124 F.4th 898
Fed. Cir.2024Background
- Teva held FDA approval for ProAir® HFA, a metered-dose inhaler containing albuterol sulfate.
- Teva listed several patents in the FDA Orange Book for ProAir® HFA—these patents covered device components (e.g., dose counters), not specifically the active ingredient, albuterol sulfate.
- Amneal filed an ANDA to market a generic version, but because of Teva’s listed patents, was required to file a Paragraph IV certification, triggering a 30-month stay on FDA approval due to pending patent litigation.
- Amneal counterclaimed, seeking an order to require Teva to delist the device-component patents, arguing they did not claim the active ingredient as required by statute.
- The district court ruled in favor of Amneal, ordering delisting of the patents; Teva appealed and sought a stay, which the Federal Circuit lifted with this decision affirming the delisting order.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether "claims the drug" requires a patent to claim the active ingredient approved by the FDA | Teva’s patents need only claim some element of the NDA product | Amneal: Listing is only valid if patent claims the active ingredient (albuterol sulfate) | Affirmed: Patent must claim at least the active ingredient |
| Whether "claims" means "reads on" (i.e., covers any infringing product) | Teva: If NDA product infringes a patent, patent should be listed | Amneal: Only patents that particularly point out and distinctly claim the drug qualify | Court rejected Teva’s view; patents must uniquely claim the drug |
| Whether device patents (not claiming the drug's active ingredient) can be listed | Teva: FDCA defines “drug” broadly, so device claims suffice | Amneal: Device components alone are not drugs as intended by Orange Book | Only patents claiming the active ingredient are listable |
| Whether claim construction/remand was needed | Teva: District court should have construed the claims first | Amneal: No construction needed; device claims do not claim the drug | No remand required; under any construction, patents improperly listed |
Key Cases Cited
- Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (Supreme Court clarified "artificial" act of infringement for ANDA filings)
- Caraco Pharm. Labs., Ltd. v. Novo Nordisk A/S, 566 U.S. 399 (Supreme Court on Orange Book listing and Hatch-Waxman regime)
- United States v. Generix Drug Corp., 460 U.S. 453 (Supreme Court discussed pre-1984 generic drug approvals)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (Supreme Court on claim construction being a legal issue)
- Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17 (Supreme Court on doctrine of equivalents in patent law)
- Riegel v. Medtronic, Inc., 552 U.S. 312 (Supreme Court described medical-device versus drug regulatory pathways)
- Phillips v. AWH Corp., 415 F.3d 1303 (Federal Circuit en banc on patent claim interpretation)
- Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U.S. 476 (Supreme Court discussed infringement by combination products)