West and Central Asia and Africa as areas on which they could hold dialogue on a regular basis. The two countries are engaged in the hydrocarbon and mineral sectors in these regions. There is a seeming undercurrent of rivalry between the two resource-hungry nations as they scramble for oil and influence in Africa and Asia.

Pope in Cuba

JOHN CHERIAN world-affairs

The Vatican seems keen to influence the politics of the country in the fond hope that it is on the cusp of radical change.

THERE was a great deal of pomp and fanfare during the visit of Pope Benedict XVI to Mexico and Cuba in late March. Both countries have a long history of being staunchly secular and keeping the Church out of the ambit of state activities. For the last eight years, Mexico has been ruled by the right-wing National Action Party (PAN), which has strong ties with the Catholic Church. The Institutional Revolutionary Party (PRI), which ruled the country for almost a century before that, had a strong anti-cleric bias. However, although the PRI is poised to come back to power, the party has made its peace with the Church, which has become much more visible in the daily life of the country. Mexico is overwhelmingly Catholic.

Cuba was officially an atheist nation until 1998. It made its peace with the Church after the historic visit in 1998 of Pope John Paul II. Since then, Cuba and the Vatican have enjoyed relations based on mutual respect.

A handful of dissidents spearheaded by a group called Ladies in White tried to hijack the Pope's visit to Cuba to further their cause. Cuba considers the small group of dissidents who are active on the island mercenaries in the pay of the government of the United States. Washington subsidises its activities. An American, Alan Gross, was arrested for supplying the dissidents with laptops. Ladies in White has been staging protest marches regularly after Sunday mass. The group had the tacit support of sections of the Catholic Church, but the Vatican was evidently warned that the Pope's trip would be jeopardised if he chose to encourage dissident groups openly on Cuban soil. The Pope announced beforehand that he had no intention of meeting political dissidents. The Vatican had said that the Pope would remain focussed on religious activities, which included the holding of open-air masses in Santiago de Cuba and Havana.

Two weeks before the scheduled visit, a group of 13 anti-government activists occupied the famous Church of Charity of Cobre in central Havana and demanded an audience with the Pope during his visit to discuss human rights issues and the release of political prisoners. The Cuban government had freed the last group of political prisoners last year after talks with the Catholic Church, when 75 anti-government activists, arrested in 2003, were allowed to go to Spain with their families. Most of those released are the husbands of members of Ladies in White. In December last year, President Raul Castro pardoned 2,900 prisoners who were jailed for petty crimes. The release of political prisoners and the pardoning of other prisoners were indirectly connected to the Pope's visit.

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Other dissident groups and the Church authorities were quick to condemn the move of dissidents to barricade themselves inside the famous church. The Church spokesman in Havana said that the protests were disrespectful not only to the Pope but also to ordinary Catholics who would have liked to pray peacefully in the church. Nobody has the right to turn temples into political trenches, he said. Nobody has the right to disturb the celebratory spirit of faithful Cubans and many other citizens who look with jubilation and hope towards the visit of the Holy Father to Cuba. A few other churches were also occupied by dissidents demanding an audience with the Pope. Finally, it was the Church and not the Cuban authorities that evicted the protesters before the arrival of the Pope.

The papal visit was meant to commemorate the 400th anniversary of the discovery of the statue of Our Lady of Cobre (Charity), the patron saint of the island. True to the Vatican's word, the Pope did not meet dissidents despite Berta Soler, the leader of Ladies in White, requesting one minute with him. During his three-day visit, the Pope also scrupulously avoided making statements that could be construed as critical by the government. The focus of his trip was to strengthen the Catholic Church and reconnect with his flock, the majority of them lapsed Christians.

The only solace the dissident groups in the island got was a quote from the Pope that questioned the relevance of Marxism. The Pope, who is a well-read man and has authored around 20 books on theology, in response to a question on board the papal plane heading for Mexico, said: Marxist ideology, as it was conceived, no longer responds to reality. In this fashion, it can no longer respond to the construction of a new society.

Critics of the Cuban government interpreted the statement as a direct criticism of its policies. Most Cubans, however, preferred to view the Pope's remarks in a constructive light. Cardinal Joseph Ratzinger, before becoming the Pope, was known for his conservative world view and his criticism of liberation theology, which had most of its adherents in Latin America. He was said to be behind the expulsion of priests sympathetic to the goals of liberation theology. Proponents of liberation theology describe Jesus Christ's teachings as being compatible with the goals of Marxism-Leninism.

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Cuba is witnessing dramatic changes in its political life as the government seeks to reinvigorate its socialist model of society. In this process, which requires patience but also decisiveness, we wish to help in a spirit of dialogue, to avoid traumas and to help achieve a fraternal and just society, the Pope told a journalist who had asked him about the relevance of socialism.

Like his predecessor John Paul, Pope Benedict, while in Cuba, was critical of the U.S.' economic blockade of the country. Such restrictive measures imposed from outside the country unfairly burden its people, he said in his last speech before leaving the island. The blockade, which has been in force since 1961, has had a debilitating impact on the Cuban economy and on day-to-day life. The Pope balanced his criticism of U.S. policies by calling on the Cuban government to introduce basic freedoms and relax its core ideological principles.

Cuba's Minister of Planning and Economy, Marino Murillo, was quick to emphasise that there would be no political reform in Cuba. Cubans are not willing to betray their revolution. They want the revolution to evolve further but within the parameters of socialism.

The Pope had a private audience with President Raul Castro. The meeting lasted for more than an hour and a half, much longer than the meetings the pontiff has with other heads of state. The Pope requested the President to declare Good Friday a national holiday. Pope John Paul, during his visit to Cuba, had requested Fidel Castro to declare Christmas a national holiday, which the Cuban government did. This time too the government acceded to the Vatican's request. For the first time, Good Friday was a national holiday in Cuba this year.

The current Pope, who is 84 years old, also had a very cordial meeting and exchange of ideas with Fidel Castro, who is a year older. Fidel Castro asked the Pope about the reforms he had introduced in the Church.

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The Pope's generally conciliatory tone in Cuba was also not liked in the U.S. The Barack Obama administration does not want the new reforms initiated by Raul Castro and currently being implemented in Cuba to succeed. If they do, Cuba will be able to remain independent and free from American domination.

The Pope also stated that the Church would always be with the simple faithful in Cuba. Although Cuba, like Mexico, is overwhelmingly Catholic, fewer than 10 per cent of the people regularly attend church. Many Cubans mix their Christian faith with traditional Yoruba beliefs, which their African ancestors brought from the west coast of Africa.

Cuba, Brazil and Mexico are the three countries in the region that have been selected for papal visits in the past 15 years. Brazil and Mexico are big countries with huge Catholic populations. Cuba is small, but the Vatican seems keen to influence the politics of the country in the fond hope that it is on the cusp of radical change.

Enduring presence

other

SIR Arthur Cotton, the British engineer who was the brains behind the barrage across the Godavari river near Doleswaram, has been a cult figure in the Godavari region for generations. Temples were built for the man who brought prosperity there and his statues adorn villages. His birthday is celebrated with reverence every year. The Godavari delta, spread over 10.3 lakh acres (one acre is 0.4 hectare) and coming under West Godavari and East Godavari districts, has become a launch pad for the Green Revolution.

The 150-year-old barrage built by Cotton was washed away by floods in 1986, and another bridge was constructed 45 metres upstream. The new barrage, with 175 vents, a prototype of Cotton's brainchild, provides a dead storage of 3 tmc ft and has an ayacut of 10.3 lakh acres spread across the two districts with assured water supply for two crops a year. The old barrage, with a dead storage of 1 tmc ft, was designed to provide water for only four to six lakh acres for a single crop.

The imposing structure has helped harness Godavari water for agriculture and aquaculture. The Godavari is considered a perennial river with inflows from a host of tributaries such as the Shabari, the Pranahita and the Penganga. The age-old canal and drainage systems designed by Cotton are all set to receive a facelift under a multi-crore modernisation project, which is under way. The drains and canals, which are in bad shape, have become vulnerable to breaches and floods, causing farmers heavy financial losses almost every year. The government has enforced a crop holiday in parts of the delta region in the current rabi season to accelerate the modernisation works. The project is expected to restore the past glory of the delta and save paddy fields from recurrent floods.

The West Godavari district has been undergoing a transformation from agriculture to agro-based industrial activity, with successive generations diversifying into aquaculture, rice milling and other industries after tasting success in paddy cultivation. Of late, lack of remunerative prices, increasing cost of production and soaring labour costs have resulted in distress to the farming community. Evidence of the agrarian crisis manifests in the form of crop holidays in parts of West Godavari district and in the Konaseema region of East Godavari district.

The West Godavari district administration is sparing no effort to bail out agriculture and to protect sharecroppers, who cultivate more than 80 per cent of the agricultural fields. Making bank credit available to a large chunk of tenant farmers through a loan eligibility card (LEC) scheme is the administration's major initiative to address the problem of distress.

