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Sandoz v. Amgen – Biosimilars at the U.S. Supreme Court

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.

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Copyright 2020 K & L GatesNational Law Review, Volume VII, Number 187
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About this Author

Kenneth C. Liao, KL Gates, Commercial Licensing Licensure Lawyer, Intellectual property Attorney
Associate

Mr. Liao is an associate in the firm’s New York office, where he is a member of intellectual property practice group.

Education

  • J.D., Fordham University School of Law, 2014

  • B.A., New York University, 2007, (cum laude)

Admissions

  • Bar of New Jersey

  • Not Admitted in New York

Languages

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212-536-4072
Margaux L. Nair, KL Gates, Intellectual property Litigator, Chemical Patents Attorney
Associate

Margaux Nair is a registered patent attorney in the firm’s Chicago office. She has a background in biology, including a familiarity with plant genetics and biochemistry as well as research experience with plant structures and chemical responses to herbivory. 

She focuses her practice on intellectual property matters. She has been involved with the prosecution of applications for a wide range of technologies, including inventions in the life sciences and biotechnology, such as food chemistry innovations, stem cells, genetic innovations and...

312-807-4280
Peter Giunta, KL Gates, pharmaceuticals biotechnology attorney, medical devices lawyer
Partner

Mr. Giunta has over a decade of experience advising clients on intellectual property issues and successfully litigating significant patent cases. He advises clients on a wide array of technologies, including pharmaceuticals, biotechnology, medical devices, and electronics. 

Mr. Giunta has extensive experience handling Hatch-Waxman pharmaceutical patent litigation and related patent opinion, prosecution, and licensing strategies, helping clients navigate the interface between the patent and FDA laws. He has litigated cases involving...

212-536-3910
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