Data exclusivity in India: a new tool for innovators?


Data exclusivity in India: a new tool for innovators?

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As India appears to forge closer trade relations with the US, will the country introduce a data exclusivity legal provision and what impact would this have? LSIPR investigates.

India is one of the world’s largest suppliers of generic drugs, with its plants estimated to manufacture 40% of all generic medicines in the US and 90% of the world’s generic HIV/AIDS medicines. But its approach to intellectual property has sometimes riled innovator companies—and in recent years, businesses including Gilead and Novartis been refused Indian patents for products that are IP-protected in other countries.

Meanwhile, Bayer has been engaged in a long battle to revoke a compulsory licence that lets Indian generic drug makers make and sell the patent-protected cancer drug Nexavar (sorafenib).

Now, big pharma companies are looking for alternative ways to protect their products in the subcontinent—through data exclusivity.

Gilead, Novartis, data exclusivity, WTO, TRIPS, USTR,