Collector G. Vani Mohan asserts that the farmer-induced crop holiday was limited to some extent in West Godavari district because of the LEC initiatives.

G. Nagaraja

Social security

other

EVER since the economy was liberalised in 1991, the working class has been at the receiving end be it in the matter of jobs or social security (Unkind cut, April 20).

EPF has seen a steep fall in interest rates from the initial 12 per cent. The government has turned a deaf ear to the request of Left parties and trade unions to enhance the wage ceiling of Rs.6,500 for EPF, and increase the interest rate. Many employers do not provide the EPF facility to their staff claiming that they pay a salary of Rs.6,500 or more. Only about 4.7 per cent of our population have EPF cover. The government, which refuses to give a decent interest rate to workers, offers many subsidies, tax holidays, exemption from certain labour laws to big industrialists.

Such practices can lead to political unrest. G. Anuplal Bangalore Linking rivers

THE river interlinking project is too big to be successfully executed in a country like India (Mission Impossible, Cover Story, April 20). There are too many hurdles in the way huge costs, land acquisition issues, displacement of millions of people, and so on.

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The big question is whether the government will take such an anti-people stand. When the National Highways Development Project entailing lesser costs could not achieve the desired results, how can the government achieve success with an ultra-mega project such as ILR. And if past records are anything to go buy, such projects result in huge corruption.

Bal Govind Noida

THE problem of water deficit can be solved by rainwater management and economical usage of water. The water quality of one river is different from that of another. Interlinking rivers cause severe damage to biodiversity.

Dr Hem Srivastava Ranchi, Jharkhand

THE Cover Story was very informative. It helped the lay reader understand the reasons behind the delay in the project's execution.

Sujit Ugale Nasik, Maharashtra

WHEN Justice B.N. Kirpal proposed the interlinking of rivers in 2002, he said that it was just a recommendation. But the latest in the string of judgments on this issue does not open even a small window for debate and discussion. Interlinking of rivers is a highly technical matter that needs to be debated by a panel of philanthropists, social scientists, engineers, and so on. It is not something that can be decided by a Bench of judges alone. The Supreme Court has also not taken into consideration any literature on the subject other than the NCAER report.

It has to be seen if the Ministry of Environment and Forests will give the go-ahead for this bizarre project, considering its environmental implications. How can the country even think of embarking upon this project when States are yet to settle river water disputes?

Ritvik Chaturvedi New Delhi

THE Supreme Court has thrown its weight behind a decade-old project, which is being opposed by some States, environmentalists and social activists. In fact, interlinking the country's river system to transfer surplus water to deficit areas through a network of canals was first conceived by the visionary engineer K.L. Rao, who had served in the Cabinets of Jawaharlal Nehru, Lal Bahadur Shastri and Indira Gandhi.

Of India's annual surface water resource of 69,000 tmcft, only 8,800 tmcft is utilised. The rest drains into the sea. Interlinking rivers would help generate more than 40,000 MW of clean and green electricity.

K.S. Jayatheertha Bangalore

INTERLINKING India's rivers is not feasible. Ever since former President A.P.J. Abdul Kalam highlighted the need for such a project and former Prime Minister A.B. Vajpayee popularised it, people began to dream that the nation would be relieved of the problems of floods and droughts and be able to also increase foodgrain production. What they did not realise was that the government announces many plans just to fascinate people and win elections.

Sushil Kumar Aurangabad, Bihar Provident Fund

UNLIKE deposits in banks and other financial institutions, the Employees' Provident Fund is a social security measure (Unkind cut, April 20).

Keeping the interest of workers in mind, the fund was introduced soon after Independence through an Act of Parliament. The employees' money remains with the government during their long periods of service. Since the government invests EPF funds in development schemes, they deserve a higher rate of interest than the usual fixed deposits. The government has hiked the interest rates on post-office small-savings plans by up to 50 basis points for the new fiscal year. In view of the social security of employees, especially in old age, the government must restore the 9.5 per cent interest rate on EPF.

J.S. Acharya Hyderabad

BY reducing the EPF rate to 8.25 per cent, the Union Finance Ministry has dealt a severe blow. It has broken the morale of the poor non-government employees. The Labour Ministry's silence over the issue is intriguing. Hopefully, the Finance Ministry will revoke the notification.

Jayant Mukherjee Kolkata Nuclear power

THE Tamil Nadu government's consent for the immediate commissioning of the Kudankulam nuclear power project in Tirunelveli should be respected and welcomed by all (Full steam ahead, April 20). Unnecessary criticism and protests against industrial projects should not be allowed to ruin the growth of the country. Everyone has a right to protest against any project, but there should be no place for false propaganda. As poet Rabindranath Tagore said, Science has given man immense power. The golden age will return when it is used in the service of humanity.

P. Senthil Saravana Durai Vazhavallan, T. N.

AS long as politicians are not ready to discard parochialism, stage-managed agitations are bound to happen. In Kudankulam, vested interests have exploited the sentiments of the local people. More than the threat of nuclear leak or radiation, what worries some people is the round-the-clock presence of Central security forces in the Kudankulam belt, which will deter the unlawful activities that have been going on in coastal areas around the project site for years together with the blessings of some influential people.

Instead of invoking NSA in September 2011 itself, the Centre chose to remain a mute spectator and unnecessarily allowed the issue to escalate beyond control. This helped the State government to take control of the situation on the grounds that law and order is a State subject.

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The agitation exemplifies the rising clout of States against a weakening Centre, which does not augur well for the federal polity.

Ettirankandath Krishandas Kinassery, Kerala Sri Lanka

INDIA made a wrong diplomatic move by voting in favour of the U.S.-backed resolution at the UNHRC against Sri Lanka (Lessons leant?, April 20). This distortion of India's foreign policy at the behest of the DMK may backfire.

The U.S. has often described India as a Muslim-baiter, citing the Babri Masjid issue. We have unwittingly toed the American line. The country has the habit of bullying its friends and respecting its opponents.

India should have adopted a non-interference policy in the Sri Lankan Tamil issue. If we supported Sri Lankan Tamils to appease the Tamil politicians, then we should concede Pakistan's right to help the Muslims of India. The LTTE was more cruel than the Sri Lankan army personnel. It mercilessly killed former Indian Prime Minister Rajiv Gandhi and many Sinhalese leaders as well as Sri lankan Tamil leaders of moderate groups.

The U.S. backed the resolution not out of any sympathy for Sri Lankan Tamils but out of its need to stop Sri Lanka's efforts to move closer to China. The U.S. also wants to get a foothold in Sri Lanka.

S. Raghunatha Prabhu Thiruvampady, Kerala Vodafone case

MOST review petitions are dismissed by the Supreme Court without assigning any reason, although many of them indeed have valid legal points (A new look at capital gains, Update, April 20). The government may get the better of flawed' court orders by amending the law, but what option is left with the ordinary citizen? The review petitions should be heard by a different Bench in the interest of justice.

Satish Kumar Gajbhiye Nagpur Sachin's century

LIKE Donald Bradman's Test average of 99.94, Tendulkar's record of 100 centuries in Test and one-day internationals might never be broken. (Tons of passion, April 20). We must enjoy his twilight years because there might not be another Tendulkar in the foreseeable future.

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AFTER an agonising wait of 12 months, Sachin finally reached the milestone of scoring a century of centuries. It is a moment of pride for every Indian. We salute the little master for this phenomenal feat and for giving us some extraordinary moments in cricket.

K.R. Srinivasan Secunderabad

ON his 100th hundred, Sachin said that after achieving it he was really thrilled and looked at the dressing room and pointed my bat to the players and also to the Indian flag that I have on my helmet. This statement reveals his love for the country and his sense of camaraderie with his teammates.

N.C. Sreedharan Pallikunnu, Kerala

SACHIN admits that the obsession of others had made his hundredth century very difficult to score. The fact that he scored it against one of the weakest sides in the world did not diminish its significance.

P. Arihanth Secunderabad

THERE have been many Indian cricketers who had passion, hunger and motivation, yet were prematurely and unceremoniously retired or rested during the peak of their careers from different formats of the game. The list is long Anil Kumble, Sourav Ganguly and Rahul Dravid, to name a few. The current IPL series confirms that they still have spark in them.

Sadly, things have boiled down to Let Sachin play for the sake of individual records in a team game, and the rest for the nation. Any other player taking 14 innings to score his first Test century, 76 to score his first ODI century and 33 to go from the 99th to the 100th century, would have been dumped. Sachin could reach this number only because of the selectors' benevolence. In fact, Sachin had equalled Sri Lanka's Aravinda de Silva's world record of appearing in the maximum number of lost matches (163) in 2006 itself.

