First Biosimilars Ruling is Out … Industry, Take Heed!

In a decision of first impression, Judge Maxine M. Chesney of the Northern District of California dismissed Sandoz’s declaratory judgment action against Amgen for lack of jurisdiction. Sandoz had brought its suit on June 24, 2013 seeking a ruling that its biosimilar version of Amgen’s patented arthritis drug Enbrel (etanercept) would not infringe and that the patents are invalid. Amgen moved to dismiss the case for lack of subject-matter jurisdiction or, alternatively, to decline to exercise Declaratory Judgment jurisdiction.