APOTEX, INC. v. THOMPSON

No. 02-1295.

347 F.3d 1335 (2003)

APOTEX, INC., Plaintiff-Appellant, v. Tommy G. THOMPSON, Secretary of Health and Human Services, U.S. Food and Drug Administration, and Lester M. Crawford, Deputy Commissioner, U.S. Food and Drug Administration, Defendants-Appellees, and Smithkline Beecham Corporation, Defendant-Appellee.

United States Court of Appeals, Federal Circuit.

Decided October 27, 2003.


Attorney(s) appearing for the Case

Hugh L. Moore, Lord, Bissell & Brook, of Chicago, Illinois, argued for plaintiff-appellant. With him on the brief were Terrence P. Canade and Hugh S. Balsam. Of counsel on the brief was Arthur Y. Tsien, Olsson, Frank and Weeda, P.C., of Washington, DC.

Daniel E. Troy, Chief Counsel, Office of the Chief Counsel, Food and Drug Administration, of Rockville, Maryland, argued for defendants-appellees Tommy G. Thompson, Secretary of Health and Human Services, et al. With him on the brief were Eric M. Blumberg, Deputy Chief Counsel for Litigation; and Karen E. Schifter, Associate Chief Counsel, Food and Drug Administration, and Alex M. Azar II, General Counsel, Department of Health and Human Services, of Washington, DC. On the brief for defendants-appellees were Douglas N. Letter and Howard S. Scher, Attorneys, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC.

E. Edward Bruce, Covington & Burling, of Washington, DC, argued for defendant-appellee Smithkline Beecham Corporation. On the brief were Bruce N. Kuhlik, Christopher N. Sipes, and Elizabeth S. Weiswasser. Of counsel was Stephen T. Kaminski.

Before NEWMAN, Circuit Judge, PLAGER, Senior Circuit Judge, and BRYSON, Circuit Judge.


Opinion of the Court filed by Circuit Judge BRYSON. Concurring opinion filed by Senior Circuit Judge PLAGER. Dissenting opinion filed by Circuit Judge PAULINE NEWMAN.

BRYSON, Circuit Judge.

A company that seeks to market a pharmaceutical drug in the United States must first obtain approval from the Food and Drug Administration ("FDA"). Ordinarily, a pharmaceutical company initiates that process by filing a New Drug Application ("NDA"), demonstrating through...

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