TEVA PHARMACEUTICALS USA, INC. v. PFIZER, INC.

No. 04-1186.

395 F.3d 1324 (2005)

TEVA PHARMACEUTICALS USA, INC., Plaintiff-Appellant, v. PFIZER, INC., Defendant-Appellee.

United States Court of Appeals, Federal Circuit.

January 21, 2005.


Attorney(s) appearing for the Case

Henry C. Dinger, Goodwin Procter LLP, of Boston, Massachusetts, argued for plaintiff-appellant. Of counsel on the brief was Thomas J. Meloro, Jr., Kenyon & Kenyon, of New York, New York.

Dimitrios T. Drivas, White & Case LLP, of New York, New York, argued for defendant-appellee. With him on the brief were Jeffrey J. Oelke and Adam Gahtan.

William A. Rakoczy, Rakoczy Molino Mazzochi LLP, of Chicago, Illinois, for amicus curiae Generic Pharmaceutical Association. With him on the brief was Lara E. Monroe-Sampson.

Sarah Lenz Lock, AARP Foundation Litigation, of Washington, DC, for amicus curiae AARP. With her on the brief was Bruce Vignery. Of counsel on the brief was Michael Schuster, AARP, of Washington, DC.

William L. Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, LLP, of Westfield, New Jersey, for amicus curiae IVAX Pharmaceuticals, Inc. With him on the brief was Roy H. Wepner.

Lawrence DeMille-Wagman, Attorney, Federal Trade Commission, of Washington, DC, for amicus curiae Federal Trade Commission. With him on the brief were William E. Kovacic, General Counsel; Susan A. Creighton, Director, Bureau of Competition; John F. Daly, Deputy General Counsel for Litigation; and Lore A. Unt, Counsel for Intellectual Property.

Before MAYER, CLEVENGER, and SCHALL, Circuit Judges.


SCHALL, Circuit Judge.

Teva Pharmaceuticals USA, Inc. ("Teva") is a manufacturer of generic pharmaceuticals. In July of 2002, it filed an Abbreviated New Drug Application ("ANDA") pursuant to the provisions of the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act. In its ANDA, Teva sought the approval of the Food and Drug Administration ("FDA") to market its generic version of the drug sertraline hydrochloride. Sertraline hydrochloride is sold under...

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