Docket No. 2010-1500
NEWMAN, FRIEDMAN, LOURIE
July 29, 2011
Subject matter: enablement, utility, obviousness
Brief summary: contrary results / expert witness testimony crucial in obviousness; utility statements “must be taken as in compliance…unless there is reason to doubt”; inducement to infringe found because “atomoxetine [is] labeled solely for use to treat ADHD”; contributory infringement liability not avoided if the product has off-label uses
Summary: Lilly successfully appealed DC decision that its ‘590 patent related to the use of the drug atomoxetine / tomoxetine (Strattera®) to treat attention-deficit/hyperactivity disorder (ADHD) was invalid for lack of utility. As of the ‘590 filing date, tomoxetine was known to have failed Phase II and III clinical trials for urinary incontinence and Phase III clinical trials for treatment of depression. The tomoxetine ADHD clinical trial was authorized on Jan. 3, 1995 and the patent application filed on Jan. 11, 1995. The product initially approved by the FDA on Nov. 26, 2002. Actavis unsuccessfully argued to the DC that the claimed use would have been obvious (or at least obvious to try) because the inventors simply “substituted one potent selective norepinephrine reuptake inhibitor (atomoxetine) for another (desipramine) known to be effective in treating ADHD.” The FC found no error in the DC decision because “evidence was contrary to the likelihood that atomoxetine would be effective to treat ADHD..[it] was known not to be an effective antidepressant” due to significant side effects, and experts from both sides agreed the results were unexpected. The FC disagreed with the DC that the patent only enabled immediate release products, finding that only a “reasonable amount of experimentation” was required to establish effective dosages and formulations (citing Enzo, FC 1999 and BMW, FC 2007). The DC had also held the claims invalid for “‘enablement/utility’…because experimental data showing the results of treatment of ADHD were not included in the specification” but the FC disagreed (citing MPEP 2107.03 (8th Ed.) (“as a general rule” clinical trials understood as “reasonably predictive of having the asserted therapeutic utility”); In re Lana (CCPA 1974) / In re Brana (FC 1995) / In re Marzocchi (CCPA 1971) (statement in specification “must be taken as in compliance…unless there is reason to doubt”). Regarding infringement, the FC agreed with the DC that Actavis was liable for inducement to infringe because “atomoxetine [is] labeled solely for use to treat ADHD” (citing Astrazeneca, FC 2010 (“product label authorizing the patented use…’would inevitably lead some consumers to practice the claimed method'”; DSU Medical, FC 2006). However, it disagreed with the DC that “liability is avoided if the product has any ‘frequent’ non-infringing use” (under 35 USC 271(c)) ((e.g., off-label use) because the “defendants are restricted from selling a federally regulated drug for unapproved uses”.