## Facts

- The asserted patent, U.S. Patent No. 4,663,318, claimed a method of treating Alzheimer’s disease and related dementias by administering galantamine (or a pharmaceutically acceptable salt) in a “therapeutically effective amount.”
- The specification relied primarily on animal testing conducted in animals with normal brains and referenced human clinical research that was ongoing rather than completed when the patent issued in May 1987.
- During prosecution, the applicant distinguished prior art animal studies on the ground that they were not Alzheimer’s-relevant and represented that more direct testing was underway; the referenced human testing was completed after issuance (July 1987).
- Janssen acquired rights to the patent and later obtained regulatory approval (around 2001) to market galantamine for Alzheimer’s disease.
- Generic manufacturers (including Teva and others) filed ANDAs seeking approval to market generic galantamine products; Janssen sued for infringement in consolidated litigation in the District of Delaware.
- The generic defendants did not dispute infringement if the patent were valid, but challenged validity, including for lack of enablement under 35 U.S.C. § 112.
- After a bench trial, the district court held the asserted claims invalid for lack of enablement, finding the disclosure required undue experimentation to practice the claimed treatment.

## Issues

1. Whether the ’318 patent’s specification enabled a person of ordinary skill in the art to practice the claimed method of treating Alzheimer’s disease with galantamine without undue experimentation, as required by 35 U.S.C. § 112.
2. Whether reliance on non-disease-model animal data and references to incomplete human studies, without concrete dosing or treatment guidance, can satisfy enablement for a method-of-treatment claim.

## Decision

- The Federal Circuit affirmed the district court’s judgment that the asserted claims were invalid for lack of enablement.
- The majority held the specification did not teach an operative method of treating Alzheimer’s disease with galantamine at the relevant time because it provided only starting points for further research.
- The court emphasized that the patent lacked completed human clinical evidence of efficacy for Alzheimer’s disease and did not supply adequate dosing or regimen guidance.
- The court concluded that determining effective and safe treatment parameters would require substantial, uncertain clinical work amounting to undue experimentation.
- Judge Gajarsa dissented, arguing the defendants failed to prove non-enablement by clear and convincing evidence and that the disclosure, viewed with then-existing scientific knowledge, was sufficient.

## Legal Principles

- Enablement under 35 U.S.C. § 112 requires the specification to teach skilled artisans to make and use the full scope of the claimed invention without undue experimentation.
- For method-of-treatment claims, enablement includes sufficient teaching that the method is efficacious for the claimed indication; a disclosure that functions primarily as a research proposal may be non-enabling.
- Animal data and prophetic or in-progress work can support enablement in some circumstances, but the specification must still provide credible, specific guidance that reasonably teaches how to practice the claimed therapeutic method.
- A claim term like “therapeutically effective amount” does not itself supply enablement; the disclosure must provide enough information (including, when necessary, dosing or regimen guidance) to avoid requiring extensive trial-and-error clinical investigation.

## Conclusion

The Federal Circuit held the ’318 patent invalid for lack of enablement because its disclosure—centered on non-Alzheimer’s animal studies, incomplete clinical research, and absent dosing guidance—required undue experimentation to carry out the claimed method of treating Alzheimer’s disease with galantamine.


In re ’318 Patent Infringement Litigation, 583 F.3d 1317 (Fed. Cir. 2009)