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The Vexed Issue of Linking Regulatory Approval of Drugs to their Patent Status
Public Interest in pharma patent litigation got a shot in the arm again. In an earlier instance, the elaborate judgment of the Delhi High Court in the ‘Tarceva Case’ between F. Hoffman-La Roche and Cipla Ltd. also factored in public interest in not granting injunction to Roche.
According to a news report, Delhi High Court has allowed the Cancer Patients Aid Association (CPAA) to join the Bayer AG and Cipla Case. The German drug-maker has called into question the approval of Drug Controller General of India (DCGI) granted to Cipla to market the generic version of its patented cancer drug Nexavar. However, the Court in its order clarified that its order is limited only to the drug which is the subject matter of the suit and should not be interpreted for all similar marketing generic applications. The Bayer AG – Cipla Ltd case has touched a raw nerve on the subject matter of linking drug regulation with patents. The matter has got worsened, according to a news report, with Delhi High Court in its interim order last month, asking the DCGI not to grant marketing approval to Cipla for its generic version of the Bayer’s patented drug Naxavar. In this backdrop the Indian Pharmaceutical Alliance has asked the government to clarify its stand on the vexed issue. The next hearing of the Bayer AG – Cipla Case is slated to be heard in the second week of February 2009. The presence of CPAA in the fray is surely going to bring up issues relating to affordability of medicines. In this context, as per the news report, the Organisation of Pharmaceutical Producers of India (OPPI) has a very pertinent point. It says that, ‘Patent Protection’ and ‘Affordability of Medicines’ are two different things. The responsibility of the government to improve access to affordable medicines is at the same plane as to the responsibility of honouring the patent protection granted by it. Violation of a patent is not the desirable way to improve access to affordable medicines to common people. ![]() |