Amgen Inc. v. Sandoz

The Biologics Price Competition and Innovation Act (BPCIA), governs abbreviated biologics license applications (aBLAs) based on the licensing of a reference product. BPCIA allows patent infringement suits before approval: the applicant provides confidential access to its aBLA. The parties negotiate a list of patents for an immediate infringement action. Under subsection 262(l), the applicant gives notice at least 180 days before commercial marketing, to allow a suit for preliminary injunction. If the applicant discloses information, neither may bring suit based on non-listed patents before notice of commercial marketing. Amgen has marketed Neupogen® since 1991. Sandoz filed an aBLA, for a Neupogen biosimilar. Sandoz notified Amgen that intended to launch its biosimilar upon approval and would not provide its aBLA. In 2015, the FDA approved Sandoz’s aBLA. Sandoz gave notice of commercial marketing. Amgen sued, asserting state law claims of unfair competition based on BPCIA violations; conversion; and patent infringement. The court held that BPCIA permits an applicant not to disclose its aBLA and that the applicant may give notice of commercial marketing before FDA approval. The Federal Circuit affirmed dismissal of Amgen’s state law claims, but directed the court to consider the patent infringement claims. The Supreme Court held that an injunction under federal law is not available to enforce 42 U.S.C. 262(l)(2)(A) and a biosimilar applicant may provide the notice required by 262(l)(8)(A) either before or after FDA approval to start the 180-day clock. The Federal Circuit then affirmed dismissal of the state law claims; Sandoz did not forfeit its preemption defense and the BPCIA preempts state law remedies for failure to comply with section 262(l)(2)(A). View "Amgen Inc. v. Sandoz" on Justia Law