New Implications to off-patent versions of a patented drug

According to a recent Federal Court ruling, PMPRB’s jurisdiction over patented drug prices could also apply to an off-patent drug. Torys summarizes the Galderma case of Differin, a 0.1% formulation of adapalene, and Differin XP, a sustained release 0.3% formulation. The patent for Differin expired in 2009 and for Differin XP in 2016. The PMPRB believed that between the years of 2009 and 2016, Differin was still under PMPRB jurisdiction and sales and pricing information should have been provided to the Board. Over the next several years, the case of whether or not Differin should have been under PMPRB jurisdiction by virtue of the Differin XP patent played out in the Courts.

Court Decisions

• 2017 - the Federal Court ruled that the PMPRB did not have this jurisdiction (saying it was unreasonable (and irrelevant) to conclude that a patent for Differin XP is capable of being used for Differin) and the PMPRB appealed
• 2019 - the Federal Court of Appeal granted the appeal and remitted the matter to the PMPRB for redetermination on whether Differin XP had any clinical similarities with Differin that would support a finding that the Differin XP patent was intended or capable of being used for Differin
• 2020 – Upon redetermination the PMPRB’s view remained that it did have jurisdiction over Differin given the clinical similarities as the two products were the same medicinal ingredient, shared a product monograph, had similar clinical effects and side effects and a similar indication. Galderma, again, sought judicial review of the PMPRB’s redetermination decision
• 2022 – After the PMPRB redetermination, Galderma unsuccessfully sought to file additional evidence with the Federal Court to show the clinical differences between Differin and Differin XP

Current Decision Even though the two products are not interchangeable, and Differin XP works more rapidly and with a greater therapeutic effect, the Federal Court did agree with the PMPRB regarding the clinical similarities and as such ruled the PMPRB did have jurisdiction over the off-patent, Differin.

Torys highlights that the case “redefines the “medicine” as the medicinal ingredient rather than the commercial preparation”. The law firm encapsulates the decision, “if a manufacturer obtains a patent for a new dosage form, new formulation, or new combination medicine based on an active ingredient used in an older off-patent medicine, the PMPRB may re-assert jurisdiction over the off-patent medicine.”

Galderma has 30 days to appeal from January 11, 2024.

If you have any questions, please don’t hesitate to contact Suzanne Solman at (ssolman@pangaea-consultants.com)[ssolman@pangaea-consultants.com] or Ben Parry at (bparry@pangaea-consultants.com)[mailto:bparry@pangaea-consultants.com]