SHIRE DEVELOPMENT, LLC, SHIRE PHARMACEUTICAL DEVELOPMENT, INC., COSMO TECHNOLOGIES LIMITED, GIULIANI INTERNATIONAL LIMITED, Plaintiffs-Appellees
WATSON PHARMACEUTICALS, INC., nka ACTAVIS, INC., WATSON LABORATORIES, INC. FLORIDA, 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. 12-CV-60862, JudgeDonald M. Middlebrooks.
EDGAR HAUG, Frommer Lawrence & Haug LLP, New York, NY, for plaintiffs-appellees. Also represented by NICHOLAS F. GIOVE, JONATHAN HERSTOFF, ELIZABETH MURPHY, JOSEPH SAPHIA, ERIN A. LAWRENCE, JASON AARON LIEF, CAROLINE BERCIER, ANDREW S. WASSON.
STEVEN ARTHUR MADDOX, Maddox Edwards, PLLC, Washington, DC, for defendants-appellants. Also represented by JEREMY J. EDWARDS; NEIL MICHAEL MCCARTHY, Knobbe, Martens, Olson & Bear, LLP, Washington, DC.
Before PROST, Chief Judge, CHEN[*] and HUGHES, Circuit Judges.
Hughes, Circuit Judge.
This case returns to us on remand from the Supreme Court. In Shire Development, LLC v. Watson Pharmaceuticals, Inc., 746 F.3d 1326 (Fed. Cir. 2014), we decided an appeal by defendant-appellants (collectively, Watson) from a decision of the United States District Court for the Southern District of Florida. The district court found, among other things, that Watson infringed plaintiffs-appellees' (collectively, Shire's) patent under the district court's constructions of the asserted claims. We reversed the district court's constructions of two claim terms and remanded for further proceedings.
Following our decision in this case, the Supreme Court issued Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 190 L.Ed.2d 719 (2015), which clarified how this court should review a district court's construction of a claim term. The Court also vacated and remanded our Shire decision for further consideration in light of this new standard of review. Shire Dev., LLC v. Watson Pharms., Inc., 135 S.Ct. 1174, 191 L.Ed.2d 130 (2015). Because this case does not involve factual findings to which we owe deference under Teva, we again reverse the district court's constructions of the disputed claim terms and subsequent findings of infringement, and remand for further proceedings.
Shire owns U.S. Patent No. 6,773,720, which claims a controlled-release oral pharmaceutical composition for treating inflammatory bowel diseases. Shire markets these oral pharmaceutical compositions under the brand name LIALDA® . After Watson submitted an Abbreviated New Drug Application (ANDA) seeking approval to sell the bioequivalent of LIALDA®, Shire sued for infringement of the '720 patent. After construing certain relevant claim language, the district court found that Watson's product infringed the '720 patent.
The '720 patent--entitled " Mesalazine Controlled Release Oral Pharmaceutical Composition" --concerns controlled-release oral pharmaceutical compositions for treating inflammatory bowel diseases, such as Crohn's disease and ulcerative colitis. '720 patent col. 1 ll. 9-13. The active ingredient in these compositions is 5-aminosalicylic acid, which is also known as mesalazine or mesalamine (hereinafter, mesalamine). Mesalamine treats inflamed areas in the bowel by direct contact with the intestinal mucosal tissue. J.A. 9054. Thus, mesalamine must pass through the stomach and small intestine without being absorbed into the bloodstream. J.A. 9054. And it must be administered throughout the entire length of the colon so that the mesalamine contacts all affected tissues. J.A. 9054. Given these requirements, the oral composition must contain a high percentage, by weight, of mesalamine. '720 patent col. 3 ll. 52-56.
The '720 patent teaches an inner lipophilic matrix and an outer hydrophilic matrix to address the limitations of the prior
art systems. According to the '720 patent, the combination of a lipophilic and hydrophilic matrix in an inner-outer matrix system, respectively, is advantageous because the inner-outer matrix properties cause the mesalamine to be released in a sustained and uniform manner. '720 patent col. 3 ll. 57-59 (" [T]he compositions of the invention provide a release profile of [mesalamine] more homogenous than the traditional systems." ); see also id. at col. 3 l. 60-col. 4 l. 5. The '720 patent also teaches the " advantageous characteristic" of a composition with up to 95% active ingredient by weight. Id. at col. 3 ll. 52-56.
Shire asserts independent claim 1 and dependent claim 3. Claim 1 recites:
1. Controlled-release oral pharmaceutical compositions containing as an active ingredient [mesalamine], 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 triglycerid[e]s, waxes, ceramides, and cholesterol derivatives with melting points below 90° C., and wherein the active ingredient is dispersed both in said 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, hydroxyalkyl celluloses, carboxyalkyl celluloses, polysaccharides, dextrins, pectins, starches and derivatives, alginic acid, and natural or synthetic gums;
c) optionally other excipients;
wherein the active ingredient is present in an amount of 80 to 95% by weight of the total composition, and wherein the active ingredient is dispersed both in the ...