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ELI LILLY AND CO. v. ACTAVIS ELIZABETH LLC, Appeal No. 2010-1500 (Fed. Cir. July 29, 2011). Before Newman, Friedman and Lourie. Appealed from D.N.J. (Judge Cavanaugh). Background: Eli Lilly owns a patent directed to a method of treating attention-deficit/hyperactivity disorder (ADHD). The claim at issue recites: "A method of treating attention-deficit/hyperactivity disorder comprising administering to a patient in need of such treatment an effective amount of tomoxetine." The district court held the claim invalid for lack of "enablement/utility" (utility) because experimental data showing the results of treatment of ADHD were not included in the specification. Lilly appealed. Did the district court err in holding the claim invalid for lack of utility? Yes, reversed. The undisputed facts are: (1) the patent disclosed the use of tomoxetine to treat ADHD, but did not include any data; (2) human test data was not available at the time the patent application was filed, because human tests were prohibited without FDA authorization; (3) human test data showing the effectiveness of tomoxetine in treating ADHD was obtained shortly after the patent application was filed; and (4) during examination, the examiner had not requested additional information. When priority is not at issue, generally the applicant may provide data obtained either before or after the patent application was filed to support an assertion of utility. Post-filing evidence can be used to substantiate any doubts as to the asserted utility because this pertains to the accuracy of a statement already in the specification. The Federal Circuit noted that the utility of tomoxetine is accurately stated in the specification; there is no allegation of falsity in the disclosed utility; and the Examiner did not require the presentation of additional data. The Court held that the patent enables the utility of tomoxetine to treat ADHD. The defendants relied on Janssen v. Teva (Fed. Cir. 2009) where the court held that the use of galantamine to treat Alzheimer's disease was a "mere research proposal," and enablement was not shown. In Janssen, the specification merely summarized six scientific articles on the properties of galantamine and reporting brain effects in mammals, and the animal tests were not finished by the time the application was allowed. In Janssen, the Court held that there was not a reasonable correlation between a compound's activity and its asserted therapeutic use. In the present case, the Court distinguished Janssen, because in the case of tomoxetine, (1) other compounds in tomoxetine's class of drugs were known to treat ADHD; (2) tomoxetine's safety for antidepressant activity had been established; (3) the specification contained a full description of the utility; (4) experimental verification had been obtained before the patent was granted; and (5) the examiner had not requested additional information. Thus, the Federal Circuit held that, based on the evidence, invalidity for lack of utility was not shown by clear and convincing evidence. AQS

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