Recently, Canadian practice has evolved in a positive direction. New guidelines issued by the Canadian Intellectual Property Office (CIPO) in 2026 clarify that a dosage regimen is not automatically excluded from patentability. This approach has also been reinforced by a recent decision of the Supreme Court of Canada in Pharmascience v. Janssen (2026 SCC 26), in which the validity of claims directed to a dosage regimen was upheld.
According to this decision, inventions relating to new dosage regimens may or may not be patentable depending on the role of the healthcare professional. The more the implementation of the treatment requires individualized medical judgment, the greater the risk that the claim will be regarded as an unpatentable method of medical treatment. Conversely, where a dosage regimen can be applied according to predefined parameters, patent protection may be available.
For example, a claim defining a dosage range may be considered patentable if it can be demonstrated that all claimed doses are suitable for the intended patient population. By contrast, a treatment requiring case-by-case dosage adjustments based on a patient's condition is more likely to be regarded as unpatentable.
Key takeaway: CIPO's guidelines and the recent Supreme Court decision now confirm that dosage regimens are not inherently excluded from patentability in Canada, opening new opportunities for protecting this type of invention. The crucial question remains whether the implementation of the regimen requires the exercise of medical judgment.
Our team would be pleased to assess the patentability of your therapeutic innovations and assist you in defining the most appropriate protection strategy in Canada (or elsewhere!).
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