Amgen, Novartis, Pfizer autoimmune news
Last month, Novartis' Sandoz Inc. generics unit filed an appeal in the U.S. Court of Appeals for the Federal Circuit of 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. Sandoz declined to comment, and Amgen did not respond in time for publication.
Sandoz filed suit against Amgen in June 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. In November, the court dismissed Sandoz's suit and agreed with Amgen's argument that under federal regulations covering biosimilars, Sandoz must meet requirements that include submitting an application for its biosimilar to FDA. Sandoz had argued that it did not need to meet the requirements because it had provided "notice of commercial marketing," but the judge ruled that this notice can only be provided for a licensed product. The suit is Sandoz Inc. v. Amgen Inc. (see BioCentury, Nov. 18, 2013). ...