New Delhi / Mumbai: Most of the 150 patent filings in India made by local units of foreign-owned drug firms such as Pfizer Inc., AstraZeneca Plc., and Merck & Co., among others, will likely be affected by a Monday ruling of the Madras high court that struck down Swiss drug maker Novartis AG’s challenge of a key clause in the Indian patent law.
These applications are being opposed by local pharmaceutical companies and patient groups. Prominent among these 150 “pre-grant” oppositions are those that involve AstraZeneca’s lung cancer drug Gefitinib and cholesterol-lowering medication Rosuvastatin, Pfizer’s Voriconazole that is used to treat fungal infections, Roche’s bird flu medication Oseltamivir and Eli Lilly & Co’s erectile dysfunction drug Tadalafil.
Pre-grant opposition allows any company or individual to oppose claims in a
patent application before its grant.
Bitter pill: The ruling has put a number of applications looking to patent incrementally innovative products on a sticky wicket and averted the attack on Section 3(d).
Lawyers Collective, a group of advocates engaged in public health and drug access issues, is challenging the grant of patents to a bunch of anti-HIV drugs such as Merck’s Efavirenz, Gilead Sciences Inc.’s Tenofovir and Amprenavir, as also Roche’s hepatitis drug Pegasys, contesting the incremental innovation claimed by the applicants. “Lawyers Collective itself has filed 15 pre-grant oppositions against patent applications. All these cases will come under the purview of Section 3d of the Patents Act,” said 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 to 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 Glivec, were awaiting Monday’s verdict on the way forward for their products, according to patent attorney Hemant Singh. “The fate of those applications has been sealed following the Novartis judgement,” said Singh.
Trade lobby 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.
Drug access campaigner 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 is the second country to do so after Thailand—after price negotiations with Merck fell through. Thailand has already revoked patents for two AIDS drugs—Merck’s Stocrin (efavirenz) and Abbott Laboratories Ltd’s Kaletra—and heart drug Plavix by Sanofi-Aventis SA.