GLAXOSMITHKLINE LLC (formerly known as SmithKline Beecham Corporation), Plaintiff-Appellee,
BANNER PHARMACAPS, INC. AND IMPAX LABORATORIES, INC., Defendants-Appellants, AND ROXANE LABORATORIES, INC., Defendant-Appellant, AND MYLAN INC. AND MYLAN PHARMACEUTICALS INC., Defendants-Appellants, AND WATSON LABORATORIES, INC. FLORIDA, Defendant-Appellant
Appeals from the United States District Court for the District of Delaware in Nos. 11-CV-0046, 11-CV-0542 and 11-CV-0789, Judge Richard G. Andrews.
WILLIAM F. LEE, Wilmer Cutler Pickering Hale and Dorr, LLP, of Boston, Massachusetts, argued for plaintiff-appellee. With him on the brief were LISA J. PIROZZOLO and SARAH R. FRAZIER, of Boston, Massachusetts; WILLIAM G. MCELWAIN, THOMAS G. SAUNDERS and MATTHEW GUARNIERI, of Washington, DC; and CHRISTOPHER R. NOYES, of New York, New York.
DEANNE E. MAYNARD, Morrison & Foerster, LLP, of Washington, DC, argued for all defendants-appellants. With her on the brief for defendants-appellants Banner Pharmacaps, Inc., et al., were MARC A. HEARRON, of Washington, DC and PARISA JORJANI, of San Francisco, California. Of counsel on the brief were C. KYLE MUSGROVE and MICHAEL M. SHEN, Haynes and Boone, LLP, of Washington, DC. On the brief for Roxane Laboratories, Inc. were KENNETH G. SCHULER and MARC N. ZUBICK, Latham & Watkins LLP, of Chicago, Illinois; and DARRYLL H. STEENSMA, of San Diego, California. On the brief for Watson Laboratories, Inc. - Florida were GARY E. HOOD and MARK T. DEMING, Polsinelli, PC, of Chicago, Illinois. On the brief for Mylan Inc., et al. were JAMES H. WALLACE, JR., MARK A. PACELLA, and LUCY M. STARK, Wiley Rein, LLP, of Washington, DC.
Before O'MALLEY, WALLACH, and TARANTO, Circuit Judges.
Taranto, Circuit Judge.
Plaintiff GlaxoSmithKline LLC (" GSK" ) sued Banner Pharmacaps, Inc., Impax Laboratories, Inc., Roxane Laboratories, Inc., Mylan Inc., Mylan Pharmaceuticals, Inc., and Watson Laboratories, Inc.--Florida (collectively, " Defendants" ). Invoking 35 U.S.C. § 271(e)(2), GSK alleged that drug products containing the molecule dutasteride that Defendants propose to market fall within claims of U.S. Patent No. 5,565,467, which covers dutasteride and its pharmaceutically acceptable solvates. All Defendants stipulated to infringement, which is no longer an issue, but alleged that the asserted claims were invalid for anticipation, lack of utility, lack of enablement, and inadequacy of the written description. After a three-day bench trial, the district court issued an opinion concluding that Defendants did not prove the asserted claims invalid. GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 11-CV-046, 2013 WL 4082232 (D. Del. Aug. 9, 2013).
Defendants appeal the rejection of their written-description challenge. Their appeal presents only one contention--that " solvate" is not adequately described, whether construed as Defendants urge or as the district court construed it. We affirm, without resolving the claim-construction dispute.
This case involves claims to the chemical compound dutasteride and its pharmaceutically acceptable solvates. Claim 1 of the '467 patent, the only independent claim,
reads, " 17a-N-(2,5-bis(Trifluoromethyl))phenylcarbamoyl-4-aza-5a-androst-1-en-3-one or a pharmaceutically acceptable solvate thereof." '467 patent, col. 16, lines 4-6. The parties agree that dutasteride is the molecule identified before " or a pharmaceutically acceptable solvate thereof." The other asserted claims all recite " [a] pharmaceutical formulation comprising" the " compound of claim 1," subject to further restrictions having no effect on the issue presented here. See id. at col. 16, lines 7-20 (dependent claims 2 through 5).
Dutasteride " is useful in the treatment of androgen responsive diseases." '467 patent, col. 10, lines 19-20. Androgens are a class of hormones--with testosterone " the major circulating androgen" --implicated in a number of diseases, including " benign prostatic hyperplasia, prostate cancer, acne, male pattern baldness and hirsutism." Id. at col. 1, lines 18-19, 55-60. In some target tissues, including prostate and skin tissue, testosterone produces certain effects by first being converted to dihy-drotestosterone. See id. at col. 1, lines 15-25. Dutasteride inhibits the enzymes that catalyze the conversion and thus mitigates some of testosterone's physiological effects, which is sometimes medically desirable. See id.
The asserted claims cover not only dutasteride, but also any " pharmaceutically acceptable solvate thereof." A " solvate," by definition, is something that originates in a " solution," which is a mixture of two substances: a " solute" dissolved in a " solvent." Salt water is a solution, in which salt is the solute and water the solvent. A solvate is a molecule (a) consisting of a complex made up of solute molecules and solvent molecules (b) resulting from the solution. The parties agree on that much, and also on the proposition that, at least frequently, a solvate complex is " crystalline," a purely structural description referring to the regular, periodic arrangement of the constituent molecules or atoms. The parties disagree about ...