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United States Court of Appeals for the Federal Circuit
May 16, 2016, Decided
[*1358] [***1202] Moore, Circuit Judge.
This case arises under the Hatch—Waxman Act,1 and involves Glenmark Pharmaceuticals Ltd. and Glenmark Pharmaceuticals Inc., USA's (collectively, "Glenmark")2 proposed generic version of Finacea® Gel, a topical medication for various skin disorders. Glenmark appeals the United States District Court for the District of Delaware's final judgment entered in favor of Intendis GmbH, Intraserv GmbH & Co. KG, and Bayer HealthCare Pharmaceuticals Inc. (collectively, "Appellees"). For the reasons set forth below, we affirm.
Appellee Bayer HealthCare Pharmaceuticals Inc. holds approved New Drug Application ("NDA") No. 21470 for Finacea® Gel, which contains azelaic acid as the therapeutically active ingredient in a concentration of 15% by weight and is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Finacea® Gel's inactive ingredients, known as excipients, include triglycerides and lecithin. Finacea® Gel is manufactured in the form of a "hydrogel," which the district court construed to mean "a semisolid dosage form that contains water and a gelling agent to form a gel, which may contain dispersed particles and/or insoluble liquids." Intendis GmbH v. Glenmark Pharm. Ltd., 117 F. Supp. 3d 549, 567-68 (D. Del. 2015).
The Food and Drug Administration's ("FDA") Approved Drug Products with Therapeutic Equivalence Evaluation, commonly known as the Orange Book, lists U.S. Patent No. 6,534,070 ("the '070 patent") as covering Finacea® Gel. The '070 patent, entitled "Composition with Azelaic Acid," is assigned [**3] to Appellee Intraserv GmbH & Co. and exclusively licensed to Appellee Intendis GmbH. The patent issued in March 2003 and claims priority to a provisional application filed on February 12, 1998. Sole independent claim 1 of the '070 patent recites:
1. A composition that comprises:
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
822 F.3d 1355 *; 2016 U.S. App. LEXIS 8907 **; 119 U.S.P.Q.2D (BNA) 1200 ***
INTENDIS GMBH, INTRASERV GMBH & CO. KG, BAYER HEALTHCARE PHARMACEUTICALS INC., Plaintiffs-Appellees v. GLENMARK PHARMACEUTICALS INC., USA, GLENMARK PHARMACEUTICALS LTD., Defendants-Appellants
Prior History: [**1] Appeal from the United States District Court for the District of Delaware in No. 1:13-cv-00421-SLR, Judge Sue L. Robinson.
Intendis GmbH v. Glenmark Pharms. Ltd., 117 F. Supp. 3d 549, 2015 U.S. Dist. LEXIS 97403 (D. Del., 2015)
district court, lecithin, excipients, penetration, enhancers, infringement, triglyceride, prior art, doctrine of equivalents, acid, hypothetical, argues, estoppel, azelaic, patent, composition, myristate, isopropyl, skilled, generic, Gel, clear error, artisan, independent claim, concentration, asserted claim, function-way-result, formulations, ingredient, combine
Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Patent Law, Jurisdiction & Review, Standards of Review, Clearly Erroneous Review, Doctrine of Equivalents, Elements, Equivalence, Infringement Actions, Fact & Law Issues, Ordinary Skill, Claim Interpretation, Aids & Extrinsic Evidence, Equivalence Limits, Prosecution History Estoppel, Abandonment & Amendment, Prosecution Related Arguments & Remarks, De Novo Review