Beaten challenge

The Madras High Court rejects pharma major Novartis petition against a provision of the Indian patent law.

FOR the 32 million people in India suffering from diabetes, for the 36 million with coronary heart disease, the 5.2 million living with HIV (human immunodeficiency virus), the 3.3 million with TB (tuberculosis), the 1.2 million with malaria, the 25,000 people diagnosed each year with chronic myeloid leukaemia, and for the government agencies, hospitals, non-governmental organisations (NGOs) and patient groups distributing medicines, the Madras High Courts August 6 rejection of Swiss pharmaceutical giant Novartis challenge to the Indian government is significant.

It means that patients will not have to fork out lakhs of rupees for treatment every month because generic versions of brand-name medicines will continue to be available at low cost. In fact, for the multitudes of the poor or even for the throngs earning the average wage it means the difference between medicine and no medicine at all.

The case brought by Novartis was originally about getting a patent for their blockbuster anti-cancer drug Gleevec (Glivec), the treatment for chronic myeloid leukaemia. Having unsuccessfully opposed objections to the patent by the Cancer Patients Aid Association (CPAA), Mumbai, and domestic pharmaceutical companies Cipla, Hetero, Natco and Ranbaxy before the patent office in 2006, Novartis moved on to the next level.

In the High Court hearing this year, it challenged these organisations, Sun Pharma, the Indian Pharmaceutical Alliance, the patent office and the Union of India over the very law upon which that decision turned.

Reflecting the significance of this challenge, the High Court moved the challenge on the rejection of the patent on Gleevec to the Intellectual Property Appellate Board (IPAB), Chennai, and proceeded to hear the challenge to the law.

The patent for Gleevec was rejected in 2006 because under Indias patent law, which does not recognise patents given to products before India joined the World Trade Organisation (WTO) in 1995, patents will be given only to new innovative drugs, and not to new forms or new uses of known drugs that already have a patent, unless the new form is significantly more effective.

Gleevecs key ingredient (imatinib) had been patented in 1993 and its new form (beta salt crystals) was not found to benefit patients in any significant way over the original.

Novartis case, which was argued by two of Indias best-known lawyers Soli Sorabjee and Shanthi Bushan, had two prongs. First, the company argued that the part of Indian patent law detailing what can be patented Section 3(d) did not comply with WTO intellectual property rules and that India should, as a member of the WTO for more than 10 years, ensure that its domestic law matched its international obligations. Second, it claimed that the section infringed its right to equality under Article 14 of the Constitution. The use of the term efficacy, it argued, was vague, ambiguous and could be interpreted arbitrarily by the patent office.

In response, the Government of India, the CPAA and domestic companies argued that private companies such as Novartis could not challenge a domestic law by comparing it with an international treaty because only states had that right.

Further, they argued that domestic courts could not judge whether a law made in Parliament interpreted correctly international trade obligations because that would be above their remit. On Article 14, they submitted that the concept of efficacy was well known to persons in the pharmaceutical industry and it was impossible to lay down a one-size-fits-all standard.

But Justices Prabha Sridevan and R. Balasubramanian found that when a domestic law is challenged on the grounds of it being in violation of an international treaty, domestic courts have no jurisdiction. They declined to issue the declaration Novartis sought if the court could not strike down Section 3(d) because, they said, it would serve no useful purpose. They noted that the forum to determine whether a national law complied with WTO intellectual property rules was, as stated in the rules themselves, the WTO disputes settlement board. On the question of interpretation of significant efficacy under Article 14, the court found that the concept of enhanced efficacy had clear meaning in the pharmaceutical industry, that the term significant was valid because it had to be applied across a myriad of factual circumstances and that there are in-built materials [in Indian patent law] which would control/guide the discretion to be exercised by the [Patent Controller].

Had the case gone in favour of Novartis, aid organisations and patient groups say, the consequences would have been severe. First, it would have prevented Indian companies from making available generic medicines for leukaemia at roughly one tenth of the Rs.1,25,000 a month that Novartis charges for Gleevec. We fought for patients rights and we are greatly relieved that the court has ruled in our favour and recognised that patients, more than patents, need protecting, said Y.K. Sapru, founder and chairman of the CPAA.

Second, it would have set a precedent for other international companies to prevent Indian-manufactured cheap alternatives to brand-name drugs for a raft of diseases by re-patenting their drugs with minor changes. There are 9,000 patents applications pending before the courts, most of them for these types of changes.

[The judgment] will ensure that frivolous patents will not be granted at the cost of public health, said Chan Park of the Lawyers Collective HIV/AIDS Unit, which argued the case for the CPAA.

Third, it would have cut off the supply of cheap medicines not just in India but in African countries and other parts of the developing world that rely on medicines exported from India.

This is a huge relief for millions of patients and doctors in developing countries who depend on affordable medicines from India, said Dr. Tido von Schoen-Angerer, director of the Medecins Sans Frontieres (MSF) Campaign for Access to Essential Medicines, in a statement from Geneva. Developing-country governments and international agencies such as the United Nations Childrens Fund (UNICEF) rely heavily on importing drugs manufactured in India; Indian companies supply 84 per cent of the antiretrovirals that MSF prescribes worldwide.

However, Novartis says that the judgment will have a negative impact on public health in the country, because recognising incremental innovation was important in the development of new medicines (see box).

Speaking to Frontline over the telephone from Mumbai, Ranjit Shahani vice-chairman and managing director, Novartis India Limited, said: Because India does not have strong intellectual property law, no company will launch thei r latest patent product as a result of this judgment. It is not so far-fetched as it sounds. Abbott recently withdrew seven new products from the Thai market when the Thai government issued its antiretrovirals under an emergency licence.

Further, Shahani said the absence of a strong intellectual property law would discourage investments in research and development in India. Companies, he said, will invest in China instead. He called on groups such as the WTO and the Indo-American Chamber of Commerce to push for stronger intellectual property laws.

For the Indian pharmaceutical industry, D.G. Shah, secretary-general, Indian Pharmaceutical Alliance, said: The courts decision is a sigh of relief from expensive and lengthy litigation in the future, and allows companies to continue to market not only imatinib mesylate [Gleevec] but also other similar molecules for which patents are claimed for trivial changes in India.

Responding to Novartis statement, he asked if the company threatened to deny patients access to their patented medicines to force India to amend its patent law. He also said the judgment demonstrated that the country had an independent judiciary that was competent to handle complex cases relating to intellectual property law.

Dr. Yusuf Hamied, chairman and managing director of Cipla, agreed. If [Section] 3(d) holds it is better for Cipla and the domestic pharma industry. It prevents frivolous patenting and future litigation costs.

Although, he said, the court could have thrown out the case on the grounds of lack of jurisdiction at an early stage, the judgment ruling that the term significant efficacy was valid was an important one.

Over and above this, the case has tested and proven the primacy of the creation and maintenance of law in the country when faced with a challenge from an international company. The amendment has been upheld. Any application for patents will be decided in accordance with Section 3(d), V.T. Gopalan, Additional Solicitor-General of India, told Frontline.

R. Vaigai, counsel for the CPAA, said: The only remedy left is not to challenge the provision of law, but to file an appeal under the Patents Act. It reiterates the peoples authority to decide for themselves what is law. The law is a sovereign instrument.

Making their closing remarks, Justices Prabha Sridevan and R. Balasubramanian said: We have borne in mind the object which the Amending Act wanted to achieve, namely to provide easy access to the citizens of this country to life-saving drugs and to discharge the constitutional obligation of providing good health care to its citizens.