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In re Rosuvastatin Calcium Patent Litig. v. Aurobindo Pharma Ltd.

United States Court of Appeals for the Federal Circuit

December 14, 2012, Decided

2010-1460, 2010-1461, 2010-1462, 2010-1463, 2010-1464, 2010-1465, 2010-1466, 2010-1467, 2010-1468, 2010-1469, 2010-1470, 2010-1471, 2010-1472, 2010-1473

Opinion

 [***1438]   [*514]  Newman, Circuit Judge.

This ] patent litigation arises under the Hatch-Waxman Act, 21 U.S.C. §355, whereby producers of generic pharmaceutical products are authorized to challenge the patent status of a federally registered and approved drug product, before the generic producer has obtained approval to sell its counterpart of the approved product. The generic litigant who succeeds in eliminating the drug patent is granted a 180-day period of exclusivity against other potential providers of the generic product. 21 U.S.C. §355(j)(5)(B)(iv).

The drug product here at issue is the "statin" having the brand name Crestor®, which is federally approved for use in control of cholesterol and for treatment of atherosclerosis. In suit is United States Reissue Patent No. 37,314 ("the '314 patent"), which  [**3] is a reissue of United States  [*515]  Patent No. 5,260,440 ("the '440 patent"). The patentee is Shionogi Seiyaku Kabushiki Kaisha ("Shionogi") and the exclusive licensee is Astrazeneca UK and its United States subsidiary IPR Pharmaceuticals Inc. (collectively "Plaintiffs").

The active ingredient of Crestor® is the calcium salt of a chemical compound whose common name is [***1439]  rosuvastatin, of the following structural formula:

rosuvastatin

Rosuvastatin is one of several statin products that lower cholesterol production in the liver by inhibiting the enzyme HMG-CoA reductase. Scientists working at the Shionogi laboratory in Japan were conducting research in search of a statin with reduced side effects as compared with the statin products that were then known. In the course of this research, in 1991 they discovered rosuvastatin and its beneficial properties. Patents were obtained in Japan and other countries, including the '314 patent in the United States.

Federal approval for sale and use in the United States was granted on August 12, 2003, after over two decades of development. The product was highly successful, due to its superior efficacy in lowering low-density (LDL) cholesterol and elevating high-density  [**4] (HDL) cholesterol, and its reduced side effects, as compared with other commercial statins. See Peter H. Jones et al., Comparison of the Efficacy and Safety of Rosuvastatin Versus Atorvastatin, Simvastatin, and Pravastatin Across Doses (STELLAR Trial), 92 Am. J. Cardiology 152 (2003).

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703 F.3d 511 *; 2012 U.S. App. LEXIS 25694 **; 105 U.S.P.Q.2D (BNA) 1437 ***

IN RE ROSUVASTATIN CALCIUM PATENT LITIGATION; ASTRAZENECA UK LIMITED, IPR PHARMACEUTICALS INC., AND SHIONOGI SEIYAKU KABUSHIKI KAISHA, Plaintiffs-Appellees, v. AUROBINDO PHARMA LIMITED, Defendant-Appellant, AND MYLAN PHARMACEUTICALS INC., Defendant-Appellant, AND APOTEX CORP., Defendant-Appellant, AND COBALT PHARMACEUTICALS INC. AND COBALT LABORATORIES INC., Defendants-Appellants, AND SUN PHARMACEUTICAL INDUSTRIES, LTD., Defendant-Appellant, AND TEVA PHARMACEUTICALS USA, INC., Defendant-Appellant, AND PAR PHARMACEUTICAL, INC., Defendant-Appellant, AND SANDOZ, INC., Defendant.

Prior History:  [**1] Appeal from the United States District Court for the District of Delaware in case nos. 08-MD-1949, 07-CV-0810, 07-CV-0805, 07-CV-0809, 07-CV-0811, 07-CV-0806, 08-CV-0426, and 07-CV-0808, Judge Joseph J. Farnan, Jr.

AstraZeneca Pharms. LP v. Mylan Pharms. Inc. (In re Rosuvastatin Calcium Patent Litigation), 719 F. Supp. 2d 388, 2010 U.S. Dist. LEXIS 64475 (D. Del., 2010)

CORE TERMS

patent, reissue, compound, district court, rosuvastatin, patentee, deceptive, prior art, overlap, infringement, statin, invalid, deliberate, inequitable conduct, references, inadvertence, manufacture, invention, generic, argues, submits, act of infringement, patent application, Pharmaceuticals, disclosure, disclose, intent to deceive, original patent, original claim, filing date

Business & Corporate Compliance, Governments, Agriculture & Food, Federal Food, Drug & Cosmetic Act, Patent Law, Infringement Actions, Infringing Acts, General Overview, Nonobviousness, Elements & Tests, Defenses, Inequitable Conduct, Burdens of Proof, US Patent & Trademark Office Proceedings, Reissue Proceedings, Requirements, Elements, Best Mode, Required Disclosure, Adequate Disclosure