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The Federal Circuit Solidifies The Future For Subsequent ANDA Litigation

Posted in Federal Circuit Decisions

In Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., the Federal Circuit addressed complicated subject matter jurisdiction issues in the context of a declaratory judgment (DJ) action that was brought in accordance with the Hatch-Waxman Act by a subsequent ANDA filer. The court determined that the DJ action should proceed, even though the patent owner could not have brought an infringement action to enforce the challenged patents. The court’s decision may encourage DJ actions by other subsequent ANDA filers, with the potential to hasten the market entry of more generic drug products.

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