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TEVA PHARMACEUTICALS v. FOOD & DRUG ADMIN

No. 05-5401, 05-5460.

441 F.3d 1 (2006)

TEVA PHARMACEUTICALS USA, INC., Appellee v. FOOD & DRUG ADMINISTRATION, et al., Appellants Apotex Inc., Appellant.

United States Court of Appeals, District of Columbia Circuit.

Decided March 16, 2006.

Attorney(s) appearing for the Case

Jeffrey S. Bucholtz, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for federal appellants. With him on the briefs were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, and Andrew E. Clark, Attorney.

William A. Rakoczy argued the cause for appellant Apotex Inc. With him on the briefs were Christine J. Siwik, Lara E. Monroe-Sampson, and Arthur Y. Tsien.

Jay P. Lefkowitz argued the cause for appellee. With him on the brief was Steven A. Engel, John C. O'Quinn, and Michael D. Shumsky.

Before: RANDOLPH and TATEL, Circuit Judges, and WILLIAMS, Senior Circuit Judge.

Opinion for the Court filed by Circuit Judge RANDOLPH.

RANDOLPH, Circuit Judge:

The Federal Food, Drug, and Cosmetic Act grants a 180-day exclusive marketing period to the first generic drug manufacturer to file an Abbreviated New Drug Application ("application") that contains a challenge to the patents protecting a brand name drug. This exclusivity period begins to run either upon "notice [to the FDA] of the first...

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