Even as the Government is actively considering the proposal of allowing compulsory licence (CL) for three more cancer drugs, another Indian company has filed an application for the compulsory licence for an anti-cancer drug patented by pharma major Bristol Myers Squibb.
The application, the second such in India so far, has been filed by Maharashtra-based BDR Pharmaceuticals for selling cancer drug Dasatinib. BMS sells Dasatinib at around Rs.1,68,000 per month, but BDR has promised to sell it at Rs.8100, it learnt.
The first application for CL was the one filed by Natco Pharma to sell the cheaper version of Bayer AG’s cancer Drug Nexavar, triggering a highly-watched legal battle. The Indian company was granted the CL in an epoch-making verdict last year and the ruling was recently upheld by the IPAB recently.
The application also comes at a time when a Government panel is examining the issue of allowing compulsory licences in three more drugs - Trastuzumab, Ixabepilone and Dasatinib. The proposal, originally suggested by Health Ministry and the Department of Industrial Policy and Promotion has formed the panel to look into it. The Department of Pharmaceuticals (DoP) had also been asked to give its comments on the issue. All these three drugs are priced above one lakh. Interestingly, BMS has the patent also to Ixabelpilone apart from Dasatinib. Trastuzumab is manufactured by Roche.
BDR Pharmaceuticals had approached BMS for a license in early 2012, but BMS sought extensive and elaborate set of documentation/ facts. BDR then sent notice to the patent office, claiming that BMS was not interested in granting the licence and the information asked for was nothing more than a delay tactic. After treating it as a refusal by BMS, the Indian company has now moved the authorities for CL.
The proposal by the Health Ministry is to invoke the rule Sec 92 of the Indian Patent Act through under which the government can issue a compulsory licence on certain patents notified in the gazette. After the same is notified by the government, any company interested in its manufacture is allowed approach the patent controller for a licence.