## Facts

- Novartis held the NDA for Famvir® (famciclovir) and listed five Orange Book patents: one active-ingredient patent and four method-of-use patents.
- Teva filed an ANDA for generic famciclovir tablets with paragraph IV certifications asserting noninfringement and/or invalidity as to all five patents.
- Novartis sued Teva for infringement only on the active-ingredient patent, triggering Hatch-Waxman litigation as to that patent alone.
- Teva filed a separate declaratory-judgment action seeking declarations of noninfringement and invalidity for the four method-of-use patents to eliminate barriers to approval and launch.
- Novartis refused to provide a covenant not to sue on the four method patents and moved to dismiss Teva’s declaratory action for lack of Article III jurisdiction.
- The district court dismissed, applying a preexisting Federal Circuit test requiring a reasonable apprehension of imminent suit.
- While Teva’s appeal was pending, the Supreme Court decided MedImmune, rejecting a rigid reasonable-apprehension requirement for declaratory-judgment jurisdiction.
- The method-of-use patents extended beyond the active-ingredient patent’s expiration, so they could continue to affect Teva’s ability to enter the market even if Teva prevailed in the active-ingredient case.

## Issues

1. Whether, after MedImmune, a declaratory-judgment plaintiff must show a “reasonable apprehension of imminent suit” to establish an Article III case or controversy in a patent dispute.
2. Whether an ANDA filer has Article III jurisdiction to seek declaratory relief on Orange Book–listed method-of-use patents when the patentee sued only on a different listed patent and refused to covenant not to sue.

## Decision

- The Federal Circuit reversed the dismissal and remanded.
- The court held that MedImmune displaced the Federal Circuit’s prior “reasonable apprehension of suit” test for declaratory-judgment jurisdiction.
- Applying an “all the circumstances” inquiry, the court concluded Teva alleged a substantial, immediate, and real controversy with Novartis concerning the four method-of-use patents.

## Legal Principles

- Declaratory-judgment jurisdiction in patent cases turns on whether, under all the circumstances, there exists a substantial controversy between parties with adverse legal interests, of sufficient immediacy and reality to warrant judicial relief.
- A patentee’s decision to sue on only some Orange Book–listed patents does not, by itself, defeat Article III jurisdiction over declaratory challenges to other listed patents that continue to affect the ANDA filer’s legal position.
- In the Hatch-Waxman context, an ANDA with paragraph IV certifications can create adverse legal interests regarding listed patents, and declaratory relief may redress ongoing uncertainty affecting approval and market entry.
- Refusal to provide a covenant not to sue is a relevant circumstance in assessing whether a real and immediate controversy exists.

## Conclusion

The Federal Circuit held that, after MedImmune, Teva was not required to show a reasonable apprehension of imminent suit to pursue declaratory judgments on Orange Book–listed method-of-use patents; considering all circumstances in the Hatch-Waxman setting, Teva established an Article III controversy, so dismissal for lack of jurisdiction was reversed and the case remanded.


Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp., 482 F.3d 1330 (Fed. Cir. 2007)