## Facts

- Allergan owned two method-of-use patents covering administration of brimonidine for neuroprotection/optic nerve protection.
- Brimonidine as a compound was not patented, and the FDA had not approved brimonidine for the patented neuroprotective uses.
- Alcon and Bausch & Lomb filed ANDAs seeking approval to market generic brimonidine only for reduction of intraocular pressure, a use not claimed by Allergan’s patents.
- FDA regulation permits physicians to prescribe approved drugs off-label, and some state substitution laws can result in dispensing generics even when prescribed for off-label uses.
- Allergan alleged that approval and sale of generic brimonidine for the IOP indication would foreseeably lead to off-label use practicing the patented neuroprotective methods, and that the ANDA filings therefore supported induced infringement.
- The district court granted summary judgment of noninfringement to Alcon and Bausch & Lomb, concluding § 271(e)(2) did not provide a cause of action for induced infringement on these facts.

## Issues

1. Whether 35 U.S.C. § 271(e)(2) permits an induced-infringement action based on filing an ANDA that seeks approval only for a nonpatented use, where the drug could foreseeably be used off-label to practice an unapproved, patented method of use.
2. Whether the “artificial act of infringement” in § 271(e)(2) is determined by the use for which FDA approval is sought (and proposed labeling), rather than potential post-approval off-label use.

## Decision

- The Federal Circuit affirmed summary judgment of noninfringement.
- Filing an ANDA seeking approval only for a nonpatented indication did not constitute infringement under § 271(e)(2) of Allergan’s method-of-use patents for different, unapproved indications.
- Foreseeable off-label prescribing and state substitution practices did not convert the ANDA filing into actionable induced infringement at the pre-approval stage.

## Legal Principles

- Section 271(e)(2) creates a limited “artificial” infringement act tied to submission of an ANDA for a drug claimed in a patent or for a use claimed in a patent; the relevant “use” is the one for which approval is sought as reflected in the ANDA/proposed labeling.
- When an ANDA seeks approval for an indication not claimed by the asserted method patents, § 271(e)(2) does not provide a basis to litigate infringement based on other, unapproved method claims.
- Inducement requires active and knowing encouragement of another’s infringement; mere predictability that physicians may prescribe a generic off-label is not enough, by itself, to establish inducement from the ANDA filing.
- The Hatch–Waxman patent-listing and certification structure supports limiting § 271(e)(2) litigation to the patented drug or patented uses for which the ANDA seeks approval, leaving any later claims based on actual post-approval conduct to traditional infringement theories.

## Conclusion

The court held that an ANDA filing aimed at a nonpatented, different indication does not trigger § 271(e)(2) induced infringement liability based on expected off-label use of the generic drug to practice an unapproved, patented method of use.


Allergan, Inc. v. Alcon Lab'ys, Inc., 324 F.3d 1322 (Fed. Cir. 2003)