The Novartis vs Union of India case challenging the interpretation of Section 3(d) of India’s patent law came to an end on december 4, after 12 weeks of hearings in India’s Supreme Court, according to an update from Médecins Sans Frontières (MSF).
Section 3(d) led to Novartis being denied a patent for imatinib mesylate (marketed by Novartis as Glivec). Novartis is contesting the Indian patent office’s and appellate body’s decisions to reject the company’s application for a patent on the salt form of imatinib.
Final arguments commenced on September 11, starting with the two judges presiding over the case heard arguments from Novartis as to why they deserved a patent on the mesylate salt of the blood and intestinal cancer drug imatinib.
This was followed by arguments from the counsel for the Indian government, and then representatives for the Cancer Patient Aid Association defending India’s stricter patentability criteria that discourages patenting of new forms of known medicines.
This case has garnered a lot of global attention as it is a “precedent-setting case”, as Leena Menghaney, Access Campaign Manager India, MSF puts it. As the case nears it end, NGOs and patient activist groups have made their stance very clear. Meghaney hopes that “the integrity and intention of India’s patent law, and Section 3(d) in particular, is upheld. India’s ability to continue production of affordable medicines for the developing world depends a great deal on the country’s patentability standards and how they are interpreted by the courts in India.”
MSF believes that a win for Novartis would set a dangerous precedent, severely weakening India’s legal norms against ‘evergreening’, a common practice in the pharmaceutical industry. In this case Novartis is pushing for an interpretation of patentability standards that would inevitably lead to patents being granted far more widely in the country, blocking the competition among multiple producers which drives down prices, and restricting access to affordable medicines for millions in India and across the developing world.
The other end of the spectrum is represented by a recent blogpost on a personal blog PILMAN of Tapan Ray, Director General, Organisation of Pharma ceutical Producers of India, (OPPI), which represents MNC pharma companies like Novartis in India. Ray lists fostering innovation and intellectual property rights (IPR) as one of the ‘Nine Major Challenges Constraining Indian Pharmaceutical Industry From Taking a Quantum Leap’. Provisions in the Indian Patents Act like Section 3d ‘throw a major challenge to the global innovator companies spreading across the continents to get many of their new molecules patented in India and subsequently launch in the country.’ While the judges have now retired to consider their verdict, there is no indication at this stage to suggest when the judges may hand down their findings.
EP News Bureau – Mumbai