Dosage Regimens Affirmed In Canada Again

The Commissioner's Decision Re Genentech, Inc.  (2021 CACP 8) is the most recent case to consider medical use claims following the clarification of patentable subject matter in the CIPO guidance document (PN2020-04). The Patent Appeal Board allowed medical use claims reciting a mg/kg dosage regimen in Genentech's Canadian Patent Application 2,382,100 (the '100 application).

In Canada, methods of medical treatment are not patentable subject-matter, but medical use claims can be considered patentable. PN2020-04 notes that, in determining patentability it is necessary to consider whether professional skill and judgment is part of the actual invention. Examples of situations in which the exercise of skill and judgment would be required include those in which a medical professional would be expected to monitor or adjust treatment, or where not all doses from a claimed range will work for all subjects. In such instances, the necessity of professional skill and judgment