SHIRE DEVELOPMENT, LLC, SHIRE PHARMACEUTICAL DEVELOPMENT, INC., COSMO TECHNOLOGIES LIMITED, AND GIULIANI INTERNATIONAL LIMITED, Plaintiffs-Appellees,
WATSON PHARMACEUTICALS, INC. (now known as Actavis, Inc.), WATSON LABORATORIES, INC. FLORIDA, WATSON PHARMA, INC. (now known as Actavis Pharma, Inc.), AND WATSON LABORATORIES, INC., Defendants-Appellants
Petition for certiorari filed at, 08/18/2014
Appeal from the United States District Court for the Southern District of Florida in No. 12-CV-60862, Judge Donald M. Middlebrooks.
EDGAR H. HAUG, Frommer Lawrence & Haug, LLP, of New York, New York, argued for plaintiffs-appellees. With him on the brief were JASON A. LIEF, ANDREW S. WASSON, NICHOLAS F. GIOVE, ELIZABETH MURPHY, and JONATHAN A. HERSTOFF.
STEVEN A. MADDOX, Knobbe, Martens, Olson & Bear, LLP, of Washington, DC, argued for defendants-appellants. With him on the brief were JONATHAN E. BACHAND and NEIL M. MCCARTHY. Of counsel was KRISTIN MARIE COOKLIN, Crowell & Moring, LLP, of Washington, DC.
Before RADER, Chief Judge, PROST and HUGHES, Circuit Judges.
Hughes, Circuit Judge .
The plaintiffs-appellees (collectively, Shire) own 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 the defendants-appellants (collectively, 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. We conclude that the district court's constructions of " inner lipophilic matrix" and " outer hydrophilic matrix" impermissibly broaden the ordinary meaning of the terms. Accordingly, we reverse the district court's claim constructions of " inner lipophilic matrix" and " outer hydrophilic matrix," and subsequent finding of infringement, and remand for further proceedings consistent with this opinion.
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 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. '720 patent 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 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 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 lipophilic matrix and in the hydrophilic matrix.
'720 patent col. 6 ll. 7-30. Claim 3 depends from claim 1 and requires that the composition be in the form of tablets, capsules, or minitablets. '720 patent col. 6 ll. 35-36.
The '720 patent teaches a three-step process to arrive at the claimed composition. '720 patent col. 2 ll. 48-59. First, one or more low melting, lipophilic excipients are mixed with mesalamine during heating. '720 patent col. 2 ll. 50-53. Second, the mixture is cooled to form the lipophilic matrix and then reduced in size into " matrix granules containing the active ingredient." '720 patent col. 2 ll. 54-56. Third, the lipophilic matrix granules are mixed together with hydrophilic excipients and compressed to form tablets. '720 patent col. 2 ll. 50-53, col. 3 ll. 40-45.
During prosecution of the '720 patent, the examiner initially rejected the applicants' claims as obvious in view of GB 2 245 492 A (Franco); obvious and ...