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ASTRAZENECA PHARMACEUTICALS v. FOOD & DRUG ADMIN.

No. 12-5227.

713 F.3d 1134 (2013)

ASTRAZENECA PHARMACEUTICALS LP, Appellant v. FOOD & DRUG ADMINISTRATION, et al., Appellees.

United States Court of Appeals, District of Columbia Circuit.

Decided April 26, 2013.

Attorney(s) appearing for the Case

Robert A. Long Jr. argued the cause for appellant. With him on the briefs were Timothy C. Hester , Benjamin C. Block , and Matthew J. Berns .

Gerald C. Kell , Senior Trial Counsel, U.S. Department of Justice, argued the cause for appellees. With him on the brief were Stuart F. Delery , Principal Deputy Assistant Attorney General, Maame Ewusi-Mensah Frimpong , Deputy Assistant Attorney General, William B. Schultz , Acting General Counsel, U.S. Department of Health and Human Services, and Eric M. Blumberg , Deputy Chief Counsel, Litigation.

Opinion for the Court filed by Senior Circuit Judge SENTELLE.

SENTELLE, Senior Circuit Judge:

AstraZeneca Pharmaceuticals LP, a manufacturer of pharmaceutical products, appeals from the district court's grant of summary judgment in an action praying a declaratory judgment that the Food and Drug Administration ("FDA") could not approve generic versions of its Seroquel product and seeking to restrain the FDA from approving abbreviated new drug applications ("ANDAs") for such competing...

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