Varin Dhir Ahmedabad, gujarat

IT is sad that Tendulkar did not come for Dravid's farewell function organised by the BCCI in Bangalore and that Dravid did not attend the felicitation of Tendulkar in Mumbai.

Dravid, who voluntarily quit Test cricket but is ably captaining Rajasthan Royals, and Tendulkar, who does not want to call it a day from first-class cricket and continues to play for Mumbai Indians in IPL-5, are two of India's all-time greats.

S.V. Venkatesh Bangalore Norway

THE column Dangerous Altruism amplifies the concerns expressed through the ongoing shrill public debate on the Bhattacharya children in Norway (April 20). There is an old saying that if you save a life, you remain responsible for that life forever. That premise guides the global child protection plan, which began to be constructed in South Asia in the immediate aftermath of Partition.

In the incredibly more complicated case of Rahat Ara and her children, Prime Minister Jawaharlal Nehru had suggested steps to be followed before handing over children but also made it clear that the state was not and could not be a substitute for a family. Before we decide anything, I should like you to write to our Deputy High Commissioner, . Ask him to make discreet enquiries about these people, Tell him we want to have as much information as possible so as to enable us to decide. We should look at this question from the human point of view. If both the father and mother want these children, I see no justification to keep them here. We may look after them well now, but how can we guarantee any future for them.

Norway, as every other country which has signed the Convention on the Rights of the Child, is duty-bound to protect every child who comes into its care. We now know there are flaws in the way its system operates.

The question that remains unasked is why the Indian Embassy, which is duty-bound to support all Indian nationals, both adults and children, in their time of need, came into the picture only after the President of India called the External Affairs Minister of India, who then called the Norwegian Foreign Minister, to request the return of the children to their family.

If the Norwegian authorities did not do their jobs well, neither did the Indians. We have a family torn, children disconnected from their parents and the relationship between two countries stressed. No one comes out a winner in this.

Vijayalakshmi Balakrishnan New Delhi Fukushima

PRAFUL BIDWAI has said that the world must embrace another energy paradigm (End of an illusion, April 6). But until viable alternatives emerge, developing countries should not abandon the existing energy paradigm. After all, 400 million people in our country do not have access to electricity even today.

Bidwai's conclusion that the Fukushima accident was the most serious ever cannot be accepted. According to AEC Chairman Srikumar Banerjee, not one person died or was affected by radioactivity on account of any nuclear blast in Fukushima. Only a hydrogen blast had taken place owing to coolant failure. It was the combination of a tsunami and an earthquake that claimed thousands of lives in Japan.

K. Ravindran Goundampalayam, T.N. ANNOUNCEMENT

Letters, whether by surface mail or e-mail, must carry the full postal address and the full name, or the name with initials.

Semblance of justice

other

VERDICTS were delivered in April in two cases relating to the communal riots in Gujarat in 2002. A Special Court in Anand district convicted 23 persons for burning to death 23 people in a house in Ode near Anand. Eighteen of them were given life terms. However, in the second case, known as the Gulberg Society case, which relates to the killing of 69 people, the victims of the violence suffered a setback when the Supreme Court-appointed Special Investigation Team (SIT) filed a closure report in the court. The difference between the two cases is that Chief Minister Narendra Modi is accused number one in the latter, filed by Zakia Jafri, widow of former Member of Parliament Ehsan Jafri, who was one of the riot victims.

Does the closure report mean that it is curtains for the Zakia Jafri case and that Modi has finally got a clean chit? For the short term yes, say activists. Zakia Jafri will continue her battle for justice. The judicial process allows her to contest the closure report and take the case up to the Supreme Court.

There are nine cases relating to the riots that broke out in Gujarat after the Sabarmati Express carnage in Godhra on February 27, 2002. Most of them have reached the final stage, and verdicts will be delivered in the coming months. The first semblance of justice came last November in the Sardarpura massacre case in which 31 accused were given life terms for burning alive 33 Muslims.

Obviously, the verdicts do not bode well for the Chief Minister, when the State is heading for Assembly elections later this year. Besides, Modi has been using every opportunity to project himself as the next national leader from the beleaguered Bharatiya Janata Party (BJP). He has been trying hard to shake off the the-man-behind-the-riots label, but he has not been very lucky.

In the Gulberg Society case, Modi and 61 other top politicians, administrators and police officials are accused of being responsible for the attack on the colony.

While pronouncing the judgment, the Ahmedabad Metropolitan Magistrate said the SIT had not found any evidence to prosecute the Chief Minister, top bureaucrats and senior police officers and recommended that the investigation in the case be closed.

According to the SIT, no offence has been established against any of the persons listed in Ms. Jafri's complaint. Therefore, as per the Supreme Court's order and the principle of natural justice, the complainant has to be given a copy of the report and related documents, the court said.

A disappointed but determined Tanvir Jafri, son of Ehsan Jafri, told mediapersons: The SIT says there is no evidence against Mr Modi, but not the court. The SIT's decision is of no value if the magistrate decides against it. It may take time, but we are going to fight it out.

Activist Teesta Setalvad of the Citizens for Justice and Peace (CJP), who has stood by the Jafris in their legal battle, says the amicus curiae report is not out yet and that report will be crucial to the case.

The SIT chief, R.K. Raghavan, was measured in his response to the court order. The CJP and other activist organisations have repeatedly accused the SIT of not taking into account all the evidence presented. They charge that the probe was handled badly, and cite the fact that two officers, Geeta Johri and Shivananda Jha, were removed from the SIT for shoddy work.

Raghavan said that the SIT did a good job and that closure had been recommended in the Gulberg massacre case as the team could not find any evidence against the people named in the petition. He said: We have filed the report saying no evidence on the contents of a particular petition was available and recommended closure.

Ode to justice

Ode, a small town near Anand, witnessed the gruesome massacre on March 1, 2002. Many of the 23 people burnt alive in a house were women and children. The case was one part of the nine that the SIT probed.

On April 9 this year, the Ode case became the second in the nine to see justice delivered. The prosecution had demanded the death sentence for 18 of the 23 persons convicted for murder and criminal conspiracy. It is a heinous case involving mass killings of women and children, so the trial court should award capital punishment to the convicts, Special Public Prosecutor P.N. Parmar said. The trial, which began in November 2009, saw 158 witnesses being examined.

The Ode and Sardarpura cases raise the hope that the Gulberg case will also see justice eventually.

Anupama Katakam

Battle of Bastar

Chhattisgarh: The Centre approves the diversion of forest land for the Tatas' proposed steel plant in Bastar.

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INDIA'S hinterland, densely forested and mineral-rich but inhabited by extremely poor and vulnerable tribal people, is witnessing a saga of broken promises, dislocation, deprivation and disempowerment in the name of development. Whether it is Niyamgiri in Odisha, Jharsuguda in Jharkhand, or any other place in India, tribal people are up in arms against policies that seek to dislodge them from their homes and their land. The Bastar region of Chhattisgarh is the latest on the list. After some delay, Tata Steel recently got the Centre's approval to divert a huge tract of forest land for its greenfield mega steel plant at Lohandiguda in Jagdalpur in the region. Work on the project may begin any time. Villagers, who face eviction, were unaware of the development until this correspondent broke the news to them. The immediate reaction was disbelief followed by despair. Many residents of the villages in Lohandiguda block, which will be affected by the project, said they would die fighting rather than part with their land.

The Chhattisgarh government signed a memorandum of understanding (MoU) with Tata Steel in 2005 for the greenfield project with a capacity to produce 5.5 million tonnes steel a year, on an investment of Rs.19,500 crore. The project envisages the acquisition of over 2,000 hectares of land. The area required for the steel plant is some 960 ha; the rest of the land will be used for residential quarters, ancillary units, roads, schools, hospitals, and a 625 MW captive power plant. About 585 ha earmarked for the project is held by individuals (called account holders, or khatadharaks in Hindi). The rest is controlled by the government and can be allotted directly to the Tatas on lease.

The controversy is about the agricultural land belonging to the 1,707 account holders. The local administration says 80 per cent of this land has been acquired, while Tata officials say that the entire compensation money has been deposited with the administration for the purpose of acquisition.

The company and the local administration organised a public hearing on the environmental impact assessment (EIA) for the project on October 12, 2009, at the proposed project site in Lohandiguda, and it was attended by Varun Jha, Tata Steel vice-president in charge of the project. At that meeting, company officials promised to invest Rs.2,000 crore for environmental protection and conservation as per rules, but no other details of any restoration plan were offered.

A year later, on October 12, 2010, the District Collector organised a public hearing on the Collectorate premises to sound out the villagers over the project, and later declared that the project had received overwhelming support from the villagers. The villagers, however, claim that both meetings were stage-managed and persons who would be actually affected were prevented from attending them. Those who attended, they allege, were people from Jagdalpur, contractors, real estate agents and others with vested interests. The villagers, in fact, organised a parallel public hearing in November 2009 at Badanjee village, where the project was unanimously shot down. They sent copies of the minutes to the then Minister for Environment and Forests, Jairam Ramesh.

