Amgen, Inc. v. Sandoz, Inc., No. 15-1499 (Fed. Cir. 2015)
Annotate this CaseUnder the Biologics Price Competition and Innovation Act (BPCIA), 124 Stat. 119, an abbreviated biologics license application (aBLA) requires proof that a product is “biosimilar” to an approved reference product, plus information regarding the FDA’s determination that the reference product is safe. ABLA approval may not take effect until 12 years after licensing of the reference product. BPCIA allows patent infringement suits before approval: the applicant provides confidential access to its aBLA within 20 days after the FDA accepts its application. The parties negotiate a list of patents that would be subject to 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 that it “opted not to provide” its aBLA, so that Amgen was entitled to sue under section 262(l). In 2015, the FDA approved Sandoz’s aBLA. Sandoz gave a “further notice” of commercial marketing. Amgen sued, asserting state law claims of unfair competition based on BPCIA violations; conversion for wrongful use of Amgen’s approved license; and patent infringement. The court held that BPCIA permits an applicant not to disclose its aBLA; that such a decision alone does not permit the reference product owner to obtain relief; 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 otherwise vacated and directed the court to consider the patent infringement claims.
The court issued a subsequent related opinion or order on December 14, 2017.
Subsequent History
- Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. Jun. 12, 2017)
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