Amgen Inc. v. Apotex Inc.

Apotex applied to the FDA, under the Biologics Price Competition and Innovation Act of 2009, for permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA-approved Neulasta®. Apotex and Amgen proceeded under the Act’s process for exchanging information and channeling litigation about patents relevant to the application. In this suit, Amgen alleged that Apotex’s proposed marketing would infringe an Amgen patent. On Amgen’s motion, the district court preliminarily enjoined Apotex from entering the market unless it has given Amgen notice after receiving the requested FDA license and then waited 180 days, pursuant to 42 U.S.C. 262(l)(8)(A). The Federal Circuit affirmed. The Act’s commercial-marketing provision is mandatory, with the 180-day period beginning only upon post-licensure notice, and an injunction was proper to enforce the provision against even a biosimilar product​ applicant that did engage in the statutory process for exchanging patent information and channeling patent litigation. View "Amgen Inc. v. Apotex Inc." on Justia Law