There was no response to their complaint, and on October 22, 2010, the Environment Ministry gave clearance to the project; this clearance said that work could begin only after the Union government gave approval for the diversion of forest land. This approval was granted in March this year.

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Some 20,000 people in 10 villages will be affected by the project. Nine of the villages are in Lohandiguda block Badanjee, Belar, Takraguda, Kumhali, Chindgaon, Dhuragaon, Dabpal, Paroda and Beliapal. The tenth, Sirisguda, is in Tokapal block.

The villagers say they have been petitioning the governments at the Centre and in the State, pointing out that no worthwhile social impact assessment was done for the project and not enough measures to mitigate environmental pollution were promised. They allege that not only have their pleas gone unheeded but they have also been facing harassment at the hands of the police. Slapping of false cases and even award of jail terms on the basis of these are some of the ways in which the administration has been trying to bully them into falling in line, the villagers say. According to a list drawn up by them, 100 villagers have been booked under false charges and are still being terrorised by the local administration. In some cases, indirect pressure is applied through family members.

Hirmoram Mandavi, a farmer and the sarpanch of Takraguda village, said: They cannot scare us into giving away our land. No matter what the compensation, we will not give our land. Let them first kill us, but before they do that we will kill them as well. Fellow villagers Ramu Ram Maurya, an activist of the Communist Party of India (Marxist), Madhusudan Bhakra, the sarpanch of Badanjee village, Kamal Gajviye, a resident of Kumhali village, and many others echoed his thoughts. Mandavi said that the villagers had been forced to give their signatures approving the project at a stage-managed gram sabha meeting where they were terrorised by heavy police deployment. He added that it was only the local administration's claim that the villagers had given their approval for the project.

They were initially promised Rs.3.75 lakh to Rs.5 lakh a hectare, and the administration has promised to ensure that they get Rs.25 lakh a hectare. But, Mandavi said, the tribal people would not give up their land, whatever the price. We do not know what to do with money, but even a small patch of land will ensure that we have something to eat, he said. According to Gajviye, even if one member of each family is assured a job in the project, it is of no real value since the tribal people, with their lack of skills, will get only the lowest-paid jobs.

The Congress is backing the State's Bharatiya Janata Party government on the issue. The villagers, backed by the Communist Party of India (CPI), have approached the authorities at all levels and are even willing to undertake a fast unto death to stop the project. Even if we have to give up our lives, we will do that, says Bhakra.

The villagers are all the more annoyed because the MoU did not mention Lohandiguda block at all and had only Tokapal block as the target area. The land in Lohandiguda is very fertile, it gives us two crops a year as it is near the source of water. Why can't the government ask the Tatas to take banjar [barren] land? Why take away our agricultural land? one of the villagers said, echoing the general sentiment.

The reply to this, interestingly, comes from the Collector of Jagdalpur, Angalban P. According to him, the land in Tokapal, which was initially earmarked for the project, was subsequently found to have a high potential for diamond mining, and reconnaissance work for it is going on. Suppose we give away the land to Tatas and tomorrow diamond mines are found on that land, then what do we do? We cannot take that risk, he says.

But how wise is it to destroy large chunks of agricultural land and wipe out forests, and thus wreak havoc on the ecology? According to the Collector, despite the collateral damage, the returns are high. The fertility here is not very high and the project will bring in many related economic activities as a result of auxiliary and ancillary units coming up, which will benefit the villagers. The profile of this area will be transformed and it will become one of the richest townships, like Bhilai or Jamshedpur, he said.

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He conceded that the administration had not dealt with the villagers with tact. Yes, I agree that initially there was high-handedness, and unnecessary force was applied on the villagers. They should have been dealt with with more sensitivity, and I plan to do just that. I will try and make them understand that the project is for their own good, that they cannot live in isolation and poverty under the excuse of their exclusivist culture and tradition. After all, the mineral wealth of the region on its own will not do any good for them if it is allowed to be carted away to other areas, as it is happening now. But if the project is set up, they will benefit in many ways. We will make schools for their children, will make hospitals; they will be given jobs and provided training to equip themselves for better jobs. We will have one of the best rehabilitation schemes for them, he said.

The administration is willing to give land for land in as many cases as possible and give more than Rs.25 lakh a hectare as compensation. He says more than 50 per cent of the landholders have taken the compensation. Even their compensation amount will be enhanced, if there is a need, he said.

The villagers dismiss all this as bunkum. In Jamshedpur, go and see for yourself. How many tribal people and their children have been given jobs? All this is just an eyewash, a ploy to usurp our land for the big companies, to destroy Bastar, to destroy our forests, says Gajviye, declaring to an accompanying chorus that if the government tries to use force, it will be worse than Singur.

The local administration seems to have realised that violence and strong-arm tactics will not work. There is no question of any violence. Yes, we want the project here, but only if the villagers agree. We are not desperate at all, the Collector said.

But Tata Steel has already paid the entire compensation amount, Rs.69.43 crore, to the Chhattisgarh State Industrial Development Corporation for the land which has been acquired by the State for them. We certainly want to start work on the project as soon as we can since all the clearances, including the one for diversion of forest land, have come. But we certainly want to keep this project as low profile as possible, otherwise it will invite trouble, said a senior Tata Steel official.

So the conciliatory approach may not last. Roughly 70 per cent of this money has been disbursed, according to the administration, while Rs.27.36 crore is still lying with the Collector. The money that has been disbursed has been deposited in the bank accounts held by the account holders, or khatadharaks. Some villagers seem to have accepted the compensation under pressure.

The project is almost certain to destroy the lush green forests of Bastar and change the way of life of the tribal people of the area. Trees on 42 ha of forest area will be cut down. The tribal population of the region depends on the forests for minor forest produce, such as tendu leaves, mahua, tamarind and timber. Farming and the collection of such produce are the only economic activities that the tribal people of the region engage in. There are no details forthcoming on any relocation plans, so it is not clear to what extent the project-affected people may be rehabilitated. Besides, the region's groundwater and the waters of the Sabari and Indravati rivers, the main sources of drinking water for the tribal population, will get polluted, affecting agricultural activity in nearby areas. The movement of heavy vehicles, transportation of iron ore from the mines to the plant, and the 625 MW captive power plant will add to the pressure on the environment.

Posco in limbo

The National Green Tribunal's decision to suspend the environmental clearance given to Posco vindicates the project's critics.

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ON March 30, the Principal Bench of the newly formed National Green Tribunal (NGT) delivered a momentous decision suspending the environmental clearance (EC) given to the South Korean transnational corporation, Posco, to set up an integrated steel plant at Paradip in Odisha's Jagatsinghpur district. The former Union Minister for Environment and Forests, Jairam Ramesh (currently Union Minister for Rural Development), had granted the EC on January 31 last year (Final Push, Frontline, June 3, 2011).

The NGT Bench, comprising Dr Devendra Kumar Agrawal (Expert Member) and Justice C.V. Ramulu (Judicial Member), directed the Ministry of Environment and Forests (MoEF) to make a fresh review of the project by engaging specialists for a better appreciation of environmental issues.

The Odisha government and Posco signed a memorandum of understanding (MoU) on June 22, 2005, to set up the steel plant, with a total capacity of 12 million tonnes per annum (MTPA), with four million tonnes in the first phase. The project includes a captive power plant and a captive minor' port. (It was masqueraded as a minor port' in order to evade the stringent review demanded for major ports, according to critics.)

The project requires about 1,621 hectares of land, of which about 1,253 hectares is forest land. In addition to this, over 2,440 ha of the thickly forested land in the Kandadhar hills in the Sundergarh district of Odisha has been identified for a captive iron ore mine for the project. Posco, according to the MoU, can extract 600 million tonnes of high-quality iron ore over a 30-year lease period, 60 per cent of which could be exported without processing. A rider in the MoU that such export will have to be in tandem with an equivalent import of similar quality of iron ore does not make any sense at all.

With an initial capital outlay of Rs.51,000 crore ($12 billion at 2005 prices), this is India's single largest foreign direct investment ever.

The MoU, according to independent observers, effectively protected Posco from all business risks and aimed to facilitate its international growth and expansion plans and its unprecedented profit-making venture.

Despite these obvious flaws in the MoU, the then Minister for Environment, A. Raja, gave clearance to the minor' port for the steel project on May 15, 2007, a day before he was supposed to hand over charge of the Ministry. Raja also granted the Coastal Regulation Zone (CRZ) clearance for the project on the same day. (Raja subsequently became the Telecom Minister and had to resign following the expose of the 2G scam.)

On July 19, 2007, the MoEF granted EC to the plant. Ironically, this original EC survives, even though the NGT has suspended the final EC granted by Jairam Ramesh last year. Jairam Ramesh accorded final sanction after imposing 28 conditions over and above those stipulated in the original EC. He also accorded EC for the captive minor port, with 32 conditions over and above those stipulated in the original EC granted by Raja.

