India’s Intellectual Property Appellate Board has rejected Bayer’s request for a stay on the compulsory licensed issued for the anticancer drug sorafenib tosylate, (sold by Bayer under the brand name Nexaver). The compulsory license was issued to the generic manufacturer Natco last March under Section 84 of the Indian Patents Act. The controller of patents had found that each of the three necessary conditions applied: “(a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.”
Bayer has appealed the compulsory license, and though its request for a stay of the compulsory license has been rejected, the appeal is ongoing. Reuters reports that the final decision is expected in the next few week.
According to a press release by Médecins Sans Frontières, “the compulsory license brought the price of the patented anti cancer drug, sorafenib tosylate, down from over US$5,500 per month to $175 per month; a price reduction of 97 per cent.” Under the terms of the compulsory license, Natco pays Bayer a 6% royalty on sales.