Forest Laboratories, LLC v. Sigmapharm Laboratories, LLC

          Appeals from the United States District Court for the District of Delaware in Nos. 1:14-cv-01119-MSG, 1:14-cv-01266-SLR-SRF, 1:14-cv-01504-SLR-SRF, 1:15-cv-00158-SLR, 1:15-cv-00430-SLR, Judge Sue L. Robinson.

          Howard Warren Levine, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Washington, DC, argued for plaintiffs-cross-appellants. Also represented by Jonathan Robert Davies, Sanya Sukduang; Charles E. Lipsey, Reston, VA.

          Anthony R. Friedman, The Simon Law Firm, P.C., St. Louis, MO, argued for defendant-appellee. Also represented by Anthony G. Simon.

          Clifford Katz, Kelley Drye & Warren, LLP, New York, NY, argued for all defendants-appellants. Defendant-appellant Breckenridge Pharmaceutical Inc. also represented by Malavika Rao.

          Imron T. Aly, Schiff Hardin LLP, Chicago, IL, for defendants-appellants Hikma Pharmaceuticals LLC, Hikma Pharmaceuticals PLC, Hikma Pharmaceuticals USA Inc. Also represented by Joel M. Wallace.

          Ksenia Takhistova, Hunton Andrews Kurth LLP, New York, NY, for defendants-appellants Alembic Pharmaceuticals Ltd., Alembic Global Holding S.A., Alembic Pharmaceuticals Inc.

          Michael R. Dzwonczyk, Sughrue Mion PLLC, Washington, DC, for defendants-appellants Amneal Pharmaceuticals LLC, Amneal Pharmaceuticals of New York LLC, Amneal Pharmaceuticals Co. India Pvt. Ltd.

          Before Prost, Chief Judge, Dyk and Moore, Circuit Judges.

          MOORE, CIRCUIT JUDGE.

         Sigmapharm Laboratories, LLC, ("Sigmapharm"), Hikma Pharmaceuticals LLC, Hikma Pharmaceuticals PLC, Hikma Pharmaceuticals USA Inc., (collectively, "Hikma"), Breckenridge Pharmaceuticals Inc. ("Brecken-ridge"), Alembic Pharmaceuticals Ltd., Alembic Global Holdings S.A., Alembic Pharmaceuticals Inc., (collectively, "Alembic"), Amneal Pharmaceuticals LLC, and Amneal Pharmaceuticals Co. India Pvt. Ltd. (collectively "Amneal") are drug manufacturers who filed Abbreviated New Drug Applications with the Food and Drug Administration seeking to market generic versions of Saphris, a drug product sold by Forest Laboratories, LLC. Saphris is a sublingually administered, atypical antipsychotic containing asenapine maleate.

         Forest sued for patent infringement, asserting that Appellants' proposed generic products would infringe claims 1-2, 4-6, and 9-10 of U.S. Patent No. 5, 763, 476. The parties have stipulated that the validity of claims 2, 5, and 6 rises and falls with that of claim 1, and the validity of claims 9 and 10 rises and falls with that of claim 4. Forest, Breckenridge, and Alembic have further stipulated that infringement of claims 9 and 10 rises and falls with that of claim 4. Claims 1 and 4 recite:

1. A pharmaceutical composition comprising as a medicinally active compound: trans-5-chloro-2-me-thyl-2, 3, 3a, 12b-tetrahydro-1H-dibenz[2, 3:6, 7]ox-epino[4, 5-c]pyrrole or a pharmaceutically acceptable salt thereof; wherein the composition is a solid composition and disintegrates within 30 seconds in water at 37° C.

4. A method for treating tension, excitation, anxiety, and psychotic and schizophrenic disorders, comprising administering sublingually or buccally an effective amount of a pharmaceutical composition comprising trans-5-chloro-2-methyl-2, 3, 3a, 12b-tetrahydro-1H-dibenz[2, 3:6, 7]oxepino[4, 5-c]pyrrole or a pharmaceutically acceptable salt thereof.

         Trans-5-chloro-2-methyl-2, 3, 3a, 12b-tetrahydro-1H-dibenz [2, 3:6, 7]oxepino[4, 5-c]pyrrole is also known as asenapine. Forest sells an atypical antipsychotic containing asenapine maleate under the name Saphris, which was developed by non-party Organon, another pharmaceutical company. Asenapine was originally developed as a conventional oral tablet. Conventional oral tablets are swallowed and enter into the digestive system before being metabolized. In contrast, Saphris is administered sublingually, meaning the formulation is placed under the tongue, where it dissolves. Buccal administration is similar, but in the cheek cavity.

         Following a bench trial, the district court held Appellants had not established claims 1-2, 4-6, and 9-10 to be invalid and held Forest had not established infringement of claims 4, 9, and 10 as to Alembic and Breckenridge. Appellants appeal the district court's construction of claim 1 and its determination that the claims have not been established to be invalid. Forest cross-appeals, arguing the district court's finding that Breckenridge and Alembic do not infringe claim 4 was clearly erroneous. We have jurisdiction under 28 U.S.C. § 1295(a)(1). We vacate and remand the district court's validity determination, and we vacate and remand for it to reconsider infringement under a corrected claim construction.

         Discussion

         I. Construction of Claim 1

         While claim 4 is expressly limited to sublingual or buccal formulations of asenapine, claim 1 is not and instead states that "the composition is a solid composition and disintegrates within 30 seconds in water at 37° C." The district court nevertheless construed claim 1 to be limited to buccal and sublingual formulations. Appellants argue the district court erred in construing claim 1 this way. We review a district court's ultimate claim construction and its interpretations of intrinsic evidence de novo and any subsidiary fact findings about ...