The NGT's reason for leaving the 2007 EC untouched is that it was hopelessly time-barred. The NGT Act, 2010, came into force with effect from October 18, 2010, and therefore, the NGT took the view that only those orders passed on or after the commencement of the Act could be challenged. The 2007 EC is valid only for five years, and it would require an extension, with fresh conditions that the new review committee to be set up by the MoEF may impose.

The final clearance

Jairam Ramesh accorded the final EC after the submission of the review report by a four-member expert committee. This committee comprised Meena Gupta, the chairperson, and three other members. As there was no consensus, the committee submitted two reports to Jairam Ramesh, one by Meena Gupta and the other by the remaining three members, on October 18, 2010. The three members were a former Director General of Forests, Devendra Pandey, the civil rights lawyer V. Suresh, and the tribal affairs expert Urmila Pingle. While Meena Gupta favoured the grant of EC, the other three members opposed it. Jairam Ramesh accepted Meena Gupta's report, and this invited much criticism. The appellants before the NGT, Prafulla Samantray and Biranchi Samantray, both activists opposing the Posco project, argued that Meena Gupta was the Secretary of the MoEF at the time of grant of the original EC, and therefore, Jairam Ramesh ought not to have included her in the committee for reviewing the original EC as she was a party to it.

The NGT found Meena Gupta's report a balanced one, but added that there was a clear bias to defend her previous acts as Secretary, MoEF. Her argument was that since the ECs had already been granted, there was no need to go into all the details except suggesting additional precautionary measures. The NGT added: Whether the act of Ms. Meena Gupta is fair or not, they are definitely hit by personal/official/departmental bias; in other words, she supported the decision made by her earlier. This is in gross violation of principles of natural justice. Therefore, the entire process of review is vitiated under the law.

The NGT then added: However, we have kept in mind the need for industrial development, employment opportunities created by such projects that involve huge foreign investment, but at the same time we are conscious that any development should be within the parameters of environmental and ecological concerns and satisfying the principles of sustainable development and precautionary measures.

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The NGT Bench followed this observation with a clear indictment of the MoEF's lack of due diligence in the grant of EC to Posco. It held: A project of this magnitude particularly in partnership with a foreign country has been dealt with casually, without there being any comprehensive scientific data regarding the possible environmental impacts. No meticulous scientific study was made on each and every aspect of the matter, leaving lingering and threatening environmental and ecological doubts unanswered.

The Bench directed the MoEF to define timelines for compliance of the conditions in the ECs and, considering the nature and extent of the project, establish a special committee to monitor progress and compliance on a regular basis.

The Bench's other directions are equally significant. It asked the MoEF to consider the feasibility of insisting on every major industry that requires a large quantity of water creating its own water resource facility rather than using/diverting the water that is meant for drinking/irrigation purposes.

It also wished that the MoEF should establish clear guidelines for project developers to apply for a single EC if it involves components that are essential parts of the main industry. In Posco's case, the main industry is the steel plant, but it involves other major components such as port, captive power plant, residential complex and water supply. The Bench apprehended that separation of the processes of granting ECs for different components would result in uncertainty and waste of resources.

Again, the Bench opined that in large projects such as Posco, where MoUs are signed for large capacities and upscaling is planned within a few years, the environmental impact assessment (EIA) should take into account the project's full capacity, and EC should be granted on that basis.

In the case of Posco, the MoU between the Odisha government and Posco stated that the project was for the production of 12 MTPA, but the EIA report had been prepared only for 4 MTPA in the first phase. This MoU, which was signed in June 2005, was valid only for five years, and it expired in June 2010. The State government and Posco negotiated its renewal with some changes in the original terms and conditions. Some observers, citing the State Law Department's opinion, have suggested that the extension of the MoU should have been achieved before its expiry.

Meanwhile, the Comptroller and Auditor General of India (CAG), in its report (civil) for the year ended March 31, 2011, has indicted the State government, exposing serious irregularities in the entire land acquisition process, including the misuse of the emergency provision of Section 17(4) of the Land Acquisition Act for the purpose. The CAG report has revealed that 4,967 acres (one acre is 0.4 ha) of land valued at Rs.165 crore had been acquired by six corporate houses between July 2002 and 2011 in the State much below the prevailing market rate. Posco India Limited (Jagatsinghpur) is one of these corporate houses. The use of the emergency clause in the Land Acquisition Act deprives the landowners of the opportunity to contest the acquisition and to be heard.

The CAG has also revealed that the land acquired was not put to use for a period ranging from 15 months to six years and three months. The stipulated period within which the acquired land must be put to use is six months from the date of notification of acquisition. The Posco Pratirodh Sangram Samiti has demanded the scrapping or relocation of the project as it would destroy the livelihoods of thousands of farmers. In response to the NGT's verdict, Posco has declared its willingness to comply with it. It perhaps has no choice but to adhere to the fresh conditions imposed, as it has huge stakes in the deal.

After granting the final EC, Jairam Ramesh had gone ahead and accorded the final approval to the State government on May 2 last year for the diversion of 1,253 hectares of forest land in favour of Posco. This decision was equally mired in a controversy as it came after the MoU had expired. Activists had then questioned the urgency with which he had taken the decision in the absence of sufficient legal support. This Forest Clearance was challenged before the Orissa High Court, and the case is pending.

Jairam Ramesh had then claimed that the 60 conditions he had imposed as part of the final EC granted to Posco on January 31, 2011, would ensure that the project would not harm the ecology or local livelihoods. The NGT's verdict shows that his optimism was hollow.

Primer to civil rights

The book brings to the public domain unnoticed aspects of civil rights protection in India.

WE would feel somewhat relieved if we are told by the champions of civil liberties that there are only nine challenges to civil rights guarantees in India and that they are not as insurmountable as they appear to be. A reader of the book under review, Challenges to Civil Rights Guarantees in India, would expect such relief, going by the structure of the book, which is divided into nine distinct chapters, each devoted to the discussion of a single challenge and the possible remedies for it.

However, neither of the expectations is true. The authors have structured the book so only for the sake of convenience. There are indeed far more challenges to civil rights guarantees than the nine identified in the book, and the challenges are so complex that they require eternal vigilance to stop them from overwhelming us.

Nevertheless, the division of the book into nine chapters is an excellent idea to focus our energies on what appear to be clear and present dangers to civil rights in India. The authors, A.G. Noorani and South Asia Human Rights Documentation Centre (SAHRDC), are eminently qualified to help readers pursue such an ambition.

At the outset, the subtle distinction between human rights and civil rights needs to be understood clearly and spelt out if only to avoid epistemological problems that may arise as a result of reading this narrowly focussed but easily readable book.

Human rights comprise economic, social or cultural rights, claims an individual has a right to. They impose on the state a positive obligation to provide the necessary resources so that individuals can enjoy such rights. These rights arise from natural law and are deemed as fundamental to living and survival, and, therefore, deserve protection irrespective of whether the law expressly recognises them or not. Some examples are the right to life, the right to freedom from torture and the right to free movement. Civil liberties, on the other hand, imply a claim to freedom from interference with that claim. They impose a negative duty on the state not to violate that claim. They represent the residual liberty to do anything that one wants unless the law provides otherwise. Civil liberties stem from positive law and include both political and civil rights. These are state-enforced rights. Examples include the right to free elections, the right to vote, the right to fair hearing and the right of the accused to silence.

The distinction between a human right and a civil liberty is not watertight; most civil liberties are also human rights though the reverse is not true. Put in this context, this book deals with that facet of civil liberties, in whose protection rights awareness and rights education play a pivotal role. Protection of political rights, compared with those of civil rights, is easy because violation of political rights by the state is always blatant and invites prompt response in the form of vociferous protests from the affected groups and individuals. The right to vote, the right to form political parties and run for political offices and the right to express dissent in a democracy are all political rights that are jealously guarded by all concerned.

Protection of civil rights, on the contrary, requires eternal vigilance on the part of opinion-makers and people at large because their violation is always subtle and very often happens unnoticed and unopposed. That is why books such as this serve a useful purpose by bringing to the public domain unnoticed aspects of civil rights protection in India. According to Ravi Nair of the SAHRDC, the book is the result of collaborative discussions with Noorani. The impetus for writing the book and the inspiration for its content stemmed from Noorani's articles on a range of civil rights topics that appeared in issues of Economic & Political Weekly and Sunday magazine in the 1980s. Ravi Nair and his team of interns at the SAHRDC provided flesh and blood to the articles (which Noorani describes as a mere skeleton), bringing them up to date so that they qualify as, what Noorani calls, essentially a primer to civil liberties.

