Indian Supreme Court To Hear Novartis Challenge To India’s Patent Law

The Indian Supreme Court today is expected to hear Swiss pharmaceutical company Novartis’ case against a provision of Indian patent law aimed at preventing the extension of drug patents for minor changes in existing products, a practice known as evergreening. [Update: according to sources, the case has been temporarily adjourned after concerns raised about industry ties of one of the judges.]

[News background on the temporary adjournment available here (Times of India).]

Non-governmental groups and HIV/AIDS activists are concerned that if the Supreme Court overturns Section 3(d) of the patent law it could undermine India’s generic drug industry, which provides the majority of the developing world’s affordable medicines.

“Novartis is trying to straightjacket Indian patent offices. It wants to stop them from being able to reject patents on new forms of old medicines that show little improved therapeutic efficacy,” said Leena Menghaney, India Manager of the MSF Access Campaign.

India passed its patent law in 2005 in compliance with its World Trade Organization commitments. The legal battle goes back to 2006, when the Indian patent office rejected a patent application for imatinib mesylate (sold as Glivec or Gleevec), a cancer medicine. A legal challenge by Novartis lost in 2007, as did an appeal in 2009 (IPW, Public Health, 2 September 2009).

Novartis is seeking a patent on a new crystalline salt form of the anti-cancer drug, but in 2006, the Indian patent office ruled that the new salt form did not warrant a new patent, since it did not meet the standard of “increased efficacy” required under Sec. 3(d).

“If Novartis succeeds in weakening the interpretation of Section 3(d) for the purpose of obtaining a patent on a specific salt of the anti-cancer drug imatinib, it would force India to grant far more patents than it currently does or is required to under international trade rules,” said Dr Amit Sengupta of People’s Health Movement. “This could lead to generic competition on many essential drugs ending entirely and prices for these in both India and developing countries remaining very high.”

“Decisions made by Indian patent offices and Indian courts are a question of life or death for people living with HIV/AIDS,” said Loon Gangte, of the Delhi Network of Positive People (DNP+). “We rely on the availability of affordable AIDS drugs and other essential medicines made by Indian generic manufacturers to stay alive and healthy.”

A Novartis spokesperson could not be reached for comment at press time. Novartis has argued in the past that the case is not about access to medicines since such a small population uses Glivec, but rather about clarifying intellectual property rights in India (IPW, Developing Country Policy, 15 February 2011).