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IN RE ROSUVASTATIN CALCIUM PATENT LITIGATION

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

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.

United States Court of Appeals, Federal Circuit.

Decided: December 14, 2012.

Attorney(s) appearing for the Case

CHARLES E. LIPSEY , Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, of Reston, Virginia, argued for plaintiff-appellee. With him on the brief were KENNETH M. FRANKEL , and YORK M. FAULKNER . Of counsel on the brief were FORD F. FARABOW, JR. , and HOWARD W. LEVINE , of Washington, DC, MARY K. FERGUSON , of Cambridge, Massachuettes, JOHN D. LIVINGSTONE , of Atlanta, Georgia, MARY W. BOURKE , Connolly Bove Lodge & Hutz, LLP, of Wilmington, Delaware, HENRY J. RENK , Fitzpatrick, Cella, Harper & Scinto, of New York, New York, THOMAS STEVENS and JUDY YUN , AstraZeneca Pharmaceuticals, LP, of Wilmington, Delaware.

ROBERT B. BREISBLATT , Katten Muchin Rosenman, LLP, of Chicago, Illinois, argued for defendant-appellant. With him on the brief were JEREMY C. DANIEL and CHARLES B. PARADIS .

JEFFREY S. WARD , Merchant & Gould, P.C., of Madison, Wisconsin, argued for defendant-appellant. With him on the brief were THOMAS P. HENEGHAN , EDWARD J. PARDON , and SHANE A. BRUNNER .

STEVEN A. MADDOX , Knobbe, Martens, Olson & Bear, LLP, of Washington, DC, argued for defendant-appellant. With him on the brief were PAYSON LEMEILLEUR and JARED BUNKER , Knobbe, Martens, Olson & Bear, LLP, of Irvine, California.

Opinion of the court filed by NEWMAN. Concurring opinion filed by PLAGER. Dissenting opinion filed by MAYER.

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...

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