Who Can Be A Defendant In Biosimilar Patent Litigation?

Can a party that did not submit an abbreviated biologics license application or an abbreviated new drug application, but will market the biosimilar or generic product after U.S. Food and Drug Administration approval, be sued for patent infringement or for a declaratory judgment alleging future infringement?

This question is pending before the U.S. District Court for the District of New Jersey in Amgen Inc. v. Adello Biologics LLC, where co-defendants Amneal Pharmaceuticals LLC and Amneal Pharmaceuticals Inc. seek dismissal, alleging that Amgen failed to state a claim under Federal Rule of Civil Procedure 12(b)(6) and further, because subject matter jurisdiction is lacking under FRCP 12(b)(1).¹