Novopharm Limited v. Eli Lilly and Company (2010 FC 915)

T-811-08

Successful impeachment action, STRATTERA, September 14, 2010

An impeachment action was brought by Novopharm in respect of a patent for STRATTERA alleging obviousness, anticipation, utility and improper selection. Novopharm failed on obviousness, anticipation and improper selection, but the Court found in their favour on utility.

The patent claimed the new use (i.e. second medical use) of atomoxetine for treating ADHD. In respect of the obviousness attack, Mr. Justice Barnes found that it was not self-evident that it would work and Novopharm’s witnesses applied hindsight. Furthermore, any testing that would be required to demonstrate the efficacy of the drug would be more than routine. Even a high level of motivation to take a particular step cannot transform a possible solution into an obvious one.

In respect of anticipation, the Court rejected two instances of alleged anticipatory disclosure. First, a conversation that took place between an inventor and one of the Novopharm witnesses 18 years ago was rejected due to inconsistencies between the witness’ testimony in court and a report the witness wrote soon after the meeting. Second, a discussion between the inventor and a hospital representative regarding engaging the hospital in research with atomoxetine was also rejected as it did not put the inventive idea into the public domain - these types of discussions are presumed to be in confidence.

In respect of the utility attack, the Court found that the promise of the patent is that atomoxetine is clinically useful for treating ADHD. The Court held that a pilot study conducted on behalf of Eli Lilly at the time had a number of methodological limitations and did not demonstrate utility. When assessing utility according to the sound prediction route, the Court held that the failure to include or disclose the findings of the study in the patent meant that the test for sound prediction was not satisfied.