Supreme Court confirms methods of medical treatment are unpatentable in Canada and clarifies test
The SCC addressed the parties’ arguments regarding the Canadian prohibition on patenting methods of medical treatment. Pharmascience brought the appeal seeking to have Janssen’s dosing regimen patent declared invalid as an unpatentable method of medical treatment, which would have allowed Pharmascience to market its generic paliperidone product. However, Pharmascience’s appeal was dismissed, and the validity of Janssen’s patent was upheld.
The SCC provided two sets of reasons, a majority decision written by Jamal J., and a minority concurring decision written by O’Bonsawin and Moreau JJ.
Jamal J. rejected the “extreme” positions advanced by both parties and affirmed and endorsed the “balanced approach” of the Federal Court of Appeal, which confirmed that methods of medical treatment remain unpatentable in Canada.
Jamal J. did not introduce a new test, but clarified that the existing jurisprudence applies, and that the approach to the determination will be fact-based:
- The analysis should focus on whether the subject matter of the claimed invention amounts to professional medical skill and judgment, not whether professional medical skill and judgment would be applied in selecting the claimed invention for a particular patient or use;
- The more the practice of a claimed invention involves tailoring it to the circumstances of a particular patient, the more likely it is that its subject matter amounts to professional medical skill and judgment; and
- The application of the test must remain focused on the purpose of the rule that methods of medical treatment are unpatentable subject matter: methods of medical treatment need not be incentivized through the patent bargain because medical professionals are expected to innovate within their areas of professional practice regardless of such an incentive.
Jamal J. noted the importance of certainty and predictability in the law, observing that the Court should not take lightly a request to overturn its own precedent. Janssen and several intervenors submitted that no legal basis remained for excluding methods of medical treatment from patentability, as was decided in Tennessee Eastman Co v Commissioner of Patents, [1974] SCR 111. Jamal. J rejected this submission to overrule its own precedent.
Jamal J. upheld the analysis by the Courts below which found that the dosing claims in issue did not claim a method of medical treatment because it did not impinge upon professional medical skill and judgment.
O’Bonsawin and Moreau JJ. concurred in the result, but wrote separate reasons in which they would overrule the precedent in Tennessee Eastman and conclude that patents in Canada may claim methods of medical treatment. Although their detailed reasons span 160 paragraphs, they primarily argue that the prohibition on patents for methods of medical treatment is outdated and unworkable. They suggest that their approach “merely represents a recalibration” because the existing utility requirement in Canadian patent law will prevent the patenting of certain methods of medical treatment. This analysis was soundly rejected by the majority.
If you wish to learn more about this decision, sign up for IPIC’s webinar on Thursday, August 13 at 1:00pm entitled “Methods of Medical Treatment: Unpacking the SCC’s Decision in Pharmascience v. Janssen.” Aitken Klee Partner, Bryan Norrie, will be participating as a panelist.
