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TEVA PHARMACEUTICALS USA, INC. v. SEBELIUS

Civil Action No. 09-1111 (RMC).

638 F.Supp.2d 42 (2009)

TEVA PHARMACEUTICALS USA, INC., Plaintiff, v. Kathleen SEBELIUS, Secretary of Health and Human Services, et al., Defendants.

United States District Court, District of Columbia.

July 31, 2009.

Attorney(s) appearing for the Case

Gregory L. Skidmore, Jay P. Lefkowitz, Michael D. Shumsky, Kikland & Ellis, LLP, Washington, DC, for Plaintiff.

Drake S. Cutini, Department of Justice Office of Consumer Litigation, Washington, DC, for Defendants.

MEMORANDUM OPINION

ROSEMARY M. COLLYER, District Judge.

Teva Pharmaceuticals USA, Inc. ("Teva"), a manufacturer of generic drugs, seeks a preliminary injunction to invalidate a "Delisting Rule" instituted by the Food and Drug Administration ("FDA"). The FDA contends that there is no such "Delisting Rule." Instead, in informal adjudications regarding other drugs, the FDA has held that a name brand manufacturer's withdrawal of a patent as a basis for its drug...

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