2:24-cv-04404
D.N.J.Aug 28, 2024Background
- Teva filed a complaint against Deva alleging infringement of nine patents related to the ProAir® HFA (albuterol sulfate) inhalation aerosol, following Deva's submission of an ANDA to market a generic version.
- Each of the nine patents forms the basis for two asserted claims: infringement under 35 U.S.C. § 271(e)(2) and a declaratory judgment of future infringement.
- Deva moved to dismiss for lack of subject matter jurisdiction under Rule 12(b)(1), challenging both the infringement and declaratory judgment claims.
- Deva argued (1) no infringement under § 271(e)(2) because none of Teva’s nine patents actually claim a "drug" and (2) insufficient immediacy for declaratory relief.
- The court ordered supplemental briefing regarding whether the asserted patents claim a "drug" for purposes of § 271(e)(2), referencing a pending Federal Circuit appeal in a related case (Teva v. Amneal).
- The court’s decision addresses immediate jurisdictional issues but reserves some questions for later resolution pending the related appeal.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Declaratory Judgment Jurisdiction | Facts allege a real and substantial controversy sufficient for declaratory relief | Complaint lacks sufficient immediacy—no imminent FDA approval or marketing | Court DENIED motion to dismiss; controversy is substantial |
| Infringement under § 271(e)(2) | Motion should be stayed pending Teva v. Amneal appellate result | Patents do not claim a drug, so no infringement possible | Decision RESERVED pending appeal in Teva v. Amneal |
Key Cases Cited
- Glaxo Inc. v. Novopharm Ltd., 110 F.3d 1562 (Fed. Cir. 1997) (standard for declaratory judgment jurisdiction in the Hatch-Waxman context)
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) (Supreme Court lowered the bar and clarified standards for declaratory judgment jurisdiction)
- Teva Pharms. USA, Inc. v. Novartis Pharms. Corp., 482 F.3d 1330 (Fed. Cir. 2007) (Hatch-Waxman act ANDA controversies generally create justiciable disputes)