The gliptin furore: commercial litigation in India

The Supreme Court’s affirmation of the High Court injunction related to the infringement of Merck’s Indian patent for sitagliptin, an oral hyperglycemic drug brings a unique perspective on patent litigation in India, specifically in commercial litigation.

The last two years have seen a sudden spike in patent litigation by innovator companies in relation to so called gliptin molecules. Gliptins are di-peptidyl peptidase IV inhibitors, which is a new class of oral medicines for the treatment of type 2 diabetes. A probable reason for this sudden interest by the domestic pharma industry is the huge market potential gliptins have in India. It is estimated that the market share of gliptins in anti-diabetic therapy in India is Rs.8 billion ($125 million) and is growing at 20% annually.

The first gliptin (DPP-IV inhibitor) that was approved in 2006 was sitagliptin by Merck Sharpe Dohme. In2007, vildagliptin by Novartis was approved. The other approved gliptins in India include axagliptin by Astrazeneca and alogliptin by Takeda. AII these molecules now successful drug products, are protected through patents and have been involved in patent litigation in India.

Authored by Archana Shanker.

This article was published in MIP’s IP Stars Handbook 2015.

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