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This case involved a dispute over the meaning of the 42 U.S.C. § 262(l)(8)(A) notice provision involving companies seeking to obtain “biosimilar-product” licenses from the FDA.  Amgen successfully obtained a preliminary injunction enjoining Apotex from entering the market unless Apotex gave Amgen notice after receiving the requested FDA license and then waited 180 days.  The district court agreed with Amgen that the Section 262(l)(8)(A) notice requirement is mandatory and enforceable by injunction even for an applicant like Apotex that gave the Section 262(l)(2)(A) notice to launch the information-exchange process leading to the paragraph patent infringement suit. 

The Federal Circuit affirmed, holding that an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before commercial marketing begins, regardless of whether the applicant provided the Section 262(l)(2)(A) notice of FDA review.  

Amgen Inc. v. Apotex, Inc., Case No. 2016-1308 (July 5, 2016); Opinion by: Taranto, joined by Wallach and Bryson; Appealed From: United States District Court for the Southern District of Florida, Shadur, J.  Read the full opinion here.

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