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AstraZeneca Pharms. LP v. Apotex Corp.

United States Court of Appeals for the Federal Circuit

February 9, 2012, Decided

2011-1182, -1183, -1184, -1185, -1186, -1187, -1188, -1189, -1190

Opinion

 [***1676]  [*1372]   Lourie, Circuit Judge.

AstraZeneca Pharmaceuticals LP, AstraZeneca AB, IPR Pharmaceuticals, Inc.,  [**3] and The Brigham and Women's Hospital, Inc. (collectively, "AstraZeneca") appeal from the consolidated final orders of the United States District Court for the District of Delaware dismissing their  [*1373]  § 271(e)(2) patent infringement claims against Apotex Corp., Aurobindo Pharma Ltd., Cobalt Pharmaceuticals Inc., Cobalt Laboratories Inc., Glenmark Generics Inc. USA, Mylan Pharmaceuticals Inc., Par Pharmaceuticals Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., Torrent Pharma Inc., and Torrent Pharmaceuticals Ltd. (collectively, "Appellees"). AstraZeneca Pharms. LP v. Apotex Corp., Nos. 10-338 to -346 and 10-584, 2010 U.S. Dist. LEXIS 132727, 2010 WL 5376310 (D. Del. Dec. 22, 2010). For the reasons indicated below, we affirm. [***1677]  

Background

The dispute before us involves patented methods for using the cholesterol-lowering drug rosuvastatin calcium. Rosuvastatin calcium is one member of a widely prescribed class of drugs known as statins, which serve to reduce circulating cholesterol by competitively inhibiting 3-hydroxy-3-methylglutaryl-CoA reductase, or HMG-CoA reductase, a key enzyme in the cholesterol biosynthesis pathway. AstraZeneca markets rosuvastatin calcium under  [**4] the brand name CRESTOR® and holds the rights to three related patents relevant to this appeal. U.S. Patent RE37,314 ("the '314 patent") claims rosuvastatin compounds and pharmaceutical compositions containing such compounds. U.S. Patent 6,858,618 ("the '618 patent") claims methods of using rosuvastatin compounds to treat heterozygous familial hypercholesterolemia ("HeFH"), a genetic condition characterized by impaired cholesterol metabolism and clinically elevated blood cholesterol, and U.S. Patent 7,030,152 ("the '152 patent") claims methods of using rosuvastatin compounds to lower the cardiovascular disease risk for individuals who have normal cholesterol levels but demonstrate elevated circulating C-reactive protein ("CRP"), another risk factor associated with various cardiovascular disorders. The '314 composition patent expires in 2016, while the '618 and '152 method of use patents expire in 2021 and 2018, respectively.1

AstraZeneca filed a New  [**5] Drug Application ("NDA") to market rosuvastatin calcium and obtained approval from the U.S. Food and Drug Administration ("FDA") on August 12, 2003. As required by the Drug Price Competition and Patent Term Restoration Act of 1984 (popularly known as the Hatch-Waxman Act, hereinafter "the Act"), AstraZeneca notified the FDA of all patents that it believed could be infringed by the unlicensed manufacture, use, or sale of rosuvastatin calcium to be published in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (known as "the Orange Book"). See 21 U.S.C. § 355(b)(1). Among those patents, AstraZeneca listed the '314, '618, and '152 patents. The approved NDA and AstraZeneca's corresponding CRESTOR® labeling cover several indications for using rosuvastatin calcium, including treatment of HeFH in pediatric patients and preventative use in high-risk patients with elevated CRP. J.A. 152. While these indications may fall under AstraZeneca's method patents, the FDA also approved rosuvastatin calcium for treating homozygous familial hypercholesterolemia ("HoFH") and hypertriglyceridemia—uses not claimed by either of the '618 or '152 patents. Thus, the FDA approved rosuvastatin  [**6] calcium for a number of different treatment indications, some of which may be protected by AstraZeneca's '618 and '152 patents, i.e., the HeFH and elevated CRP indications, as well as others not subject to any such  [*1374]  patent rights, e.g., treatment of HoFH and hypertriglyceridemia.

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669 F.3d 1370 *; 2012 U.S. App. LEXIS 2512 **; 101 U.S.P.Q.2D (BNA) 1675 ***; 2012 WL 400306

ASTRAZENECA PHARMACEUTICALS LP, ASTRAZENECA AB, IPR PHARMACEUTICALS INC., AND THE BRIGHAM AND WOMEN'S HOSPITAL, INC., Plaintiffs-Appellants, v. APOTEX CORP., Defendant-Appellee, and AUROBINDO PHARMA LIMITED, Defendant-Appellee, and COBALT PHARMACEUTICALS INC. AND COBALT LABORATORIES INC., Defendants-Appellees, and GLENMARK GENERICS INC. USA, Defendant-Appellee, and MYLAN PHARMACEUTICALS INC., Defendant-Appellee, and PAR PHARMACEUTICALS, INC., Defendant-Appellee, and SUN PHARMACEUTICAL INDUSTRIES, LTD., Defendant-Appellee, and TEVA PHARMACEUTICALS USA, INC., Defendant-Appellee, and TORRENT PHARMA INC. AND TORRENT PHARMACEUTICALS LTD., Defendants.

Prior History:  [**1] Appeals from the United States District Court for the District of Delaware in Case Nos. 10-CV-0338, 10-CV-0339, 10-CV-0340, 10-CV-0341, 10-CV-0342, 10-CV-0343, 10-CV-0345, 10-CV-0346, and 10-CV-0584, Judge Robert B. Kugler.

Astrazeneca Pharms. LP v. Apotex Corp., 2010 U.S. Dist. LEXIS 132727 (D. Del., Dec. 15, 2010)

Disposition: AFFIRMED.

CORE TERMS

patent, infringement, rosuvastatin, calcium, district court, indications, generic, labeling, Pharmaceuticals, certification, seek approval, manufacturers, unpatented, act of infringement, infringement claim, composition, compounds, patients, expire, carve, subject matter jurisdiction, patent infringement, cholesterol, elevated, Tablets, filings, argues

Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Patent Law, Utility Patents, Product Patents, Compositions of Matter, Civil Procedure, Appeals, Standards of Review, Clearly Erroneous Review, Jurisdiction, Subject Matter Jurisdiction, General Overview, De Novo Review, Governments, Legislation, Interpretation, Questions of Fact & Law, Jurisdiction & Review, Infringement Actions, Infringing Acts, Justiciability, Ripeness, Constitutional Law, The Judiciary, Case or Controversy, Ripeness