Indian generic drug maker BDR Pharma's plans could draw new battles lines over intellectual property rights. After seeking a compulsory license for leukemia drug Sprycel, BDR Pharma is setting its sight on more patent-protected anti-cancer drugs, reports CNBC-TV18's Archana Shukla.
BDR is not stopping at just one compulsory license application. Sources say that the company is preparing to file its second license now. This time it is for BMS breast cancer drug Ixempra.
The company is likely to file and submit their application to the patent office by the end of next week. It is believed to be offering a price at 90 percent discount to the current selling price of Ixempra, which is at around Rs 80,000 per vial. This grounds on which BDR is seeking a compulsory license are unaffordable price as well as non-availability of the drug in the Indian market.
Sources also say that the company is preparing to file another compulsory license application for Herceptin. Right now there are a lot of regulatory hurdles yet to be cleared in terms of lack of approval pathway for generic biotech drugs. Once those are cleared the company is believed to be ready with its application to seek a compulsory license for Herceptin.
BDR's moves are certain to open new battle fronts over IP rights. Just two weeks back, Intellectual Property Appellate Board ruled against Bayer's appeal against India’s first compulsory license order given to Natco for Bayer's kidney cancer drug Nexavar. This was opposed by multinationals.
On the other hand, DIPP's intent to grant compulsory license for Sprycel, Ixempra and Herceptin has already been opposed by MNCs across the globe and also by the US trade representatives. In fact, just last week Pfizer made a presentation to the US congress criticizing India's compulsory licensing norms. So any new application will fuel this fire and BDR is the one who's making the first moves.