Bayer AG Loses Nexavar Compulsory License Battle

Generic drug makers and disadvantaged patients are the winners here, because India’s Intellectual Property Appellate Board rejected a petition from Bayer on Friday that sought a stay on an order of Controller of Patents. What this now means is that the Hyderabad-based Natco Pharma Limited, a generic drug company, can act on its compulsory license for Bayer’s kidney and liver cancer drug Nexavar. Natco received the first compulsory license ever to make a generic version of Bayer’s Nexavar back in March. In May, Bayer challenged this move. This decision only covers domestic distribution, and was based on the Bayer drug being too expensive to most patients. The Nexavar price is expected to drop from $5,500 per person each month to $175, a 97 percent decline. The drug generated $934 million in global sales in 2010, according to India’s Patent Office, which also noted, however, that Nexavar was barely sold in India and called this “neglectful.” Under the World Trade Organization’s TRIPS Agreement, which governs trade and intellectual property rules, compulsory licenses are a legally recognized means to overcome barriers in accessing affordable medicines.