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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.
Life Sciences Intellectual Property Review (LSIPR) tracks the increasing challenges for intellectual property specialists in the rapidly evolving world of life sciences. From gene patents to stem cell research, we provide the very best news and analysis.
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Gilead, Novartis, data exclusivity, WTO, TRIPS, USTR,