It is natural to ask what made the authors identify these nine challenges to the protection of civil rights rather than others for the purpose of the book. What made them choose nine and not eight or seven? A reader can easily infer that the authors feel more strongly about these challenges, perhaps in the order in which they appear in the book.

The first chapter, on preventive detention, shows that right from the time of the constitution of the Constituent Assembly up to the present preventive detention laws in India have rested on a diversity of narratives used to justify perceptions of threat to the Indian nation and its democratic character. The necessary evil justification, first espoused by the framers of the Constitution with respect to the political and social turmoil of Independence and Partition, continues to be relied upon by the executive and Parliament. The only difference is that the contexts of Independence and Partition have been replaced by alleged threats from home and abroad, such as war, foreign relations, internal emergencies, public order, smuggling and terrorism.

The authors, therefore, suggest a number of reforms to preventive detention laws and provisions under the Constitution. These include added protection for detainees against torture and other forms of abuse committed during the course of preventive detention; replacement of the standard of subjective satisfaction with specific reviewable criteria, as currently the law allows the courts to review only whether the detaining authorities took into account all the relevant factors; limitations on the time frame within which judicial review of a detention order must take place, most preferably by requiring that all detainees must be brought before a magistrate within 24 hours of arrest as with ordinary detention; and repeal of Article 22(3)(b) of the Constitution, which denies a detainee under a preventive detention law this right and the right to be informed of the grounds of arrest and the right to consult and be defended by a legal practitioner of his choice.

The authors explain why the reform of preventive detention laws has received scant attention from our law-makers or the civil society, by citing former Chief Justice of India P.B. Gajendragadkar's warning in 1967: The tendency to treat (matters of preventive detention powers) in a somewhat casual and cavalier manner which may conceivably result from the continuous use of such unfettered powers, may ultimately pose a serious threat to the basic values on which the democratic way of life in this country is founded.

The second chapter, which is on extrajudicial killings, deplores the fact that the judiciary has yet to take effective action against the prevalence of encounter killings. Recently, the Andhra Pradesh High Court attempted to respond to the dangerous nature of extrajudicial killings, but the book says that its decision has been undermined by the Supreme Court.

The High Court established three key elements of procedure that must be followed in the wake of an encounter death: If a complaint is filed against a police officer, police personnel are obligated to register a first information report (FIR). The names of the officers allegedly involved in the encounter need not be divulged in the report. Secondly, after an FIR is filed, an investigation must be initiated. The investigation should yield one of the three conclusions: that no killing took place; that the offending officer was justifiably exercising his right of self-defence; or that the killing was inexcusable and illegal. Thirdly, if unconvinced by the investigative report specifically that the offending officer was legitimately exercising his right of self-defence the judicial magistrate is empowered to take cognisance of the case.

The book regrets that the Supreme Court's decision to impose a stay on the High Court's ruling demonstrates its pronounced interest in the idea of preserving police morale. The authors say that the court's track record regarding deference to the police in other cases provides little confidence that the Supreme Court will uphold the High Court's decision or otherwise provide effective safeguards against encounter killings.

In the third chapter, titled Counter-terrorism and Human Rights, the authors observe that the implementation of counterterrorism laws such as the Armed Forces Special Powers Act (AFSPA), the Terrorist and Disruptive Activities (Prevention) Act (TADA), the Prevention of Terrorism Act (POTA) and the amended Unlawful Activities Prevention Act (UAPA) has severely restricted various civil rights and has had an unduly harsh effect on the minority communities. At the same time, terrorist attacks have continued to occur.

The authors quote from relevant Supreme Court judgments to argue that increasing the state's arsenal of powers has not been and will not be effective in preventing terrorism. Such measures only add to the plethora of social grievances that often give impetus to violent struggles against the state, they say. The authors recommend the strengthening of the ordinary criminal justice system to better address the ongoing terrorist activities. Pointing out that conviction rates have dropped from 65 per cent in 1961 to 43 per cent in 2004, they attribute this to police corruption, political influence on the police and prosecution, and the immense backlog of cases before the courts caused by a lack of resources.

In the fourth chapter, on the death penalty, the authors observe that despite the surface-level semblance of a test to determine consistently whether the death penalty should be imposed on a case-by-case basis through a proper weighing of all relevant factors, in practice the broad discretion afforded by the rarest of rare doctrine (laid down in a 1980 case by the Supreme Court) simply allows the courts to impose the death penalty arbitrarily as they see fit.

The rarest of rare doctrine placed an extraordinary burden on the court to carry out an objective assessment of facts to justify the use of capital punishment in a given case, to consider aggravating and mitigating circumstances equally before arriving at a decision, and to provide evidence whether life imprisonment would be futile and whether the convict could not be rehabilitated.

The book refers to Santosh Bariyar vs State of Maharashtra (2009), the case wherein the Supreme Court attempted to interpret the rarest of rare doctrine more stringently and avoided imposition of the death penalty. Unfortunately, the book does not examine the cases decided by the Supreme Court after the Bariyar case. Had the authors considered those cases, they would have concluded that the Bariyar case influenced only some judges and that most others continued to confirm the death penalty as if Bariyar's strict standards did not apply to them.

The authors make out a persuasive case for the executive to declare a moratorium on the death penalty and allow an opportunity for serious debate, reflection and investigation about the efficacy of deterrence/retribution/protection from repetition arguments in favour of the death penalty.

In the fifth chapter, on narcoanalysis, the authors praise the Supreme Court's judgment in Smt. Selvi & Ors vs State of Karnataka (2010), wherein the court banned all involuntary administration of narcoanalysis, which involves injecting an individual with barbiturate drugs in order to induce a state of hypnosis and enable the release of repressed feelings, thoughts and memories. The police had been using this test in many cases to gather evidence, even though it raised serious human rights issues. The court held that narcoanalysis violated the rights against self-incrimination, unlawfully invaded individuals' privacy, and amounted to cruel, inhuman and degrading treatment.

However, the book regrets that the court left a loophole by providing a narrow exception. The court had held in the Smt. Selvi judgment that the evidence gathered as a result of information garnered indirectly from a voluntarily administered test could be admitted into evidence. The authors say that this exception is illogical because the court had clearly stated that information obtained even during a voluntarily administered test was not given voluntarily. They fear that this loophole can perpetuate the use of narcoanalysis, brain mapping or polygraph tests rather than reduce or eliminate them.

In the sixth chapter, the authors acknowledge that videoconferencing offers some potential assistance in handling the cases of a large number of undertrials in Indian prisons but warn that it can infringe on the legal and constitutional right of an accused to a fair trial, due process and adequate representation. Therefore, the book appeals to the government to implement the bail provisions that allow for the release of long-term and indigent undertrials.

In the seventh chapter, the authors review the anti-conversion laws in place in several States. They argue that these laws evince a clear pro-Hindu bias and that they have been framed imprecisely to be applied in an arbitrary and discriminatory manner.

In the eighth chapter, the authors lament that the current state of the law in India continues to allow impunity for even the most serious human rights violations. According to the book, this system allows police officers, armed forces and other security personnel, and other government officials to commit such abuses as torture, extra-judicial killing, and illegal arrest and detention without fear of sanction, and leaves the victims and their families without adequate redress. The authors, therefore, strongly recommend that India must amend or repeal such laws so that government sanction is never required for prosecution and individuals can sue the perpetrators of the abuse or otherwise receive adequate compensation for constitutional rights violation.

In the last chapter, the book reproduces Noorani's article published in Economic & Political Weekly in 2009, making out a strong case for an immediate review of the AFSPA. Noorani is convinced that Section 4 of the AFSPA is manifestly and demonstratively violative of Article 21 of the Constitution, which guarantees the right to life and liberty. Section 4 enables the police officer in a disturbed area to open fire on or use force, even to cause death, against any person who is acting in contravention of any law or order. Noorani calls this a carte blanche unheard of in any other statute in any other democracy. He suggests the setting up of an independent appellate body under the Act to entertain complaints against the armed forces or the police when they operate under the Act.

To sum up, the nine challenges to civil rights guarantees in India, as explained in the book in great detail, are indeed formidable. One cannot be under the illusion that the authorities will readily accept the remedies suggested by the authors to meet these challenges, unless there is strong public opinion in their favour. The book would have achieved its purpose if it succeeds in mobilising such opinion.

Systemic ills

A scholarly work on public health with immense value for pedagogical purposes.

ANY contemporary text on public health presupposes an approach that views diseases and disease control through the curative prism rather than the preventive one. Texts critiquing dominant health ideologies and health systems that have led to unspeakable inequities among populations are rare. The inequities, surprisingly, are today a characteristic not only of developing countries but also of developed ones. Public Health in India, a series of papers written by Imrana Qadeer, seeks to analyse all that went wrong with India's approach to health over the years. Imrana Qadeer is a qualified doctor with a passionate commitment to the rights of the poor, and her writings reflect all that and much more.

