The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether or not a biosimilar applicant has elected to initiate the “patent dance,” i.e., the statutory patent information exchange and litigation procedure provided in the statute. The decision in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016) is a key victory for Amgen in its ongoing litigation with Apotex over Apotex’s attempt to obtain FDA approval to market a biosimilar version of Amgen’s biologic Neulasta® (pegfilgrastim). Apotex’s biosimilar application, which was filed in October 2014, remains under FDA review, and the parties are embroiled in patent infringement litigation stemming from Apotex’s filing of that biosimilar application. The decision here has major implications for the emerging US biosimilar industry.