Teva Pharmaceuticals, USA, Inc. v. United States Food & Drug Administration
Court of Appeals for the D.C. Circuit
1Opinion of the Court
Opinion for the Court filed by Circuit Judge ROGERS.
ROGERS, Circuit Judge:
Teva Pharmaceuticals and Purepac Pharmaceutical Company appeal the denial of injunctive relief requiring the Food and Drug Administration (“FDA”) to recognize the dismissal of a declaratory judgment complaint for patent infringement as a “court decision” under the Abbreviated New Drug Application (“ANDA”) statute. See 21 U.S.C. § 355(j)(5)(B)(iv)(II) (Supp. Ill 1997). Appellants are “subsequent” ANDA applicants hoping to market ticlopi-dine tablets, a generic version of the name-brand drug “Ticlid,” used to treat stroke…
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