In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), the CAFC affirmed the district court’s interpretation of the “information exchange” provision of BPCIA and partially reversed the district court’s decision regarding the “notice provision,” holding that the 180-day notice of commercial marketing provision of BPCIA is ineffective unless it is provided after a biosimilar applicant receives FDA licensure. This was the Federal Circuit’s first real opportunity to interpret provisions of BPCIA.
This decision was vacated in part, reversed in part, and remanded by SCOTUS in Sandoz Inc. v. Amgen Inc., 137 S. Ct. 1664 (2017). The Court held that the notice of commercial marketing could be provided by the applicant either before or after receiving FDA approval. The Court did affirm the “information exchange” requirement is not enforceable by injunction, but for different reasons than the CAFC. The Court remanded for a determination as to whether an injunction is available under state law.
In Amgen Inc. v. Sandoz Inc., 877 F.3d 1315 (Fed. Cir. 2017), the CAFC, on remand from SCOTUS, held that Sandoz had not waived its preemption defense and that Amgen’s state law claims were preempted by BPCIA with regard to Sandoz’s aBLA for filgrastim. The court held that the defense was not waived because it was a matter of public concern and Sandoz had preserved the defense in its answer. The court also held that Amgen’s state law claims were preempted under field preemption and conflict preemption.