Eli Lilly & Co. v. Teva Canada Ltd., 2011 FCA 220 (July 5, 2011)

The Court of Appeal upheld the trial judge’s decision invalidating Lilly’s patent for lack of utility.  The patent covered the use of the drug atomoxetine for the treatment of attention deficit hyperactivity disorder (ADHD).

Evans J.A., writing for the Court, identified the principal issue between the parties as  whether the “MGH” clinical trial conducted prior to the filing date of the patent was sufficient to demonstrate that the invention was useful within the meaning of section 2 of the Patent Act.  The Court characterized this as essentially a factual issue.

Lilly’s argument that the trial judge had required the patent to meet an implied promise that atomoxetine would be useful “in the longer term” was rejected. The Court disagreed that this was an implied promise indicating that the trial judge was simply interpreting what “treatment” means in this patent in the context of ADHD, a chronic disorder requiring sustained treatment.

With respect to the quantum of utility required, the Court held that a low level or scintilla of utility would not suffice, since the patent had promised “that atomoxetine is a clinically effective treatment of ADHD”.

The Court upheld the trial judge’s  conclusion that this promise had not been demonstrated at the relevant date and  cautioned against trying to compare a factual situation in one patent case (i.e. where a small clinical study was sufficient to demonstrate utility) with another patent case.

On the issue of sound prediction, the Court upheld that trial judge’s decision that Lilly could not rely on sound prediction because it had not disclosed the MGH study in the patent. Despite that the patent resulted from a PCT application (Patent Cooperation Treaty incorporated into domestic law by Rule 51 of the Patent Rules), the Court stated that Article 27(4) of the Treaty, which allows an applicant to insist that the requirements of the Treaty be applied for matters of form and contents, was not of assistance since this was a substantive requirement. The Court followed its 2009 decision in Eli Lilly Canada Inc. v. Apotex Inc., 2009 FCA 97 requiring disclosure in the patent itself.

The full text of the decision can be found at:

http://www.gowlings.com/knowledgeCentre/enewsletters/pharmacapsules/pdfs/A-387-10.pdf