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NOVARTIS PHARMACEUTICALS CORP. v. LEAVITT

No. 04-5414.

435 F.3d 344 (2006)

NOVARTIS PHARMACEUTICALS CORPORATION, Appellant v. Michael O. LEAVITT, Secretary of Health and Human Services, and Lester M. Crawford, Jr., Acting Commissioner of Food and Drugs, Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided January 27, 2006.

Attorney(s) appearing for the Case

John M. Engel III argued the cause and filed the briefs for appellant.

Drake Cutini, Attorney, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Jr., Director, Alex M. Azar II, General Counsel, U.S. Department of Health and Human Services, Eric M. Blumberg, Deputy Chief Counsel, and Karen E. Schifter, Associate Chief Counsel.

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

STEPHEN F. WILLIAMS, Senior Circuit Judge.

Securing FDA approval for a generic drug is generally a much simpler and faster process than securing approval for a "pioneer" drug. Instead of directly demonstrating the drug's safety and efficacy, see 21 U.S.C. § 355(a), manufacturers of the generic file an abbreviated new drug application ("ANDA") that need show only that the generic is the same as the pioneer drug along certain dimensions. See § 355(j)(2)(A...

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