In Dey Pharma, LP v. Sunovion Pharmaceuticals, Inc., the Federal Circuit affirmed the district court’s determination that it could exercise jurisdiction over a declaratory judgment action brought by a subsequent ANDA filer. This case follows earlier decisions in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd., Caraco Pharmaceutical Laboratories, Ltd. v. Forest Laboratories, Inc. and Janssen Pharmaceutica, N.V. v. Apotex, Inc., which I discussed in this article, and addresses the circumstances under which a subsequent ANDA filer can bring a declaratory judgment action to challenge Orange Book listed patents when the first ANDA filer has not yet entered the market.Continue reading this entry
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.