Roche Renounces Indian Patent for Cancer Drug
Swiss pharmaceutical company Roche Holding AG has announced that it decided to give up its Indian patent for Trastuzumab, a drug marketed under the brand name Herceptin for treatment of an aggressive form of breast cancer. Roche originally held the Herceptin patent until 2019 on annual renewal basis, but has allowed the renewal deadline in May to lapse. According to Roche, the decision took into consideration "the strength of the particular rights and the IP environment in India in general".
Over the past year multinational pharma companies have faced considerable setbacks in India, with several drug patents being revoked by Indian authorities on the grounds of merely improvements on existing inventions rather than fresh innovations. Among them was Roche's patent for hepatitis C drug Pegasys. Meanwhile, Indian patient rights groups have been active, advocating the issuance of compulsory licences and development of generic drugs domestically, in order to bring down the prices of those patented life-saving drugs to make them accessible to the massive deprived population in India.
The first-ever compulsory licence in India was issued last March, thereby granting the right to a local company Natco to make and sell a generic version of Nexavar, Bayer Group's patented drug for liver and kidney cancer treatment. Sources said that Herceptin was once placed under consideration for compulsory licencing. Such idea, however, was dropped eventually because no company in local market had yet been ready to turn out generic equivalents of Herceptin.
As a matter of fact, subsequent to the Nexavar compulsory licence case in August 2012, Roche already introduced a lower-cost version of Herceptin in collaboration with an Indian firm Emcure Pharmaceutics. In the immediate absence of any biosimilars, Roche is expected to be capable of maintaining its market dominance in India for Herceptin for some years ahead in spite of its renunciation of the Herceptin patent.
