In a case involving the interpretation of the Biologics Price Competition and Innovation Act involving the procedures for seeking FDA approval of biosimilar drugs, the Federal Circuit affirmed the district court’s decision to dismiss Amgen’s state law claims of unfair competition and conversion because Sandoz did not violate the information disclosure and the notice or commercial marketing provision of the BPCIA and vacated the judgment on Sandoz’s declaratory judgment counterclaims and remanded for further proceedings.  In so doing, the Federal Circuit held that an applicant for a biosimilar product may only give effective notice of commercial marketing after the FDA has licensed its product and held that, where the applicant completely fails to provide its aBLA and the required manufacturing information by the statutory deadline, the applicant cannot market its product for 180 days. 

Amgen Inc. v. Sandoz Inc., Case No. 2015-1499 (July 21, 2015); Opinion by: Lourie; Newman, concurring in part and dissenting in part; Chen, dissenting in part; Appealed From: District Court for the Northern  District of California, Seeborg, J. Read full opinion here.

Jump to Page