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APOTEX, INC. v. FOOD & DRUG ADMIN.

No. 04-5211.

393 F.3d 210 (2004)

APOTEX, INC., Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided December 21, 2004.

Attorney(s) appearing for the Case

William A. Rakoczy argued the cause for appellant. With him on the briefs were Christine J. Siwik, Matthew O. Brady, Amy D. Brody, Lara Monroe-Sampson, and Arthur Y. Tsien.

Charles J. Raubicheck argued the cause for appellee Purepac Pharmaceutical Company. With him on the brief was William B. Schultz. Ronald H. Weich entered an appearance.

Howard S. Scher, Attorney, U.S. Department of Justice, argued the cause for federal appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Kenneth L. Wainstein, U.S. Attorney, Douglas N. Letter, Attorney, Alex M. Azar, II, General Counsel, U.S. Department of Health & Human Services, Daniel E. Troy, Chief Counsel, and Karen E. Schifter, Counsel.

Before: EDWARDS, SENTELLE, and RANDOLPH, Circuit Judges.

HARRY T. EDWARDS, Circuit Judge.

Since December 2002, the District Court has issued three decisions in connection with disputes between Apotex, Inc. ("Apotex") and Purepac Pharmaceutical Co. ("Purepac") over the marketing of a generic version of the drug gabapentin. The Food and Drug Administration ("FDA" or "agency") has approved gabapentin, sold by Pfizer, Inc. ("Pfizer") under the brand name Neurontin, for the treatment of epilepsy. The first two decisions,

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