Federal Circuit Signals Reigning In Of Janssen And Rasmusson On Enablement/Utility

On Friday, July 29, 2011, the Federal Circuit issued a decision reversing the District of New Jersey's ruling that patent claims covering the use of tomoxetine (marketed as Strattera®) to treat attention deficit/hyperactivity disorder (''ADHD'') are invalid for lack of ''enablement/utility.'' Eli Lilly & Co. v. Actavis Elizabeth LLC, No. 2010-1500 (Fed. Cir. July 29, 2010). Read the decision here. Although nonprecedential, the opinion is important in that it indicates that at least certain members of the court recognize that the recent enablement/utility decisions in Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005), and Janssen Pharmaceutica N.V. v. Teva Pharmaceuticals USA, Inc., 583 F.3d 1317 (Fed. Cir. 2009), are limited to their facts, and do not establish any general rule requiring experimental data to support the utility of method-of-use claims.

The '590 patent-in-suit covers a method of treating ADHD by administering ''an effective amount of tomoxetine.'' At the time the '590 patent application was filed, tomoxetine was a known compound that had been proven safe, but not medically effective, in clinical trials aimed at treating depression and urinary incontinence. Slip Op. at 5. The '590 application disclosed the use of tomoxetine to treat ADHD, but did not include any data in support of this claim given the then-absence of any animal model for experimental evaluation of potential ADHD treatments and the inability to test for any effect on ADHD in humans without FDA authorization. Id. at 5, 12. Human test data demonstrating the effectiveness of tomoxetine in treating ADHD was obtained, however, during the prosecution of '590 application. Id. at 6.

In its earlier Rasmusson decision, the Federal Circuit explained that ''the how to use prong of section 112 [concerning enablement] incorporates as a matter of law the requirement of 35 U.S.C. § 101 that the specification disclose as a matter of fact a practical utility for the invention.'' 413 F.3d at 1323 (quoting In re Cortright, 165 F.3d 1353, 1356 (Fed. Cir. 1999)). Relying on Rasmusson and the above-mentioned Janssen decision, the district court ''held that utility was not established because experimental data showing the results of treatment of ADHD were not included in the specification.'' Slip Op. at 11, 16.

In reversing the district court, the Federal Circuit explained that such data is not required because an assertion of utility in the specification '''must...