Docket No. 2014-1693
PROST, REYNA, HUGHES
December 5, 2014
Brief Summary: DC decision of no Article III case or controversy affirmed because Sandoz had not yet filed for approval of its biosimilar to Amgen’s Enbrel®.
Summary: Sandoz appealed DC dismissal of its DJ action related to a “biosimilar” to Amgen’s Enbrel® because “Sandoz had not (as it still has not) filed an application for approval” by the FDA under the Biologics Price Competition and Innovation Act (BPCIA) (i.e., no Article III controversy). The DC decided “that, because Sandoz planned to enter the market by the biosimilarity route, it had to follow the BPCIA’s patent-related procedures applicable to biosimilarity applicants-which it had not done.” In its opinion, the FC considered the “justiciability problem[s]” addressed by MedImmune (US 2007) (“sufficient immediacy and reality to warrant the issuance of a declaratory judgment”; “standing and ripeness, as well as mootness, serve as ‘helpful guides in applying the all-circumstances test’”). The FC panel concluded there was no Article III case or controversy at this point (citing Telectronics, FC 1992 (no case or controversy where product “had only recently begun clinical trials, and was years away from potential FDA approval”)) and did “not address distinct questions that may arise as Sandoz continues its efforts to develop and obtain approval”. Thus, the DC decision was affirmed.