You Can't 'Patent Dance' Your Way Out Of Biosimilar Notice

Law360, New York (July 7, 2016, 11:57 AM EDT) -- Tasha M. Francis

Jenny A. Shmuel On July 5, 2016, the Federal Circuit issued its decision in Amgen Inc. v. Apotex Inc. affirming the district court’s ruling that notice of commercial marketing under the Biologics Price Competition and Innovation Act is only effective after U.S. Food and Drug Administration approval of a biosimilar, even when the parties engage in the so-called “patent dance.” This is the second panel of the Federal Circuit to interpret the BPCIA as requiring notice after FDA licensure, dealing a blow to biosimilar applicants who could otherwise launch their biosimilar products immediately after FDA approval.

This case resolves an...

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