Patents and the law

PAUL NORONHA

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.

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.

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?