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TEVA PHARMACEUTICALS, USA, INC. v. LEAVITT

No. 08-5141.

548 F.3d 103 (2008)

TEVA PHARMACEUTICALS, USA, INC., Appellee v. Michael O. LEAVITT, In His Official Capacity as Secretary of Health and Human Services, et al., Appellants.

United States Court of Appeals, District of Columbia Circuit.

Decided November 7, 2008.

Attorney(s) appearing for the Case

Gerald F. Masoudi, Associate General Counsel, U.S. Department of Health and Human Services, argued the cause for appellants. With him on the briefs were Gregory G. Katsas, Acting Assistant Attorney General, U.S. Department of Justice, C. Frederick Beckner III, Deputy Assistant Attorney General, Eugene M. Thirolf, Director, Drake Cutini, Attorney, and Eric M. Blumberg, Deputy Chief Counsel, U.S. Department of Health and Human Services.

Jay P. Lefkowitz argued the cause for appellee. With him on the brief were Michael D. Shumsky and Gregory L. Skidmore.

Opinion concurring in the judgment filed by Senior Circuit Judge WILLIAMS.

BROWN, Circuit Judge:

The Hatch-Waxman Amendments help to expedite the marketing of generic drugs. Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, § 101, 98 Stat. 1585, 1585 (1984). Getting a new "branded" drug to market is a time-consuming process. The manufacturer must file a New Drug Application (NDA) with the Food and Drug Administration (FDA), showing the new drug is safe and effective and identifying the number and expiration...

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