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Shire Development, LLC v. Watson Pharmaceuticals, Inc.

United States Court of Appeals, Federal Circuit

February 10, 2017

SHIRE DEVELOPMENT, LLC, SHIRE PHARMACEUTICAL DEVELOPMENT, INC., COSMO TECHNOLOGIES LIMITED, GIULIANI INTERNATIONAL LIMITED, NKA NOGRA PHARMA LIMITED, Plaintiffs-Appellees
v.
WATSON PHARMACEUTICALS, INC., NKA ACTAVIS, INC., WATSON LABORATORIES, INC. - FLORIDA, NKA ACTAVIS LABORATORIES FL, INC., WATSON PHARMA, INC., NKA ACTAVIS PHARMA, INC., WATSON LABORATORIES, INC., Defendants-Appellants

         Appeal from the United States District Court for the Southern District of Florida in No. 0:12-cv-60862-DMM, Judge Donald M. Middlebrooks.

          EDGAR Haug, Frommer Lawrence & Haug LLP, New York, NY, argued for plaintiffs-appellees. Also represented by Elizabeth Murphy, Erika Selli, Jason Aaron Lief, Andrew S. Wasson.

          Steven Arthur Maddox, Maddox Edwards, PLLC, Washington, DC, argued for defendants-appellants. Also represented by Jeremy J. Edwards, Kaveh Saba.

          Before Prost, Chief Judge, TARANTO and HUGHES, Circuit Judges.

          Hughes, Circuit Judge.

         Plaintiffs (collectively, Shire) sued Defendants (collectively, Watson) for infringing claims 1 and 3 of U.S. Patent No. 6, 773, 720 by filing Abbreviated New Drug Application No. 203817 with the Food and Drug Administration seeking to market a generic version of Shire's mesalamine drug, LIALDA®. Because Watson's ANDA Product does not satisfy the Markush group requirements in claim 1(b), we reverse and remand with instructions to enter judgment of non-infringement.

         I

         A

         The '720 patent is directed to a controlled-release oral pharmaceutical composition of mesalamine (also known as mesalazine or 5-amino-salicylic acid) used to treat certain inflammatory bowel diseases. Shire Dev., LLC v. Watson Pharm., Inc., 787 F.3d 1359, 1361 (Fed. Cir. 2015) (2015 Decision). That composition includes the mesalamine active ingredient; an inner, lipophilic matrix; an outer, hydrophilic matrix; and other optional excipients. '720 patent col. 2 11. 36-44.

         When a matrix is hydrophilic, it "has an affinity for water" and therefore "readily dissolves in" it. 2015 Decision, 787 F.3d at 1362 n.l; see Shire Dev. LLC v. Watson Pharm., Inc., No. 12-60862-CIV, 2016 WL 1258885, at *6 (S.D. Fla. Mar. 28, 2016) (2016 Trial Decision) (noting the parties' stipulated-to definition of "hydrophilic" as "having an affinity to water"). Conversely, when a matrix is lipophilic, it "has an affinity for lipids" and therefore "resists dissolving in water." 2015 Decision, 787 F.3d at 1362 n.l; see id. at 1365 (noting the parties' stipulated-to definition of "lipophilic" as "poor affinity towards aqueous fluids").

         Shire asserts claims 1 and 3 of the '720 patent. In relevant part, claim 1 reads:

1. Controlled-release oral pharmaceutical compositions containing as an active ingredient 5-amino-salicylic acid, comprising:
a) an inner lipophilic matrix consisting of substances selected from the group consisting of unsaturated and/or hydrogenated fatty acid, salts, esters or amides thereof, fatty acid mono-, di- or triglycerids, waxes, ceramides, and cholesterol derivatives with melting points below 90° C, and wherein the active ingredient is dispersed both in said [sic] the lipophilic matrix and in the hydrophilic matrix;
b) an outer hydrophilic matrix wherein the lipophilic matrix is dispersed, and said outer hydrophilic matrix consists of compounds selected from the group consisting of polymers or copolymers of acrylic or methacrylic acid, alkylvinyl polymers, hy-droxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, ...

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