Biogen’s Best-Selling Drug Loses Patent In EU, Says Cowen
A European court revoked a patent on Biogen ‘s ( BIIB ) multiple-sclerosis drug Tecfidera on Thursday, according to an analyst at Cowen & Co. Eric Schmidt wrote in a brief note Thursday afternoon that a European Union court had revoked European Patent EP2137537, which covered the 480-mg-per-day dose of Tecfidera, which first launched in 2013. The patent, which expires in 2028, is one of four that Biogen holds on Tecfidera in the EU, along with a 10-year period of market exclusivity due to its classification as a “new active substance.” “The U.S. patent equivalent of the ‘537 patent is the ‘514 patent, which is being challenged in an interference proceeding by Forward Pharma ( FWP ),” Schmidt wrote. “While we don’t know the rationale behind the revocation of the ‘537 patent, we assume it also has to do with Forward Pharma, which claims an earlier filing date for a similar invention.” Schmidt wrote that Biogen will probably appeal the decision, which would suspend the revocation for as long as four years as the court battle goes on. If the appeal fails, he estimates that over $1 billion in sales — about a quarter of the worldwide total — will be at risk. Tecfidera is currently Biogen’s top-selling drug, providing a third of revenue last year. The news came out shortly before the close, as Biogen stock followed the rest of the market by rising early but then erasing its gains. It close down 1.4% at 251.97. Forward Pharma closed down 0.8% at 13.17 but was up 6% in after-hours trading.