In the introductory note by the series editors, the author is described as the epitome of an interdisciplinary vision based on linkages between biomedical and social science orientations. Imrana Qadeer, who retired as a professor from the Centre of Social Medicine and Community Health at Jawaharlal Nehru University, New Delhi, has not only trained many students to think critically and laterally on public health but actively advocated the cause of universal public health, an entitlement that is under serious threat. She has always been very precise in her observations, as is reflected in her view that policy decisions on almost anything, including health, reflect a certain kind of politics eventually. The papers are also about her own reflections in the course of the myriad discussions she has had with people over the years.

Her writings are broadly divided into four categories, which raise pedagogical concerns, policy issues and ideological approaches to health. The four sections discussed in the 17 papers in the book are Knowledge and pedagogy in critical public health, The health status of Indian people: Critical reflections, Policies and planning for health in India and Health and ill-health in a neo-liberal world.

The papers in this first series were written by Imrana Qadeer at various points of her career. They have been compiled in the form of a book that will be hugely valuable for pedagogical purposes and also as a scholarly work on public health.

Trajectory of HSR

Political economy of knowledge: A case of systems research in primary health care in India, the first paper in Part I of the book, sets the pace for the rest of the volume. In it she explains, by tracing them historically, the distortions that crept into health systems research (HSR), which was once a very fashionable tool developed by the World Health Organisation (WHO) to respond to the health management needs of developing countries and link health planning to socio-economic development.

HSR itself develops from systems research, a concept that was applied to technical production systems and later to health and other social sectors. The idea was that all these problems could be solved by good management techniques. On the face of it, it did not appear superficial, but by ignoring the larger determinants of health it got reduced to a concept that could be manipulated by all and sundry using all kinds of jargon.

The application of the HSR model to the primary health care (PHC) system would not have been entirely out of place had it not been for the fact that it ignored quality of life problems in the existing levels of poverty. In time, the definition of HSR was reduced and the linkages were diluted, and by the 1990s, HSR in Indian planning had undergone a transformation; the introduction of reforms in the health sector also happened then. The HSR of the 1990s in PHC reflects little of the debates of the 1970s and the 80s and inevitably, population number and not the problems of population, monetary costs for the state and not the social costs for the poor, and hi-tech instead of a mix of socially sensitive technological strategies became the central focus of the systemic view of donor-promoted HSR, writes Imrana Qadeer.

The second paper in the same section, Beyond Medicine: An analysis of the health status of the Indian people, looks at several dominant perceptions, with a dash of humour. Imrana Qadeer notes that the talk of community health and appropriate technology has become the in thing'. She observes that slogans such as Health for All by A.D. 2000 were just steps for promotion and achievement.

Even though the number of representatives in the area of health has increased, with each claiming to be a spokesperson of public health, there is eventually very little either of the public or of health in their overall activities and understanding. She says that not many have tried to understand the health status of the masses. This chapter looks at the major health problems in the country, using government data to show that the so-called preventable diseases are the major causes of death and disease and that they have persisted in spite of the expansion in the health services structure.

Socio-economic processes play a large role in determining the health of the people, she argues correctly, going on to suggest that in India, very little attention is paid to class analysis of mortality and morbidity rates and patterns. There is no doubt that certain sections of the population have higher mortality and morbidity rates owing to their poor socio-economic status.

Neither the Census nor the Sample Registration System, she writes, provides information on the economic backgrounds, and this makes an economic class analysis of mortality and morbidity difficult. The low investment in health and the disproportionate growth in the expenditure in family planning services also merit a study, she says.

The choice of a perspective, she says in the third paper Critique of Methods and Science , is critical to the effective inclusion of macro-analysis in the theoretical frame of epidemiology. While classical epidemiology looks at populations as an organic whole with its own classes, social groups and their economic and political relationships, and studies the impact of its dynamics on disease phenomena, modern epidemiology, with its high-risk approach, focusses on individuals.

The fourth paper, Health Services System in India: An expression of socio-economic inequalities, is unforgiving about the state of public health in the country. It argues that the health system in any country mirrors the inequalities in the larger social system.

Tackling epidemics

Part II looks keenly at specific areas such as the resurgence of epidemics in the 1980s. The paper Contextualising Plague: A reconstruction and an analysis notes how the government seems more preoccupied with India's image abroad and has failed to use the principles of epidemiology to assess, control and alleviate human suffering. The paper highlights the flaws in the classical sanitarian approach which reduces epidemics to endemic status.

The author underscores the need for a multi-pronged strategy firmly entrenched in the socio-economic context, an idea that gets a fillip in the very next paper, Paralytic Poliomyelitis in a rural area of North India. Effective immunisation is the need of the hour, she says. She notes that some children in the villages of Sonepat (Haryana), the area under study, received immunisation and yet contracted paralytic poliomyelitis. In a large number of cases, the children became paralysed soon after they received the doses.

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Imrana Qadeer argues that merely providing for services is not enough; quality and rehabilitation, where required, should be part of the overall approach. A review of policies restricting budgetary outlays to all such related aspects was equally necessary, she says.

The paper on Reproductive Health: A public health perspective takes the argument for an integrated approach even further. Reproductive health, she writes, cannot be handled in isolation. The paper looks at the concept of reproductive health from the 1980s onwards and its consequences for health research and family planning policies (FPP) in India, including the virulent advocacy of FPP in the developing world and the reasons for it. It points out how reproductive health and population growth are viewed by the women's movement, the government, and international agencies. Each is at variance with the other, and for good reason.

Health planning

The third part of the book argues that despite the tomes of information and experience, health planning in India is in a state of disarray. The first 30 years of health planning, argues the author, involved identifying linkages with developmental processes and self-evaluation. Non-performance was at least acknowledged. The section highlights the gradual shift in approach to health planning. Perhaps this was a natural outcome of the overall shift in the planning process itself.

The overall goals of the various plans beginning with that conceived by the National Planning Committee set up in 1938 under Jawaharlal Nehru and the subsequent ones such as the People's Plan, which was a brainchild of the post-War reconstruction committee of the Indian Federation of Labour, and the Gandhian Plan were to improve the standards of living, reduce inequality and provide public utilities. The constraints, if any, were perceived to be in the areas of manpower, technology and institutional facilities. The vision was near-perfect.

The main effort, Imrana Qadeer says, was to improve nutrition, investment in the health sector, water supply and sanitation. The pressure of the national processes that were created through these multifarious plans, including the Bombay Plan which focussed on industrial growth, resulted in the government setting up the Bhore Committee under Sir Joseph Bhore, a civil servant. Health, unfortunately, continued to be kept independent of overall planning in the assumption that inequality would be tackled, the author says.

Drowning reality

The present trend in planning is not one of analysing evidence, she says, but of drowning reality by presenting large quantities of descriptive statistics without disaggregation or analysis. It is not surprising that the health chapters of the Five-Year Plans become bulkier over time but without any substance, Imrana Qadeer writes. Clearly, there is enough and more evidence through government surveys to show that the state of India's health is far from satisfactory. The withdrawal of welfare and the emergent neoliberal agenda with its thrust on monetarism, markets and centralised control over the global economy have impacted health-sector planning, she says.

The emergence of the middle class, which demands better health facilities and advanced medical services, helped the state in its neoliberal policy shifts. Imrana Qadeer quotes Nehru, who envisioned the use of science and technology to bring freedom and opportunity to the common man, to the peasants and workers of India, to fight poverty, ignorance and disease, and to build a prosperous progressive and democratic nation which will ensure justice and fullness of life to every man and woman. A lot of developments have happened since Nehru's days in health-sector planning, not all of which can be said to be in line with his vision.

Two chapters in Part III devote themselves to a critique of the National Population Policy and the aggressive push for public-private partnerships in health care. A sharp and precise critique of both the draft National Strategy for Social Marketing (NSSM) and the National Health Policy is included in these chapters. The NSSM pushes policy in a direction that changes priorities, making need-based, comprehensive health planning peripheral while legitimising the interests of the private sector.

The volume is well edited and assumes relevance in the context of renewed discussions on universal health care by the government today. It is not that all that is being said is new; it has been there for quite a long time but was deliberately neglected.

The shift from universal health care to targeted interventions and the focus on short-term goals such as the Millennium Development Goals have done colossal damage to the state of India's health. Notwithstanding the outcry against successive governments' approach of viewing health as an isolated part of the planning process, policymaking has shied away from mentioning the word universal for the social sector for more than two decades now.

If universal health care is back on the agenda as a concept, it is a welcome shift. But it needs to be backed by financial commitment by none other than the state.

Romance of Delhi

The book is a work of straight history with an emphasis on highlighting the lesser-known monuments of the city.

RAKHSHANDA JALIL, a prolific writer on literature, culture and heritage, departs courageously from the beaten track on which some pretentious works on Delhi travelled recently. Her aim in this superbly illustrated work is to lift the cloak of invisibility that shrouds Delhi. It is a city that drips with history. Only painstaking and earnest explorers can unravel its mysteries.

