A U.S. Federal Circuit Court finds that the district court exceeded its authority in shortening the statutory stay of entry by a generic competitor which was challenged by a pharmaceutical patent-holder manufacturer in a patent infringement suit (Andrx / Biovail)

Judges: Dyk (author), Bryson, and Linn In Andrx Pharmaceuticals, Inc. v. Biovail Corp., No. 01-1650 (Fed. Cir. Jan. 17, 2002), the Federal Circuit vacated and remanded a lower court’s order (1) shortening the statutory thirty-month delay of FDA approval of Andrx Pharmaceuticals, Inc.’s (“Andrx”) Abbreviated New Drug Application (“ANDA”), and (2) ordering that the FDA approve the ANDA. Under the Hatch-Waxman Amendments, a pioneer drug manufacturer having an approved New Drug Application (“NDA”) must notify the FDA of all patents claiming the drug covered by the NDA. The FDA lists these patents in the “Orange Book.” A generic drug manufacturer can submit an ANDA, as opposed to a full NDA, if the manufacturer can show the generic drug’s bioequivalence with an

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Maria T. Bautista, A U.S. Federal Circuit Court finds that the district court exceeded its authority in shortening the statutory stay of entry by a generic competitor which was challenged by a pharmaceutical patent-holder manufacturer in a patent infringement suit (Andrx / Biovail), 31 July 2001, e-Competitions Bulletin Competition in the Pharmaceutical sector, Art. N° 53010

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