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Teva Pharm., USA, Inc. v. Eisai Co. Ltd., 09-1593, concerned a challenge to the district court's judgment dismissing the case for lack of jurisdiction, in an action for a declaratory judgment brought by Teva Pharmaceuticals, Inc. (Teva), that its generic version of the drug donepezil does not infringe four of defendant's Orange Book patents for use in treating Alzheimer's disease.
In reversing the district court's dismissal, the court remanded the matter as, Teva has alleged a sufficiently concrete injury fairly traceable to defendant's actions, and the injury can be addressed by the requested relief where a declaratory judgment of noninfringement would trigger the first-filer's exclusivity period, which currently blocks FDA approval of the Gate ANDA.
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