She writes: The other Delhi, which I have called Invisible Delhi, waits to be discovered. It holds an embarrassment of riches in the form of countless little-known, seldom-visited, largely unheard-of tombs, nameless pavilions, mosques, madrasas, pleasure gardens, baolis, cemeteries, and much else.

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We have tried to make this a more user-friendly book than the previous editions. We have provided a better map and replaced the illustrations with photographs. The latter has been done upon feedback from booksellers, distributors and readers. We hope that the photographs will make these lesser-known monuments easier to identify and therefore better accessible. Thanks to the collaboration with Prabhas Roy, a photographer of high talent, the aim is amply fulfilled.

The book is divided period-wise pre-Sultanate, Sultanate, Tughlak, Saiyid, Mughal (which demands the largest coverage) and the post-Mughal. A chronology and a bibliography assist the student as does an excellent, easy to follow, Map for Hidden Monuments of Delhi. Prabhas Roy's stunning photographs do the rest.

This is a work of straight history with an emphasis on highlighting the beautiful monuments which have received less attention than is their due. Lovers of Delhi, like this writer, will find it a work that will chart the routes which they can follow to discover a Delhi about which they know far less than they think they do.

Rakhshanda Jalil and Bikash Niyogi might well consider a work of similar quality on the dargahs of South Asia.

Terrorism has no place in Islam'

Interview with Muhammad Tahir-ul-Qadri, scholar of Islamic theology and jurisprudence, on his new book.

DR MUHAMMAD TAHIR-UL-QADRI, more popular as Shaykh-ul-Islam, is one of the most renowned scholars of Islamic theology and jurisprudence from Pakistan. Formerly a Professor of Constitutional Law in the University of the Punjab, Lahore, Pakistan, he founded Minhaj-ul-Quran International, an organisation that teaches non-extremist Islam and is present in at least 55 countries. He was in New Delhi recently to launch his book, Fatwa on Terrorism and Suicide Bombings. He has a huge following in the Islamic world and many have declared him the true leader of Islam. While talking to Frontline, he tried to explain the meanings of Islamic theology and how it is being misinterpreted across the world for political reasons. Belonging to the Barelvi sect, historically seen as opposed to the Deobandi and Wahabi schools, he says differences of opinion always existed in Islam but none of the schools ever taught the killing of non-combatants.

Congratulations on your new book. In recent times, many Muslim scholars have tried to interpret the meaning of jehad politically, but you have tried to rationalise its meaning religiously to suggest that there is no place for terrorism and suicide bombings in Islamic philosophy.

I find some people within the religious circles justifying terror activities to achieve their ulterior aims. So, I thought it was necessary to explain that terrorism has nothing to do with Islam, with the Quran, and with the Sunnah [habits, practices and teachings of the Prophet]. In order to establish that, it was necessary to look into the Hadith [Islamic law], Quranic commentaries and works of Islamic jurists followed by the Islamic Ummah [community]. Extremist interpretations are deviations from true Islamic teachings, which only emphasise peace and calmness.

For example, the words jehad and Shahadat [martyrdom] or the concept of fighting were never used in any of the Islamic literature as killing of non-combatant non-Muslims. None of these terms means killing women and children or old people, priests or sick people. You are not allowed to do these. You are not allowed to demolish temples or churches or synagogues and other places of worships. These words are used only in the context of a just war or a war where you are only defending yourself. These words are valid only if there are two armies fighting each other in a battlefield, as is mentioned in various religious sources.

A separate group cannot declare jehad, as is being seen now. This is not their prerogative, not their right. And even when there is a war between two armies or countries, Islamic teachings have put lots of restrictions. You are not allowed to kill women, children and other such groups as I have mentioned. You are not even allowed to kill non-Muslim traders and farmers as they sustain our economy. You are not even allowed to cut trees unnecessarily. These are prohibitions, which the Muslim Ummah knows. But a few terrorist organisations have led the world to believe that Islam is a violent religion, and I, through my book, wanted to clarify all these doubts by examining the religious texts and other sources. These organisations have misinterpreted the Quran by propagating that the killing of a Muslim is equivalent to the killing of the whole of mankind. Instead, the Quran has specifically said that the killing of a human being, not just a Muslim, is equivalent to the killing of the whole of mankind. The word Nafsan, meaning human being, is used throughout in the Quran.

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Most of the extremist organisations owe their allegiance to the Deobandi or the Wahabi theological schools. How does your book interpret their teachings?

I have interpreted the writings of all the great jurists belonging to all the Islamic schools of law in the world. If you talk of Deoband, I have devoted many pages in my book to talk about the Ulema [scholars] of the Deoband school. I have quoted scholars of the Wahabi, Salafi, Hanafi, Shiites, and all the other prominent schools. And none of them has disagreed with my point of view. I have not neglected a single school of law which is of academic concern in Islamic history.

Are you saying that it is the political agenda of organisations that has led to such construed understanding of Islamic law?

Not only political agenda or international agenda. There can be social and economic factors, local ideologies of governments, which may be responsible. Such violence, with its ideological understanding steeped in Islam, can also be an articulation of social and political frustration of people across the Muslim world. However, these political issues and religious understandings should not be intermingled. There can be democratic and peaceful ways to solve political problems. But it should be made amply clear that Islam and Islamic teachings do not allow killing of non-Muslims and even Muslims who are non-combatant. This is a prevailing phenomenon, which should not only be condemned but should be explained in the light of Quranic teachings.

You have argued in your book that terrorists are like the Kharijites, who appeared during the time of the messenger and formed a rebellious sect to fight against Muslims during the reign of Ali. You also say that Islamic scholars considered it a religious duty to fight and kill the Kharijites if they refused to renounce the violent doctrine. Could you elaborate on this aspect of Islamic history?

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The theological school at Damascus had a political dispute with the fourth Khalifa, Ali. There was a battle. Ali had advocated arbitration between the two sides. It was then, when a few sentimental young people saw that the battle could be settled peacefully, they defected and raised the slogan of violence and took up arms. They formed a new group called the Kharijites, who believed in settling the issue through force. The Holy Prophet declared them as outside the ambit of Islam. I have tried to explain that violent means were not the ideas of our caliphs and our scholars but were, in fact, a deviation from Islamic principles. Violence has always been a Kharijite philosophy and of those who have political agendas. They believed that those who disagreed with them should be killed. Even in the present times, there are groups like these, though under different names.

In the present times, there is a positioning of modernism and its principles as a phenomenon that is against pre-modern religiosity. In this context, what do you have to say about theological states that believe in brutal punishments?

I would not like to comment on theological states and their functioning, but for me, there is no contest or contradiction between modern principles and Islamic theology. It depends on how you look at it. Islam is about restoring social order and dynamics. As I said, such brutalities are outcomes of only some people who misinterpret Islamic texts and have no knowledge of modern scientific principles.

Political interests have guided states, and the name of Islam is wrongly given to misguided decisions. In this context, dictatorships and monarchical rules have been there and improper decisions in the name of Islam are perpetuated to prolong those dictatorships and rules. Monarchical rules are not patronised by Islamic teachings. Democratic decisions are the basic tenets of Islamic teachings. Therefore, the basic principles of Islam and modern requirements of society have no contradiction, in my opinion. The Quran and the Sunnah are wrongly used for political reasons.

The book talks about liberal principles in Islam. Can you also, then, talk about the space for dissent in Islamic history and how it was justified theologically?

The differences of opinion are accommodated right from the 14th century. The Quran says La-Iqra-Ai-Deen. There is no compulsion on anybody to embrace Islam. And at the same time, there is no compulsion within the deen of Islam. That is why you find differences of opinions in many schools of jurisprudence in Islam. We have, in those schools, different verdicts for the same incidents in Islamic history which have been made because of different reasoning and different traditions. There is a universal framework, but within that there are different opinions. That is why different schools of jurisprudence were established. None of them, including the Shiite philosophy, has declared that kafirs [non-believers] are outside the ambit of Islam. They are also allowed to go for the Haj. The philosophy of Hadith-Ikhteda-Ummati-Rahmatul is stressed all the time. It means that the differences of opinion in good faith is mercy in the Ummah. It gives you alternatives, substitutes. In the last two years, young people have received this kind of understanding with great ease.

Finally, what is the history of fatwas?

The word fatwa originated in the Quran and the Sunnah. This word was commonly used during the days of the Holy Prophet and his companions as a governance tool. The problem with the word arose when some clerics, especially in South Asian countries, misused this word because of their personal prejudices. These clerics are to Islamic philosophy as quacks are to medicinal studies. Fatwa is a highly qualified juristic term. Qadis [judges] and muftis [lawyers] have used it constantly. Fatwa and Ifta are similar terms, which are used only in crucial judgments.

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