Federal Circuit Clarifies Boundaries of Discovery During Litigation Under the BPCIA

This week, the Federal Circuit issued a much-anticipated precedential decision in Amgen, Inc. v. Hospira, Inc., No. 2016-2179 (Fed. Cir. Aug. 10, 2017), rejecting Amgen’s efforts to compel discovery regarding aspects of Hospira’s biosimilar application relevant to patents Amgen chose not to identify during the “patent dance” established by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). While much of the court’s discussion is dictum, the opinion nonetheless provides important guidance to reference product sponsors regarding what patents can and should be identified under 42 U.S.C. § 262(l)(3)(A). Continue reading

Genband v. Metaswitch Outlines Permanent Injunction Standards for Infringing Sales of Multicomponent Products

This week the Federal Circuit issued its decision in Genband US LLC v. Metaswitch Networks Corp., No. 2017-1148 (Fed. Cir. July 10, 2017) (precedential), which vacated a district court’s order denying a request for a permanent injunction in a case involving two competitors in the telecommunications industry. The opinion synthesizes and clarifies a prior series of rulings regarding the proper standards for evaluating irreparable harm in requests for injunctive relief regarding sales of multicomponent products. Continue reading