Nathan A Adams IV is a Partner in our Tallahasse office.
In Amgen, Inc. v. Sandoz, Inc., 877 F. 3d 1315 (Fed. Cir. 2017), the court dismissed the plaintiff's unfair competition and conversion claims as pre-empted by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In May 2014, the defendant filed an abbreviated biologics license application (aBLA), seeking FDA approval of a biosimilar filgrastim product, for which Neupogen was the reference product. Sandoz received notification from the FDA that it had accepted the plaintiff's application for review on July 7, 2014, whereupon the defendant notified the plaintiff that it had filed the application and of its plan to launch its biosimilar product upon FDA approval. The plaintiff sued the defendant for unfair competition, conversion and patent infringement, claiming that the defendant violated the BPCIA by failing to disclose its aBLA or its product's manufacturing information and by giving a premature, ineffective notice of commercial marketing before FDA approval. The defendant counterclaimed for a declaratory judgment that BPCIA permitted its actions, that the plaintiff's state law claims were pre-empted and that its patent was invalid. The defendant also asserted the affirmative defense of pre-emption in its answer. The court determined that there was both field pre-emption and conflict pre-emption. Pursuant to the former, state law is pre-empted where it regulates conduct in a field that Congress intended the federal government to occupy exclusively. The court ruled that the BPCIA's "comprehensive, carefully calibrated 'scheme of federal regulation ... [is] so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it.'" Conflict pre-emption occurs when state law conflicts with federal law. The court ruled that there was conflict pre-emption because the plaintiff would, through state law, impose penalties intentionally left unavailable under the BPCIA.
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