Drug: atomoxetine

Novopharm filed an ANDS with Health Canada for Novo-atomoxetine. Novopharm then started an action to impeach the patent Lilly had listed on the Patent Register for its product. Novopharm did not send a Notice of Allegation pursuant to the NOC Regulations.

The Court considered Novopharm’s obviousness allegations, however, held that Novopharm’s evidence was based on an ex post facto simplification of the problem and held that no one could have confidently predicted atomoxetine would be a successful ADHD drug. The profiles of drugs that work to treat ADHD were simply too diverse and their mechanism of presumed action within the highly complex neurological systems involved were too uncertain to draw any firm conclusion about the efficacy of atomoxetine. Thus, the Court held that Novopharm failed to establish that the inventive promise of the patent would have been obvious to a person skilled in the art. The Court also found that there was no disclosure of the use of atomoxetine to treat ADHD. Thus, the patent was not anticipated.

The Court then considered the issue of utility. It held that when the patentee asserts that the utility of its invention had been demonstrated it need not assert its supporting evidence in the patent. Such cases only require a full description of the invention and the means to work it. However, in cases involving a sound prediction of utility, an additional disclosure obligation arises as the patent must contain both the factual data upon which the prediction is based and the line of reasoning followed to enable the prediction to be made. In this case, the Court held that the study relied upon to show utility would not adequately demonstrate the clinical usefulness of atomoxetine to treat ADHD in adults, let alone in children and adolescents, as the clinical trial was too small and too short to provide anything more than interesting but inconclusive data. The Court then held that in some cases an initial study of this sort may provide a basis for sound prediction of utility. However, the study was not included in the patent as is required when relying on a sound prediction. Thus, the patent was invalid for lack of utility.