Amgen, Novartis, Pfizer autoimmune news
U.S. Court of Appeals for the Federal Circuit affirmed a district court’s ruling that a company developing a biosimilar can’t file suit seeking declaratory judgment of non-infringement of patents covering the reference biologic until it has submitted an application for approval of the biosimilar to FDA. In July 2013, Novartis’ Sandoz Inc. generics unit filed the suit in the U.S. District Court for the Northern District of California asking the court to declare that Sandoz’s proposed biosimilar of Enbrel etanercept does not infringe two U.S. patents covering the autoimmune drug. The district court dismissed the suit in November 2013 (see BioCentury, Nov. 18, 2013 & Jan. 20, 2014).
Amgen and Pfizer co-market Enbrel in the U.S. and Canada, while Pfizer has rights elsewhere. Enbrel is approved to treat rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. Amgen reported $3.4 billion in U.S. Enbrel sales for the nine months ending Sept. 30. ...