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Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd. (Fed. Cir. 2010)

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- The Federal Circuit expanded the scope of Article III jurisdiction under the Declaratory Judgment Act (28 U.S.C. § 2201) in the Hatch-Waxman context in Teva Pharmaceuticals USA, Inc. v. Eisai Co., Ltd. Specifically, the Court held that listing patents on the Orange Book could provide a sufficient injury-in-fact for an Abbreviated New Drug Application (ANDA) filer to assert an actual controversy, when its entry into the marketplace is blocked by a prior first ANDA filer. Teva, and its subsidiary Gate Pharmaceuticals, each filed an ANDA for different generic versions of donepezil hydrochloride, a drug for...

Full post as published by Patent Docs on October 13, 2010 (boomark / email).