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India’s patent office at odds with Big Pharma Posted 14/12/2012

India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Somewhat controversially the office has been asked by the Supreme Court, however, to reconsider Pfizer’s patent on Sutent (sunitinib). Meanwhile, it is still to issue a final verdict in Novartis’ legal challenge against India’s patent laws.

India’s Intellectual Property Appellate Board dismissed an appeal filed by AstraZeneca challenging earlier rulings in August 2007 and May 2011 concerning its patent for the company’s kidney and liver cancer drug Iressa (gefitinib). The board, for the third time, said it did not find merit in the appeal, claiming the invention was obvious.

In an unexpected decision based on recent events, India’s Supreme Court has asked the Patent Office to reconsider their rejection of Pfizer’s patent on Sutent (sunitinib). However, the Supreme Court has also lifted an injunction, which was awarded to Pfizer, preventing Indian drugmaker Cipla from launching a generic version of Sutent.

The most high-profile case is Novartis’ legal challenge against India’s patent laws following rejection in 2006 of the company’s patent application for its leukaemia treatment Glivec (imatinib). The challenge specifically relates to Section 3(d), which states that a modification of a known chemical composition is non-patentable – the reason for rejection of Novartis’s patent on Glivec. The case has now concluded after evidence was heard for 12 weeks in India’s Supreme Court. A verdict is expected by the end of the first quarter of 2013.

Earlier in 2012, an Indian ruling granted a compulsory licence, allowing a local India-based generics firm Natco Pharma to produce a cheaper generic version of German pharmaceutical giant Bayer’s patented drug Nexavar for liver and kidney cancer (sorafenib) [1].

These rulings show that India is taking a hard line against foreign pharma companies and will not permit companies to just tweak formulations in order to obtain a patent in the country, despite the same patents being accepted in other parts of the world.

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1.  GaBI Online - Generics and Biosimilars Initiative. Bayer loses Nexavar compulsory licence appeal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Dec 14]. Available from: www.gabionline.net/Generics/News/Bayer-loses-Nexavar-compulsory-licence-appeal

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Source: Reuters, The Times of India

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