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WYETH HOLDINGS CORP. v. SEBELIUS

No. 2009-1368.

603 F.3d 1291 (2010)

WYETH HOLDINGS CORPORATION and Wyeth (now known as Wyeth LLC), Plaintiffs-Appellants, v. Kathleen SEBELIUS, Secretary of Health and Human Services, Department of Health and Human Services, Dr. Margaret Hamburg, Commissioner of Food and Drugs, United States Food and Drug Administration, David Kappos, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, and United States Patent and Trademark Office, Defendants-Appellees.

United States Court of Appeals, Federal Circuit.

May 3, 2010.

Attorney(s) appearing for the Case

Randolph D. Moss, Wilmer Cutler Pickering Hale and Dorr LLP, of Washington, DC, argued for plaintiffs-appellants. With him on the brief were Brian M. Boynton and Brian H. Fletcher.

Howard S. Scher, Attorney, Appellate Staff, Civil Division, United States Department of Justice, of Washington, DC, argued for defendants-appellees. With him on the brief were Tony West, Assistant Attorney General, Channing D. Phillips, Acting United States Attorney, and Scott R. McIntosh, Attorney. Of counsel on the brief were David S. Cade, Acting General Counsel, Michael M. Landa, Acting Associate General Counsel, Eric M. Blumberg, Deputy Chief Counsel, and James R. Johnson, Associate Chief Counsel, Office of the General Counsel, Food and Drug Division, United States Department of Health and Human Services, of Rockville, MD. Of counsel was Drake S. Cutini, Office of Consumer Litigation, United States Department of Justice, of Washington, DC.

Before BRYSON and MOORE, Circuit Judges, and FOLSOM, Chief District Judge.

MOORE, Circuit Judge.

Wyeth Holdings Corporation and Wyeth LLC (Wyeth) appeal the judgment, pursuant to summary judgment, of the United States District Court for the District of Columbia rejecting Wyeth's challenge to the United States Food and Drug Administration's (FDA's) determination of the date on which the approval phase of its phased regulatory review process begins for purposes of calculating patent term extensions. For the reasons discussed below, we affirm...

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