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MYLAN PHARMACEUTICALS v. U.S. FOOD AND DRUG

No. 05-2160.

454 F.3d 270 (2006)

MYLAN PHARMACEUTICALS, INCORPORATED, Plaintiff-Appellant, v. UNITED STATES FOOD AND DRUG ADMINISTRATION; Lester M. Crawford, Acting Commissioner of the Food and Drug Administration, Defendants-Appellees, and Procter & Gamble Pharmaceuticals, Incorporated; Procter & Gamble Company; Watson Pharmaceuticals, Incorporated; Watson Laboratories, Incorporated, Defendants. Generic Pharmaceutical Association, Amicus Supporting Appellant.

United States Court of Appeals, Fourth Circuit.

Decided: July 5, 2006.

Attorney(s) appearing for the Case

ARGUED: William A. Rakoczy, Rakoczy Molino Mazzochi Siwik, L.L.P., Chicago, Illinois, for Appellant. Jeffrey Stuart Bucholtz, Deputy Assistant Attorney General, United States Department of Justice, Civil Division, Appellate Section, Washington, D.C., for Appellees. ON BRIEF: Christine J. Siwik, Lara E. Monroe-Sampson, Rakoczy Molino Mazzochi Siwik, L.L.P., Chicago, Illinois; Gordon H. Copland, Steptoe & Johnson, P.L.L.C., Clarksburg, West Virginia, for Appellant. Paula M. Stannard, Acting General, Sheldon T. Bradshaw, Associate General, Food and Drug Division, Eric M. Blumberg, Deputy Chief, Litigation, Wendy S. Vicente, Associate Chief, United States Department of Health & Human Services, Office of the General, Rockville, Maryland; Peter D. Keisler, Assistant Attorney General, Eugene M. Thirolf, Director, Office of Consumer Litigation, Andrew E. Clark, United States Department of Justice, Washington, D.C., for Appellees. Arthur Y. Tsien, OLSSON, Frank & Weeda, P.C., Washington, D.C., for Amicus Supporting Appellant.

Before MICHAEL, MOTZ, and SHEDD, Circuit Judges.

Affirmed by published opinion. Judge MICHAEL wrote the opinion, in which Judge MOTZ and Judge SHEDD joined.

OPINION

MICHAEL, Circuit Judge:

The Food and Drug Administration (FDA) approved Mylan Pharmaceuticals, Inc.'s application to sell a generic version of a drug that Procter & Gamble Pharmaceuticals, Inc. sold under the brand name Macrobid. Just as Mylan began selling its generic drug, a third party under license from Procter & Gamble...

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