New Delhi - A challenge against India's patent law filed by the Swiss pharmaceutical company Novartis will be heard in the Chennai High Court in India tomorrow. International medical humanitarian organisation Médecins Sans Frontières (MSF) warns that this case may have serious implications for future access to essential drugs worldwide.
Novartis is challenging a crucial part of the Indian law that protects patients from the patenting of trivial improvements of known molecules. Novartis is also seeking to have the January 2006 decision to reject its patent application for the cancer drug Gleevec reversed and is seeking review by the Chennai High Court.
"If Novartis' challenge against the Indian patent law is successful, a key safeguard that can protect the production of affordable medicines will be lost," said 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, and 84% of the AIDS drugs MSF uses to treat over 60,000 patients in more than 30 countries are generics from India.
India began reviewing pharmaceutical product patent applications in 2005, when it was required to become fully compliant with World Trade Organization rules on intellectual property. The Indian patent law has strict criteria regarding which inventions qualify for patenting, and allows for any party to oppose a patent before it is granted.
In 2005, cancer groups filed the first ever 'pre-grant opposition', against Novartis' patent application for Gleevec. MSF has supported similar oppositions filed by patient groups in India against patent applications on key AIDS drugs.
"The public health safeguards of the Indian Patent law have given hope to many who depend on generics manufacture. The Novartis litigation is a direct challenge to those safeguards," said Leena Menghaney, MSF Campaigner in India.
Novartis claims that Section 3(d) of the Indian Patents Act is not compliant with the WTO rules outlined in the agreement on Trade-related Aspects of Intellectual Property (TRIPS). Section 3(d) formed a substantial part of the basis on which the Gleevec patent was originally denied.
Many public interest and health groups will be watching the hearing closely, as the Gleevec patent order set an important precedent for the examination of other drug patent applications. A protest by cancer groups in Mumbai will take place at 5:00 p.m. September 12 at Azad Maidan.