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Verdict will impact public health

CHENNAI: The verdict of the Madras High Court on Monday against Novartis has far-reaching implications for access to medicines, according to both Novartis and Medecins Sans Frontieres. However, that is where the agreement ended.

“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 MSF Campaign for Access to Essential Medicines, in a statement in Geneva. “The court’s decision now makes Indian patents on the medicines that we desperately need less likely. We call upon multinational drug companies and wealthy countries to leave the Indian Patents Act alone and stop pushing for ever stricter patent regimes in developing countries.”

“It is clear there are inadequacies in Indian patent law that will have negative consequences for patients and public health in India,” said Paul Herrling, Head of Corporate Research at Novartis, in a statement. “Medical progress occurs through incremental innovation. If Indian patent law does not recognise these important advances, patients will be denied new and better medicines.”

Ellen t’Hoen, policy director of MSF Access to Medicines Campaign, however, told The Hindu over the phone from Geneva: “The reality today is that despite the fact that patent protection has increased, innovation has decl ined dramatically in terms of new products. If you assess them form a therapeutic point of view, they are less and less meaningful. You cannot say more patents lead to more therapeutic benefits for patients. If it does lead to more therapeutic benefits, patents lead to a situation where only a minority of the population can benefit because only a few people can afford them — what kind of innovation is that?”

The judgment, she said, may actually stimulate innovation; it awards patents not only for genuine innovation but also on products that have had small changes but significant increases in therapeutic benefits for patients.

Ranjit Shahani, Vice-Chairman and Managing Director of Novartis India Ltd., remained steadfast in his view that this would have a negative impact on public health in the country. “Because India does not have strong IP law no company will launch its latest patent product as a result of this judgment. This will not bring the latest medicines to India.” He also said that it would discourage investments in research and development.

Novartis had challenged Section 3(d) of Indian patent law, which was inserted by the government to protect patients against high prices that would have followed patents for small changes in drugs that did not have a significant increase in efficacy. The company argued that this contravened the international agreements on intellectual property at the WTO.

R. Vaigai, counsel for Cancer Patients Aid Association (CPAA) of India, said: “It’s a very important judgment. If Section 3(d) is valid, the only remedy left is not to challenge the provision of law, but file an appeal under the Indian Patents Act. It reiterates the people’s authority to decide for themselves what is law. The law is a sovereign instrument, TRIPS is merely a contractual agreement of international parties on trade interests. This precedent is the first of its kind. It will have implications the world over for access to medicines.”

Dr. Yusuf Hamied, Chairman and Managing Director of Cipla, told The Hindu over the phone from London that the case should have been thrown out of court in the first instance and that time and money had been wasted in the pursuit of a judgment that could have come much earlier. However, he said, “the decision is pro-India and not pro-Novartis. I am delighted.”

D.G. Shah, Secretary-General of the Indian Pharmaceutical Alliance, said: “For the Indian pharmaceutical industry, it [the judgment] is a sigh of relief from expensive and lengthy litigations, and allows the domestic industry to continue to market not only imatinib mesylate (Gleevec) but also other similar molecules for which patents are claimed for trivial changes in India.”

It is not yet clear whether the Swiss-based Novartis will appeal to the Supreme Court against the verdict, or whether it will appeal to the Swiss government to bring India before the international tribunal in Geneva.

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