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March 02, 2021

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March 01, 2021

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Biosimilars: New Developments in Amgen v. Apotex

Apotex petitioned the Supreme Court for a writ of certiorari on September 9, 2016, seeking review of the following two issues: (1) “[w]hether the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the BPCIA for the resolution of patent disputes . . . must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A)”; and (2) “[w]hether the Federal Circuit improperly extended the statutory 12-year exclusivity period to [12.5] years by holding that a biosimilar applicant cannot give effective notice of commercial marketing . . . until it receives [FDA approval].” The Supreme Court denied the petition on December 12, 2016, without comment.

However, the questions Apotex presented are narrower than the cross-petitions taken from Amgen Inc. v. Sandoz Inc., 794 F.3d 1347 (Fed. Cir. 2015), which remain pending before the Supreme Court. The Court sought the opinion of the Solicitor General concerning the Sandoz petitions, and in an amicus brief filed on December 7, 2016, the Solicitor concluded that the Court should hear the case. If the Court agrees, it may address Apotex’s questions in the course of deciding Sandoz. Meanwhile, biosimilar applicants and other interested parties should continue to watch the Sandoz petitions and take any decisions into account in developing strategies.

Copyright 2020 K & L GatesNational Law Review, Volume VI, Number 355



About this Author

Margaux L. Nair, KL Gates, Intellectual property Litigator, Chemical Patents Attorney

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...

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

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


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

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


  • Bar of New Jersey

  • Not Admitted in New York


  • ...
Trevor M. Gates, KL Gates, Pharmaceutical Industry Lawyer, Technology Transactions attorney

Trevor Gates is an associate in the firm’s Seattle office. His two main areas of practice are Technology Transactions and Pharma and BioPharma Litigation. 


  • J.D., University of Oregon School of Law, 2015, (Managing Editor, Oregon Law Review, Overall Best Brief and Second-Place Oral Advocacy, National Tax Moot Court Competition)

  • B.S., Western Oregon University, (magna cum laude, Chemistry)


Peter Giunta, KL Gates, pharmaceuticals biotechnology attorney, medical devices lawyer

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...