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PUREPAC PHARMACEUTICAL CO. v. THOMPSON

Nos. 02-5410 and 03-5121.

354 F.3d 877 (2004)

PUREPAC PHARMACEUTICAL COMPANY, Appellee, v. Tommy G. THOMPSON, Secretary of Health and Human Services, and Lester M. Crawford Jr., Deputy Commissioner of Food and Drugs, Appellees. Torpharm, Inc. and Apotex, Inc., Appellants.

United States Court of Appeals, District of Columbia Circuit.

Decided January 20, 2004.

Attorney(s) appearing for the Case

William A. Rakoczy argued the cause for appellants. With him on the briefs were Hugh S. Balsam and Arthur Y. Tsien. Hugh L. Moore, Jacqueline H. Eagle, and Matthew O. Brady entered appearances.

Andrew E. Clark, Attorney, U.S. Department of Justice, argued the cause for the federal appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General; Eugene M. Thirolf, Director; Alex M. Azar II, General Counsel, U.S. Department of Health & Human Services; Daniel E. Troy, Chief Counsel; and Karen E. Schifter, Associate Chief Counsel. Christine N. Kohl, Attorney, U.S. Department of Justice; Douglas N. Letter, Litigation Counsel; and Howard S. Scher, Attorney, entered appearances.

Charles J. Raubicheck argued the cause for appellee Purepac Pharmaceutical Company. With him on the brief was Steven M. Amundson. James M. Webster, Mark C. Hansen, and Richard H. Stern entered appearances.

Before: GINSBURG, Chief Judge, and EDWARDS and TATEL, Circuit Judges.

Opinion for the Court filed by Circuit Judge TATEL.

TATEL, Circuit Judge:

To encourage the marketing of low-cost generic drugs, the 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act grant companies that successfully challenge drug patents the right to sell their generic drugs without competition for 180 days. In this case, two companies, each seeking to market a generic drug, competed for the right to exclusivity. The Food and Drug Administration...

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