In a recent decision of the Supreme Court of Canada (SCC), the Court dismissed an appeal in Pharmascience Inc. v. Janssen Inc., 2026 SCC 26, upholding Janssen's patent covering dosing regimens for a long-acting schizophrenia drug (paliperidone palmitate).
The decision leaves existing Canadian law intact and confirms that methods of medical treatment are not patentable because professional medical skill and judgment should not be monopolized by patents. However, in this particular case, the court held Janssen's patent valid because exercise of skill and judgment are not required to implement the claimed dosing regimen after the dosage regimen has been chosen.
In the majority decision, the "bright-line rules” approach based on whether a dosage regimen is "fixed" or "variable” was rejected. Instead, the SCC found that courts must look at whether the real subject matter of the claims amounts to professional medical skill and judgment, or not.
As always, when preparing patent claims for filing in Canada in the medical and pharmaceutical fields, it is important to conduct an initial assessment of whether the subject matter amounts to professional medical skill and judgement. In particular, consideration should be given to whether amendments to the claims should be made to facilitate allowance over a possible subject matter objection.
