05th July, 2017
The so-called “promise doctrine” is rejected.
In a landmark decision, the Court indicated that a patent providing at least one credible use related to the subject-matter of the invention was sufficient to establish utility. Credible utility is established by either demonstration or sound prediction as of the filing date. The rationale of this Supreme Court decision followed the arguments presented by counsel for FICPI.
On 30 June 2017, the Supreme Court of Canada overturned lower court decisions invalidating Canadian patent 2,139,653 which claimed the gastric acid lowering drug (proton pump inhibitor) sold under the Nexium™ brand.
Lower courts had found the patent invalid because of the so-called “promise doctrine” in that the patent specification promised more than what was soundly predicted at the filing date. The Trial Division of the Federal Court had termed the “promise of the patent” as “the yardstick against which utility is measured”.
Two so-called promises were identified:
- that the drug would work as a proton pump inhibitor in that it would reduce gastric acid; and
- that the drug would yield improved pharmacokinetics with less variations in individual patient response.
The first promise was not in dispute but the second one was deemed unfulfilled and led directly to a finding of invalidity; the Federal Court of Appeal affirmed. However, the Supreme Court unequivocally rejected the “promise doctrine” and reversed the findings of the lower courts.
The “promise doctrine” was deemed to be the wrong approach, being unsound and risking to deprive an otherwise useful invention of patent protection. Moreover, the “promise doctrine” was found to be antagonistic to the bargain on which patent law is based wherein inventors are asked to give fulsome disclosure in exchange for a limited monopoly.
The Supreme Court ruled that a patent providing at least one credible use related to the nature of the subject-matter of the invention was sufficient to establish utility. Credible utility is established by either demonstration or sound prediction as of the filing date.
Much of the rationale of this landmark decision of the Supreme Court followed the arguments presented by FICPI, acting as intervener and present at the Court Hearing held in November 2016 before a full panel of nine Supreme Court Justices.
FICPI was jointly represented on a pro-bono basis by Fasken Martineau DuMoulin LLP attorneys Julie Desrosiers, Marie Lafleur and Kang Lee and by Goudreau Gage Dubuc LLP attorney and FICPI member, Alain M. Leclerc.
A link to the decision may be found here: AstraZeneca Canada Inc. v. Apotex Inc.
Alain M. Leclerc
Vice President - Professional Excellence Commission