India, on Wednesday, conveyed to the U.S. that it had not violated any multilateral trade agreement by issuing compulsory licence for Bayer’s patented anti-cancer drug Nexavar to a local firm so as to make it affordable.

It also asserted that such a move should not be seen as routine by the U.S.

The message was conveyed by Commerce and Industry Minister Anand Sharma to U.S. Under Secretary for Economic Growth, Energy and Environment Rober Hormats, who raised concerns over the matter during a meeting here, according to an official.

Mr. Sharma has assured him that the move was totally compliant with multilateral agreements. The compulsory licence (CL) was issued after a due adjudication process, so it should not be seen as routine,” the official added.

In March last, Hyderabad-based Natco Pharma was allowed to manufacture and sell cancer-treatment drug Nexavar at a price that was just a fraction of that was charged by patent-holder Bayer Corporation, under CL. The German firm has already filed an appeal against the Indian Patents Office’s order with the Intellectual Property Appellate Board.

Mr. Hormats raised the U.S. pharmaceutical industry’s concern over issuance of CL by India and said that patent holders should be assured that it should not be a routine thing, the official said.

“The Minister informed him that India is a responsible state and it will not do anything which will hamper innovation in the pharma sector,” the official added.

As per the WTO agreement, a CL can be invoked by a national government, allowing someone else to produce a patented product or process without the consent of the patent owner in public interest.

Drug price

Natco was allowed to sell the drug at a price not exceeding Rs.8,880 for a pack of 120 tablets required for a month’s treatment as compared to a whopping Rs.2.80 lakh charged by Bayer for its patented Nexavar drug.

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