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TEVA PHARMACEUTICAL INDUSTRIES LTD. v. CRAWFORD

No. 05-5004.

410 F.3d 51 (2005)

TEVA PHARMACEUTICAL INDUSTRIES LTD. and TEVA PHARMACEUTICALS, USA, INC., Appellants v. Lester M. CRAWFORD, Jr., Acting Commissioner of Food and Drugs, et al., Appellees

United States Court of Appeals, District of Columbia Circuit.

Decided June 3, 2005.

Attorney(s) appearing for the Case

William H. Rooney argued the cause for appellants. With him on the briefs were Theodore C. Whitehouse and James N. Czaban.

William A. Rakoczy, Christine J. Siwik, Amy D. Brody, and Lara E. Monroe-Sampson were on the brief for amicus curiae Mylan Pharmaceuticals, Inc. in support of appellants.

Jeffrey S. Bucholtz, Deputy Assistant Attorney General, U.S. Department of Justice, argued the cause for federal appellees. With him on the brief were Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, Andrew E. Clark, Attorney, Alex M. Azar, II, General Counsel, Food & Drug Administration, and Eric M. Blumberg, Deputy Chief Counsel.

Bert W. Rein argued the cause for appellees Pfizer Inc., et al. With him on the brief were Karyn K. Ablin and Jeffrey B. Chasnow.

Before: GINSBURG, Chief Judge, and SENTELLE and ROGERS, Circuit Judges.

GINSBURG, Chief Judge.

Teva Pharmaceutical Industries has sued to overturn the Food and Drug Administration's denial of its "citizen petition" requesting that the agency prohibit Pfizer, Inc., the holder of the approved New Drug Application (NDA) for gabapentin, from marketing that drug in "generic" form during the 180-day exclusivity period provided by the Drug Price Competition and Patent Term Restoration Act, also known...

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