State Law Cannot Circumvent Congress’s Scheme for Biologics

In Amgen v. Sandoz, No. 2015-1499, the Federal Circuit affirmed the Northern District of California’s decision that Sandoz had not waived its preemption defense and that the Biologics Price Competition and Innovation Act of 2009 (BPCIA) preempted Amgen’s state law claims against Sandoz’s abbreviated biologics license application (aBLA) for filgrastim (marketed as Neupogen® by Amgen).

The district court held that (1) Sandoz did not waive its preemption defense, and (2) Amgen’s state law claims were preempted by the BPCIA. The Federal Circuit affirmed the district court’s decision on the state law claims, but vacated the district court’s decision on the preemption defense. The Supreme Court then heard the appeal and held that the BPCIA did not allow injunctions and that notice could be given before or after receiving FDA approval for a biologic, reversing and vacating the Federal Circuit’s decision.

On remand from the Supreme Court, the Federal Circuit affirmed the district court’s decision that Sandoz did not waive the defense because preemption was a matter of public concern, and Sandoz preserved its right to assert a preemption defense in its answer. The Federal Circuit also held that the state law claims were preempted under field preemption because Congress intended to occupy the field of biologic litigation. Further, the state law claims were preempted under conflict preemption because they conflicted with Congress’s “intricate federal scheme” and designated remedies.