BioCentury
ARTICLE | Politics & Policy

Court: biosimilar sponsors can't preemptively sue

November 15, 2013 2:02 AM UTC

A judge in the U.S. District Court for the Northern District of California ruled 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 June, the Sandoz Inc. generics unit of Novartis AG (NYSE:NVS; SIX:NOVN) filed suit against Amgen Inc. (NASDAQ:AMGN) 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 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. Sandoz's proposed biosimilar of Enbrel is in an international Phase III trial for moderate to severe chronic plaque-type psoriasis. ...