The U.S. Supreme Court unanimously decided Sandoz Inc., v. Amgen Inc., on Monday June 12, 2017, construing the Biologics Price Competition and Innovation Act (BPCIA). The Court held:  (1) that the patent dance is not enforceable by injunction under Federal law, and  (2) that a biosimilar applicant’s 180-day “notice of commercial marketing” can be provided before FDA approval. (See Sandoz v. Amgen—Biosimilars at the Supreme Court—Oral Argument.)

Background

The BPCIA provides an abbreviated FDA approval pathway for follow-on biologics (biosimilars and interchangeable biologics). This case arises from Sandoz seeking to market a biosimilar version of Amgen’s NEUPOGEN®.  Sandoz refused to give Amgen a copy of its abbreviated Biologics License Application (aBLA) as part of the BPCIA information exchange known as the “patent dance.”  Sandoz also provided a 180-day notice of commercial marketing before the FDA approved its aBLA.  Amgen sued Sandoz to force compliance with the BPCIA.

On appeal, the Federal Circuit held that the patent dance was optional, but ruled that a biosimilar applicant must provide a notice of commercial marketing to the reference product sponsor after the aBLA is approved, and that the biosimilar applicant must wait 180 days after serving the notice before marketing. The parties sought Supreme Court review.

SCOTUS Decision

1) The “Patent Dance” is Not Mandatory

The Supreme Court held that the patent dance is not mandatory, but that the BPCIA provides a remedy for failure to comply with the steps of the dance: “the sponsor, but not the applicant, [may] bring an immediate declaratory-judgment action for artificial infringement.”

Moreover, the Court noted that Congress did not intend for the aBLA applicant to be enjoined into the patent dance.  But failure to participate may be a factor considered in preliminarily enjoining marketing.

The Supreme Court also ruled that the Federal Circuit did not properly address the merits of a potential state law injunction enforcing the patent dance, and remanded the issue to the Federal Circuit.

2) Notice of Commercial Marketing is Effective Prior to FDA Licensure

Reversing the Federal Circuit, the Court held that the aBLA need not be approved before the notice is served.  In support of its interpretation, the Court contrasted the timing language in the notice provision with other provisions of the BPCIA that contain more than one timing requirement, (e.g. after receiving notice… and before… first commercial marketing”).

Looking Forward

This case addresses several important BPCIA interpretation issues, but numerous other issues remain.  For example, Justice Breyer notes that Chevron deference may well allow the FDA to reinterpret the provisions at issue in this decision.

It will be up to future litigants, (and these parties on remand), to address the remaining issues.