India’s Gleevec Ruling Is Bad News For Other Drugmakers, Too
Make a commentBy Ed Silverman // August 7th, 2007 // 5:17 pm
How’s that? Well, most of the 150 patent filings in India made by local units of foreign-owned drugmakers, such as Pfizer, Merck and AstraZeneca, among others, will likely be affected by the Monday court ruling that struck down the challenge by Novartis over a key clause in India’s patent law, according to LiveMint.com. The applications are opposed by local drugmakers and patient groups.
Prominent among these 150 “pre-grant†oppositions are some that involve an AstraZeneca’s lung cancer drug and a cholesterol-lowering med; a Pfizer treatment for fungal infections; Roche’s Tamiflu bird flu med, and Eli Lilly’s erectile dysfunction drug. Pre-grant opposition allows a company or individual to oppose claims in a patent application before its granted.
Lawyers Collective, a group of advocates engaged in public health and drug access issues, is challenging the grant of patents to several HIV drugs such as Merck’s Efavirenz, Gilead Sciences’s Tenofovir and Amprenavir, and also Roche’s hepatitis drug Pegasys, contesting the incremental innovation claimed by the applicants, the site reports. The group has filed 15 pre-grant oppositions against patent applications, says Anand Grover, project director of the HIV/AIDS unit at the lawyers’ group.
The Madras high court on Monday dismissed Novartis’ challenge to Section 3(d), which bars a patent grant for drug derivatives that are not sufficiently innovative. The court said it could not judge if the Indian law was compliant with the Trade Related Aspects of Intellectual Property Rights agreement in this case, and said this should be taken up before dispute settlement body set up for the purpose by the World Trade Organization.
Novartis’ challenge was part of its legal fight in India against a decision by the country’s patent office to disallow a patent for its cancer drug, Glivec (sold as Gleevac in other parts of the world) because this was an incremental innovation.
The ruling has put a lot of applications looking to patent incrementally innovative products on a ’sticky wicket’ and averted the attack on Section 3(d) which, according to public health groups, ensures supplies of cheap non-patented drugs to patients around the world.
Several patent applicants, whose products were facing the same grounds of opposition as Gleevec, were awaiting Monday’s verdict as a way forward for their products, according to patent attorney Hemant Singh. “The fate of those applications has been sealed following the Novartis judgement,†says Singh.
The Indian Pharmaceutical Alliance’s secretary general D.G. Shah estimates that almost 2,000 applications of a total 10,000 could get rejected, following the high court ruling.
Leena Menghaney of Medecins Sans Frontieres forsees governments of developing countries becoming more confident in creating provisions similar to Section 3(d). Developing countries are increasingly turning to makers of generic drugs to reduce public healthcare costs and extend the reach of life-saving medicines to the poor.
Brazil recently broke the patent of the HIV drug Efavirenz - it’s the second country to do so after Thailand - after negotiations with Merck fell through, although they subsequently reached an agreement. Thailand has already revoked patents for two AIDS drugs - Merck’s Stocrin and Abbott’s Kaletra - and heart drug Plavix by Sanofi-Aventis.