Duplicative Declaratory Judgment Infringement Allegations Are Duplicative and Unnecessary ANDA Actions

Plaintiffs in ANDA actions frequently include declaratory judgment infringement allegations under § 271(a) – (c) (the section of the statute governing traditional patent infringement cases) in addition to § 271(e)(2) (the section of the statute  governing Hatch Waxman actions).  Although the case law is unsettled, defendants have successfully obtained dismissals of duplicative declaratory judgment infringement claims.

The Northern District of California recently addressed this issue in Takeda Pharm. Co. v. Mylan Inc., 2014 U.S Dist. LEXIS 105861, an ANDA case involving Mylan’s efforts to obtain approval to market a generic version of Takeda’s Dexilant.  Takeda asserted infringement under § 271(e)(2) and declaratory judgment claims of infringement under  § 271(a)-(c).  Mylan moved to dismiss for the declaratory judgment § 271(a)-(c) claims for lack of subject matter jurisdiction.

Declaratory judgment jurisdiction is proper where there is a substantial controversy between parties having adverse legal interests of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.  Mylan contended that there was no immediate and real controversy over the § 271(a) – (c) claims because the 30-month stay did not expire until 2016, trial was not scheduled until November 2015, the FDA had not approved the ANDA and Mylan had not declared its intent to launch.  Conversely, Takeda argued it was entitled to maintain both claims because filing an ANDA sufficiently provides a controversy and Mylan had made substantial preparation toward infringement.

The Court declined to decide whether an immediate and real controversy existed, noting that the case law is unsettled on the issue of whether a controversy exists sufficient to establish subject matter jurisdiction over the § 271(a)-(c) claims.  However, the Court exercised its discretion to decline jurisdiction over the declaratory judgment claims, finding that they served no useful purpose and were unnecessary and duplicative of § 271(e)(2).  In particular, the Court found that § 271(e)(2) was created specifically for ANDA proceedings and would resolve the same issues as the §271(a)-(c) claims, including indirect infringement and damages after a generic launch.  Consequently, the Court dismissed the declaratory judgment claim without prejudice.   With this case in mind, Defendants should consider moving to dismiss duplicative declaratory judgment infringement claims.