Amgen Inc. has asked a Delaware federal judge to temporarily block Hospira Inc. from bringing a biosimilar version of its anemia-fighting drug Epogen to market, saying the competitor failed to provide the company proper notice under a 2010 law.
According to Amgen’s attorneys, the case is “one of the first” patent infringement suits in the nation brought under a statute enacted as a part of the Biologics Price Competition and Innovation Act. The landmark legislation, part of the Affordable Care Act, established a new abbreviated pathway for the U.S. Food and Drug Administration approval of drugs that are exceptionally similar to licensed, innovative products already being sold on the market.
