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Zuckerman Spaeder Files Supreme Court Amicus Brief Supporting Biosimilar Manufacturer

March 21, 2016

On behalf of the Biosimilars Council, a division of the Generic Pharmaceutical Association, Zuckerman Spaeder partner Carlos Angulo filed an amicus brief in the United States Supreme Court urging the Court to grant the petition for certiorari filed by Sandoz, Inc., in Sandoz v. Amgen.

Sandoz, the manufacturer of a biosimilar version of Amgen’s Neupogen product, has asked the U.S. Supreme Court to review a decision from last year in which the U.S. Court of Appeals for the Federal Circuit held 180-day day “notice of commercial marketing” under the Biosimilars Price Competition and Innovation Act (BPCIA) could only be given after FDA approval, and that notice can be compelled by the reference product sponsor (here, Amgen) through an automatic injunction. The effect of Federal Circuit’s holding, if left undisturbed, would be to delay the marketing of FDA-approved biosimilars by six months, to effectively extend the 12-year market exclusivity period adopted by Congress in the BPCIA, and to enable the reference product sponsor to enforce this additional delay automatically in court.

Our amicus brief argues that Congress did not intend for the notice provision to cause an additional six-month delay in patients’ access to approved biosimilars and that an automatic injunction conflicts with the remedies Congress chose in the BPCIA’s “patent dance” provisions and with well-established standards for the issuance of permanent injunctions. Our brief further argues that the Federal Circuit’s decision jeopardizes Congress’ vision of enormous savings to the U.S. healthcare system and that Supreme Court review is necessary to provide definitive guidance as the biosimilars industry continues to grow.

Whether the Court takes this case, and what it decides if it does, will shape the landscape for the biosimilars industry for years to come.

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