In a patent suit that has grabbed eyeballs across national and international media, the Glivec case has become more than just another piece of litigation. While Novartis has come under fire from NGOs in India who accuse it of pursuing a case that will reduce the common man's access to medicines, internationally, pharma majors are closely tracking the case to get a sense of the Indian patent law.

The Glivec case revolves around Novartis's anti-cancer medication, for which Novartis is seeking a patent based on beta crystal salt of the active compound. Novartis has appealed to the Supreme Court of India for the grant of a patent, based on increased safety due to modification of the naked chemical molecule, thus making it safe for use. In an interview with BioSpectrum, Mr Ranjit Shahani, vice chairman and MD, Novartis India, who is also president of Organization of Pharmaceutical Producers of India (OPPI), talks about why Novartis chooses to pursue the case, their access program, compulsory licensing and more.

What are the implications of the verdict in this case for Novartis in India?
We would not like to speculate on the outcome of the case. However, it is important to know that the available generic drugs launched in India before 2005, including HIV/AIDS medicines and generic versions of Glivec, will continue to be available under a grandfather clause in the Indian patent law, regardless of the legal outcome of our case.

Obtaining a patent for Glivec in India is important to Novartis because we want to ensure effective protection for innovation. We are seeking clarity on the application of patent law in India. Knowing that we can rely on patents in India benefits government, industry and patients because research-based organizations will then know if investing in development of better medicines for India is a viable long-term option. The cost of a year of generic treatment is $2,100 or three-to-four times the average annual income.

The current case is challenging the court's view of not recognizing increase in efficacy as an incremental innovation, in line with the 3(d) amendment of the Indian Patents Act. Most critics argue that this is just an example of evergreening. What is yor opinion?
Novartis takes the view that Section 3(d), the Indian legal paragraph intended as a hurdle for "evergreening", is not applicable at all to Glivec.