## Facts

- Warner-Lambert owned U.S. Patent No. 5,084,479, claiming a method of treating neurodegenerative diseases by administering certain compounds, including gabapentin.
- Warner-Lambert also held a separate patent claiming use of gabapentin to treat epilepsy/partial seizures.
- Gabapentin had FDA approval for treating partial seizures; it did not have FDA approval for the neurodegenerative indications claimed in the ’479 patent.
- Apotex filed an ANDA seeking FDA approval to market generic gabapentin only for the partial-seizures indication upon expiration of the epilepsy-method patent.
- Apotex submitted a Paragraph IV certification asserting its ANDA product and proposed use would not infringe the ’479 patent because the ANDA sought approval only for partial seizures, not neurodegenerative diseases.
- Warner-Lambert sued, alleging the ANDA filing infringed the ’479 patent under 35 U.S.C. § 271(e)(2) and that Apotex would indirectly infringe (inducement/contributory infringement) after market entry.

## Issues

1. Whether filing an ANDA seeking approval only for a use not claimed in the patent-in-suit constitutes infringement of a method-of-use patent under 35 U.S.C. § 271(e)(2).
2. Whether a patentee can maintain a present action based on alleged future inducement or contributory infringement of a method-of-treatment patent when the ANDA labeling and requested indication are limited to a non-claimed use.
3. Whether anticipated off-label prescribing can supply the infringement predicate for § 271(e)(2) liability or indirect infringement tied to an ANDA.

## Decision

- The Federal Circuit affirmed summary judgment of noninfringement for Apotex.
- Apotex’s ANDA filing was not an act of infringement of the ’479 patent under § 271(e)(2) because the ANDA sought approval only for treating partial seizures, a use not claimed in the ’479 patent.
- Warner-Lambert failed to show a basis for inducement because Apotex’s requested indication and proposed labeling did not encourage use for neurodegenerative diseases.
- Warner-Lambert failed to show contributory infringement because gabapentin had a substantial noninfringing use (treating partial seizures) and the ANDA targeted that use.

## Legal Principles

- Section 271(e)(2) creates a limited, premarketing “artificial” act of infringement that is tied to the use(s) for which the ANDA applicant seeks FDA approval.
- An ANDA does not infringe a method-of-use patent under § 271(e)(2) when the ANDA’s requested indication and labeling do not seek approval for any use claimed in the asserted patent.
- Method-of-treatment infringement requires performance of the claimed treatment method; speculation that physicians may prescribe a drug off-label does not establish infringement based on the ANDA filing alone.
- Inducement requires evidence of specific intent to encourage infringement; labeling and approval requests confined to a non-claimed use generally do not show the required intent.
- Contributory infringement requires lack of substantial noninfringing uses; a drug with an approved, substantial noninfringing indication defeats contributory infringement based solely on the ANDA submission.

## Conclusion

The Federal Circuit held that an ANDA seeking approval only for an unpatented indication does not infringe a different method-of-use patent under § 271(e)(2), and that conjecture about post-approval off-label use, without evidence of intent or lack of substantial noninfringing uses, cannot sustain inducement or contributory infringement claims at the ANDA stage.


Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348 (Fed. Cir. 2003)