On July 21, 2015, in Amgen Inc. v. Sandoz Inc., the US Court of Appeals for the Federal Circuit affirmed in part, and vacated and remanded in part, the US District Court for the Northern District of California's decision (No. 2015-1499, (Fed. Cir. July 21, 2015)). The Federal Circuit agreed with the district court that a biosimilar applicant under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) is not required to disclose its abbreviated biologics license application (aBLA) and manufacturing information to the reference product sponsor (RPS) within 20 days of the FDA's acceptance of the aBLA. The Federal Circuit's decision allows biosimilar applicants to avoid the "patent dance" contemplated by the BPCIA, a strategy used by several aBLA applicants in recent litigations.

The case involved Neupogen, a biologic filgrastim product that Amgen Inc. has marketed since 1991. In May 2014, Sandoz Inc. filed an aBLA for a biosimilar product that would compete with Neupogen, as provided for by 42 U.S.C § 262(k). In July 2014, the FDA accepted Sandoz's aBLA for review and Sandoz immediately notified Amgen that:

Shortly thereafter, Sandoz refused to provide Amgen with Sandoz's aBLA and manufacturing information for its product. When the FDA approved Sandoz's aBLA on March 6, 2015, Sandoz gave Amgen further notice of Sandoz's intent to launch its biosimilar product.

In October 2014, Amgen sued Sandoz, asserting claims of:

In response, Sandoz counterclaimed for a declaratory judgment that its actions were permitted under the BPCIA and that the '427 patent was invalid and not infringed. In January 2015, the parties filed cross-motions for judgment on the pleadings and Amgen also filed a motion for a preliminary injunction to enjoin Sandoz from launching its biosimilar product until after FDA approval.

The district court granted partial judgment to Sandoz on its BPCIA counterclaims and dismissed Amgen's state law claims, concluding that Sandoz did not violate the BPCIA. The district court found that:

On appeal, the Federal Circuit affirmed the district court's holding regarding Sandoz's failure to disclose its aBLA and manufacturing information, explaining that the BPCIA expressly contemplates the scenario where an aBLA applicant refuses to provide this information within 20 days after receiving notice of the FDA's acceptance of the aBLA. Specifically, under 42 U.S.C § 262(l)(9)(C), the only remedies under the BPCIA are those based on a claim of patent infringement when an aBLA applicant refuses to provide this information within the deadline.

With respect to Sandoz's notice of commercial marketing, the Federal Circuit reversed the district court, holding that the FDA must approve the aBLA in question before the aBLA applicant can provide effective notice of its intent to commercially market the generic biologic product (see 42 U.S.C § 262(l)(8)(A)). The court supported its interpretation by noting that the purpose of the notice requirement is to give the RPS time to assess and act upon its patent rights. Accordingly, the court held that:

The Federal Circuit also affirmed the dismissal of Amgen's conversion claims and deemed its motion for preliminary injunction moot. Amgen's infringement claims are still pending in district court at the time of the Federal Circuit's decision.

Judges Newman and Chen issued separate opinions concurring in part and dissenting in part. Judge Newman would have held that the BPCIA requires Sandoz to disclose its aBLA and manufacturing information within 20 days of the FDA's acceptance of Sandoz's aBLA. Judge Chen would have held that the 180 day notice of commercial marketing requirement is inapplicable when an aBLA application refuses to provide the application and manufacturing information within 20 days after the FDA's acceptance of the application.