The Federal Circuit recently vacated a district court decision which found a patent for the antipsychotic drug “Saphris,” belonging to Forest Laboratories (Forest), valid as nonobvious, but not infringed by ANDA filers Alembic Pharmaceuticals Ltd. (Alembic) and Breckenridge Pharmaceuticals, Inc. (Breckenridge). See Forest Labs., LLC v. Sigmapharm Labs., LLC, Nos. 2017-2369, 2017-2370, 2017-2372, 2017-2373, 2017-2374, 2017-2375, 2017-2376, 2017-2389, 2017-2412, 2017-2436, 2017-2438, 2017-2440, 2017-2441, 2019 U.S. App. LEXIS 7485 (Fed. Cir. Mar. 14, 2019) (Before Prost, Dyk, and Moore, J.) (Opinion for the court, Moore, J.). The Court highlighted an unanswered question that the district court skimmed over at trial and took issue with a claim construction. The Court vacated and remanded for further proceedings on this basis. Alembic and Breckenridge were among a number of drug manufacturers that filed Abbreviated New Drug Applications (ANDA) to market generic versions of Saphris. Saphris is an antipsychotic containing asenapine maleate. Saphris is administered sublingually, meaning under the tongue. Forest sued the ANDA filers for patent infringement. At trial, the district court held that the relevant claims of asserted Patent No. 5,763,476 (“the ’476 patent”) were not invalid as obvious, and that Forest had not established infringement by Alembic or Breckenridge. Alembic and Breckenridge appealed the invalidity determination, and Forest cross-appealed the non-infringement decision as clearly erroneous. On appeal, the Federal Circuit vacated and remanded both the validity and infringement determinations for reconsideration under a correct claim construction of the term “excitation.”

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