The Federal Court found that the PMPRB wrongly asserted jurisdiction over Differin® pricing based on an incorrect application of the patent-pertaining analysis. The Court allowed an application for judicial review by Galderma Canada Inc. (Galderma) from the PMPRB’s failure-to-file decision, holding that the PMPRB had failed to consider the entirety of Galderma’s patent when determining whether it pertained to Differin®.
Case: Galderma Canada Inc. v Canada (Attorney General), 2017 FC 1023 (Court File No. T-83-17)
Nature of case: Application for judicial review of a PMPRB Board Decision on the merits
Drugs: Differin® (adapalene 0.1% w/w) & Differin XPTM (adapalene 0.3% w/w)
Date of decision: November 9, 2017
Canadian Patent No. 2,478,237 (the 237 Patent) relates to the use of adapalene to treat dermatological disorders. Galderma markets two adapalene products:
- Differin® contains 0.1% adapalene.
- Differin XPTM contains a higher concentration of adapalene — 0.3%.
As we reported, in an application before a hearing Panel of the PMPRB, the Board staff successfully argued that the 237 Patent pertained to Differin®. Galderma argued that the 237 Patent is not intended or capable of being used to make Differin® — a 0.1% adapalene formulation — because on its face, the patent is specific to 0.3% adapalene formulations (such as Differin XPTM). The Panel did not accept that argument.
The PMPRB applied the wrong test
The Federal Court held that the central question the PMPRB had to address was whether the invention in the 237 Patent pertains to Differin®.
The Court held that the PMPRB misapprehended the question and engaged in an unreasonable analysis. In particular, the PMPRB did not consider the entire patent in its analysis and did not determine what the invention was. Instead, it incorrectly focussed on the commonality of medicinal ingredients between the drugs. This analysis was unsupported: there was no evidence that the invention of the 0.3% adapalene in the 237 Patent could be used for 0.1% adapalene formulation of Differin®.
In reviewing the PMPRB’s decision, Phelan J. held that “[t]he Board is entitled to deference on the scope of “pertains” so long as it asks the right question, and does not so stretch the application of “pertains” such that it strays into constitutionally impermissible grounds to regulate drug prices which are not sufficiently connected to a federal field of jurisdiction (i.e. patents).” Although the patent-pertaining analysis does not include claims construction, the PMPRB is nonetheless required to consider the entire patent, including the claims. While a holistic analysis is potentially reasonable, the Court rejected the PMPRB’s finding that the “patents pertaining” analysis is discretionary.
The Court also rejected an argument by Galderma that the PMPRB had denied it procedural fairness by deciding the matter on grounds that were not argued by either party.