Success Story Turns Bleak for Compulsory License

Efforts to protect innovations through India IPR policy have received a leg up, but the rejection of a compulsory licence application proves the real icing on the cake.

The government’s commitment to the global community at large to protect innovations is now visible through India’s national IPR policy, Make in India and the recent success stories in the Merck and Hoffman La Roche patent infringement actions. The icing on the cake was the recent rejection of the compulsory license application of Lee Pharma, a Hyderabad-based generic company, for AstraZeneca’s patent for saxagliptin. Since 2011, three applications have filed under Section 84 of the Indian Patents Act. While the Controller General granted a compulsory license to Natco for Bayer’s patent for Nexavar, BDR Pharmaceuticals’ and Lee Pharmaceuticals’ applications for compulsory license for patent claims on dasatinib (Bristol-Myers Squibb) and saxagliptin (AstraZeneca) were prima facie rejected in 2014 and 2015-2016.

This article walks through the compulsory license proceedings of Lee Pharma for saxagliptin. 

Authored by Pravin Anand and Archana Shanker.

This article was published in Asia IP February 2016.

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