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TEVA PHARMACEUTICALS, USA, INC. v. U.S. F.D.A.

Nos. 99-5022 and 99-5027.

182 F.3d 1003 (1999)

TEVA PHARMACEUTICALS, USA, INC., Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided July 20, 1999.

Attorney(s) appearing for the Case

Geoffrey M. Levitt and James N. Czaban argued the cause for appellant. With them on the briefs was David M. Malone.

Robert A. Dormer, James R. Phelps and Douglas B. Farquhar were on the brief for appellant Purepac Pharmaceutical Company.

Andrew E. Clark, Attorney, U.S. Department of Justice, argued the cause for the federal appellees. With him on the brief were David W. Ogden, Acting Assistant Attorney General, Eugene Thirolf, Jr., Director, Office of Consumer Litigation, and Drake S. Cutini, Attorney.

James D. Miller argued the cause for intervenors-appellees TorPharm, a Division of Apotex, Inc., et al. With him on the brief were Eugene M. Pfeifer, Peter M. Todaro, Donald O. Beers and David E. Korn.

Before: EDWARDS, Chief Judge, ROGERS, Circuit Judge and BUCKLEY, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge ROGERS.

ROGERS, Circuit Judge:

Teva Pharmaceuticals and Purepac Pharmaceutical Company appeal the denial of injunctive relief requiring the Food and Drug Administration ("FDA") to recognize the dismissal of a declaratory judgment complaint for patent infringement as a "court decision" under the Abbreviated New Drug Application ("ANDA") statute. See 21 U.S.C. § 355(j)(5)(B)(iv)(II) (Supp. III 1997). Appellants...

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