In Galderma Canada Inc. v. Canada (Attorney General), 2024 FCA 208, the Federal Court of Appeal (FCA) confirmed that the Patented Medicine Prices Review Board (PMPRB) does not have jurisdiction over unpatented medicines.

In this decision, the FCA considered the test of when a particular patent applies to a medicine (i.e. making it a patented medicine). Specifically, an invention in a patent may be said to cover a medicine when the invention is “intended or capable of being used for” the medicine or for the preparation or production of the medicine. However, the FCA clarified that this test should not be interpreted as expanding the PMPRB’s jurisdiction to include unpatented medicines, even if an existing patent might relate to the medicine in question.

The case at hand involved the PMPRB’s decision that the patent for DIFFERIN XP (relating to the use of 0.3% adapalene) covered the unpatented 0.1% adapalene product, DIFFERIN, due to clinical similarities between the two formulations (DIFFERIN was previously a patented medicine, but the patent had expired). The PMPRB initially asserted jurisdiction over the DIFFERIN product, requiring Galderma Canada to provide pricing and other information regarding DIFFERIN. The Federal Court upheld the PMPRB’s decision, finding it reasonable. However, the FCA ultimately set aside the PMPRB’s decision, reinforcing the limits of the PMPRB’s jurisdiction to patented medicines only.

The full case can be found here.