The petition of Novartis AG challenging the refusal of Patent Office to grant patent for its block buster drug Gleevec (Imatinib Mesylate) will be heard by a division bench of the Chennai High Court next month. The single bench decided to refer the case to the division bench as desired by the petitioner. Novartis had questioned the constitutionality of section 3(d) of the Indian Patents Act which was specifically introduced by the Indian parliament to protect against obtaining patents on old medicines i.e. trivial patenting, new use patents etc.

It was in May 2006, Novartis filed two cases in the Chennai High Court challenging the refusal of the application filed by Novartis for a patent on 'Gleevec' and the constitutional validity of 3 (D) of Patent Act. The Novartis appeal came after the Chennai Patent Office rejected the patent application in January 2006 on the ground that the application claimed 'only a new form of an old drug', which does not qualify for patentability.

In 1998, Novartis filed a patent application in India for Gleevec, the drug essential in prolonging the life of patients suffering from Myeloid Leukemia (Blood Cancer). Based on the patent application and a particular provision of the Indian Patents Act, Novartis in 2003 obtained an exclusive marketing right (EMR) for a period of five years. The EMR operated like a patent monopoly preventing Indian pharmaceutical companies from producing affordable generic versions of the drug Imatinib Mesylate (Gleevec). Companies like Hetero, Ranbaxy, Cipla had to withdraw from producing and marketing the drug in India and other developing countries. After the refusal of the patent application, all generic companies are once again in the fray with their versions of Imatinib Mesylate.
Public interest and health NGOs world over are watching the particular Novartis case keenly as the decision on this case could alter their current plans for sourcing affordable medicines. In a press statement, International medical humanitarian organisation Médecins Sans Frontières (MSF) warns that this case may have serious implications for future access to essential drugs worldwide.

"If Novartis' challenge against the Indian patent law is successful, a key safeguard that can protect the production of affordable medicines will be lost," stated Ellen 't Hoen, Policy Director at MSF's Campaign for Access to Essential Medicines. "People the world over who rely on India as a source of their medicines may be affected if Novartis gets its way."

India has been a crucial source of affordable generic medicines for MSF with 84 per cent of the AIDS drugs MSF uses to treat over 60,000 patients in more than 30 countries being generics from India.