FOREST LABORATORIES, LLC, FKA FOREST LABORATORIES, INC., FOREST LABORATORIES HOLDINGS LTD., Plaintiffs-Cross-Appellants
SIGMAPHARM LABORATORIES, LLC, Defendant-Appellee HIKMA PHARMACEUTICALS LLC, HIKMA PHARMACEUTICALS PLC, HIKMA PHARMACEUTICALS USA INC., FKA WEST-WARD PHARMACEUTICALS CORP., BRECKENRIDGE PHARMACEUTICAL INC., ALEMBIC PHARMACEUTICALS LTD., ALEMBIC GLOBAL HOLDING S.A., ALEMBIC PHARMACEUTICALS INC., AMNEAL PHARMACEUTICALS LLC, AMNEAL PHARMACEUTICALS OF NEW YORK LLC, AMNEAL PHARMACEUTICALS CO. INDIA PVT. LTD., Defendants-Appellants
Appeals from the United States District Court for the
District of Delaware in Nos. 1:14-cv-01119-MSG,
1:15-cv-00158-SLR, 1:15-cv-00430-SLR, Judge Sue L. Robinson.
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.
Clifford Katz, Kelley Drye & Warren, LLP, New York, NY,
argued for all defendants-appellants. Defendant-appellant
Breckenridge Pharmaceutical Inc. also represented by Malavika
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.
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.
Prost, Chief Judge, Dyk and Moore, Circuit Judges.
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.
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.
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.
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.
Construction of Claim 1
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 ...