Big Pharma is keenly waiting for the last word on the legal battle being waged in the Supreme Court over patent protection for Swiss pharma giant Novartis' anti-cancer drug, Glivec. The apex court's decision, due on Monday, assumes significance as it is expected to bring clarity not only for Novartis' drug, but on the overall interpretation of a particular section, 3 (d) in the patent law.
Section 3(d) prevents what the industry calls 'evergreening' - a process of churning out a version of the medicine with only incremental modification and no innovation, simply to prolong a patent's life.
While the Glivec case has triggered a big debate on the degree of innovation required for a patent in India, multinationals and other stakeholders, including generic drug makers and patient groups, are waiting for the apex court's decision, for it can have major implications.
"We would like legal clarity on what kind of medicines would qualify as innovative products in India," says Paul Herrling, head of tropical disease research at Novartis.
The government, which refused patent protection for Glivec in India, argues the drug is simply a retooled avatar of an existing version and, therefore, doesn't deserve one here.
However, Novartis has maintained it cannot be accused of evergreening. According to the company, imatinib mesylate is the salt form of an older medicine, imatinib, and the new version represents a 30 per cent increase in the bio-availability of the medicine.
Multinationals have indicated the government needs to incentivise innovation and research for attracting investments in new drug discovery in the country. Experts say the SC decision is expected to impact the strategy of multinational pharmaceutical companies in the country.
"Big Pharma has had a few setbacks in India recently, most related to patentability. This decision would be significant because it would bring clarity for MNCs on incremental innovation," says a pharma expert. "India has worded and negotiated the law very carefully. While it wants to prevent evergreening of patents, it is also important for India to respect patents. Otherwise, it will upset the innovator companies which spend on research to develop new medicine".
Recent developments in India have also induced a feeling of uncertainty in Novartis, which fears losing the battle on Glivec. "Looking at recent cases, the mood in India makes it more likely that we would have a more negative response," says Herrling.
Last year, India granted compulsory licence to domestic drug maker Natco Pharma, allowing it to sell generic version of Bayer AG's anti-cancer drug Nexavar at a lower price. Besides, India also revoked a few patents recently on grounds of lack of innovation. These included patents granted to Pfizer Inc's anti-cancer drug Sutent, Roche Holding AG's drug Pegasys for treatment of hepatitis C, and Merck & Co.'s asthma treatment aerosol suspension formulation.
"Currently, the climate is not conducive in India for attracting investment in research and development for discovering innovative drugs. Through this case, we are only trying to gain clarity on unique provisions of Indian patent law because ruling by the court would be an important step in determining how India would implement intellectual property laws for addressing unmet medical needs," says Ranjit Shahani, vice chairman and managing director of Novartis India.
However, health activists and patients say that secondary patenting is not only a threat to affordable medicines, but also to innovation of meaningful drugs. "There is no bar on granting patents on new molecules, but by giving patents to 'me-too' versions of older molecules, one can actually abuse the patent system. Why should a company go for new R&D if the threshold for the incentive is so low?" asks Leena Menghaney of Medecins Sans Frontieres, which campaigns for access to essential medicines.
If the court decides in favour of Novartis, then there is also a possibility that various old cases where patents were denied on the basis of Section 3 (d) would be reopened, says another expert.
"A liberal decision in favour of Novartis would result in high prices of medicines, more patents and hence monopoly in the drug market," says K M Gopa Kumar of Third World Network.