Takeda Pharmaceutical Co. v. Mylan Inc.

ORDER GRANTING PARTIAL MOTION TO DISMISS

Plaintiffs Takeda Pharmaceutical Co. Ltd., Takeda Pharmaceuticals U.S.A., Inc., and Takeda Pharmaceuticals America, Inc. (collectively, “Takeda”) filed this patent infringement action against Defendants My-lan Pharmaceuticals Inc. and Mylan Inc. (collectively, “Mylan”).- See Compl. (ECF No. 1). Takeda’s claims relate to Mylan Pharmaceuticals Inc.’s filing of an Abbreviated New Drug Application (“ANDA”) for a generic form of Takeda’s branded drug Dexilant®, for treatment of gastroesopha-geal reflux disease. In its Complaint, Takeda pleaded two Counts. Count I is a claim for infringement under the Hatch-Waxman Act pursuant to 35 U.S.C. § 271 (e)(2). Id. ¶¶ 29-31 . Count II seeks a declaratory judgment of infringement under 28 U.S.C. § 2201 , “[pjursuant to 35 U.S.C. § 271 (a), (b), or (c).” Id. ¶¶ 32-38 .

Mylan moves to dismiss Count II under Fed.R.Civ.P. 12(b)(1) for lack of subject matter jurisdiction or, alternatively, for an order terminating the automatic stay of the Food and Drug Administration’s (“FDA”) approval of Mylan’s ANDA. See ECF No. 13 (“Mot.”) at 1. Mylan argues that the Court lacks jurisdiction over Count II under the…