An application for leave to appeal the decision in Pharmascience Inc v. Janssen Inc. (2024 FCA 23) was recently filed by Pharmascience in the Supreme Court of Canada (SCC).

In the Federal Court of Appeal (FCA) decision, the FCA upheld the Federal Court’s finding that the claims of the relevant patent owned by Janssen reciting a dosing regimen did not comprise unpatentable methods of medical treatment and were valid. The FCA noted, in part, that “whether… a dosing regimen relates to a method of medical treatment cannot be based exclusively on whether its dosing and schedule is fixed or not” and “[t]he proper inquiry remains whether use of the invention… requires the exercise of skill and judgment” (at para 37). The Court also stated that it would be difficult to provide more detailed guidance on this issue since allegations that claims are invalid due to claiming methods of medical treatment will generally turn on the particulars of the case and the evidence on record (at para 37).

If leave to appeal is granted by the SCC, this would give the SCC an opportunity to consider and potentially clarify the framework for assessing the patentability of methods of medical treatment.

Read the FCA’s decision here. View the Supreme Court of Canada case information for this leave to appeal here.