Case: Eli Lilly and Company v. Teva Canada Limited
Drug: Atomoxetine (Strattera®)
Nature of case: Appeal from an impeachment action
Successful party: Teva Canada Limited
Date of decision: July 5, 2011
On July 5, 2011, the Federal Court of Appeal (“Court of Appeal”) dismissed Eli Lilly and Company’s (“Lilly”) appeal from a Trial Judgment declaring Canadian Patent No. 2,209,735 (“’735 Patent”) to be invalid pursuant to Section 60(1) of the Patent Act, R.S.C. 1985, c. P 4 (“Patent Act”).
The Trial Judge had found that the ‘735 Patent was invalid for lack of utility. There was no dispute at trial as to the nature of the promise of the patent. However, the Trial Judge found a lack of evidence demonstrating the promised utility at the Canadian filing date. The Trial Judge also found that there was no sound prediction of utility because a clinical trial relied upon by Lilly in support of the factual foundation for the prediction was not disclosed in the ‘735 Patent.
Lilly appealed the Trial Judgment declaring the '735 Patent invalid. Three primary grounds were asserted by Lilly: (1) the Trial Judge went beyond the promise expressly made in the patent to find an implicit promise that atomoxetine “will work in the longer term”; (2) the Trial Judge held Lilly to an elevated standard of proof for demonstrated utility; and (3) that disclosure of the clinical trial in the patent was not required for there to be a sound prediction of utility.
- Construction of the promise
The Court of Appeal did not accept that the Trial Judge had gone beyond the promise expressly made in the patent, namely that atomoxetine is an effective treatment of ADHD.
- Sufficiency of evidence to demonstrate utility
Whether Lilly had sufficient evidence at the Canadian filing date to establish that atomoxetine would deliver on the promise of the patent was a question of fact on the basis of the evidence and the Trial Judge’s assessment of it. The Court of Appeal held that the Trial Judge made no palpable and overriding error in concluding that the promised utility was not demonstrated in the clinical study relied upon by Lilly. Although Lilly argued that a Phase 2 clinical trial exceeds the standard required for utility, the Court of Appeal disagreed because, in this case, the patent specifically promised that atomoxetine is a clinically effective treatment of ADHD.
- Disclosure requirement for sound prediction
The Court of Appeal confirmed the Trial Judge's finding that Lilly could not rely upon the principle of a sound prediction of utility because it had not disclosed the factual basis of the prediction, namely the clinical study, in the patent. The Court of Appeal held, that while this issue was not decided definitively in the Apotex v. Wellcome (AZT) case of the Supreme Court of Canada, subsequent appellate courts have since held that a “patentee must disclose in the patent a study that provides the factual basis of the sound prediction.”
The Trial Judge's determination on the issue of utility was found not to contravene international law. Article 27(5) of TRIPS does not limit the Contracting States’ freedom to prescribe substantive conditions of patentability, such as utility.
Link to decision:
Link to Pharma in brief dated September 22, 2010: