Federal Court Of Appeal Agrees That The PMPRB Incorrectly Applied The Patent-Pertaining Analysis

The Federal Court of Appeal has provided new guidance on the proper approach to the "patent pertaining" analysis used by the Patented Medicine Prices Review Board (PMPRB or Board), including on the identification of the medicine and the invention of the patent, in a case concerning Differin®. Having provided this guidance, the Court of Appeal set aside the judgment under appeal and remanded the final determination of whether or not the patent in question pertains to Differin® to the Board.

Background

This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada:

Differin®, which contains 0.1% adapalene. Differin XPTM, which 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 Board Panel did not accept that argument.

Galderma sought judicial review of the Board's decision and, as we reported, Galderma was successful before the Federal Court on the basis that the PMPRB had failed to consider the entirety of the 237 Patent when determining whether it pertained to Differin®.

The PMPRB must consider the whole patent

The first issue before the Court of Appeal was whether the Board acted unreasonably in limiting its review of the 237 Patent to selected portions of the patent.

The Court of Appeal held that the Board must read the patent as a whole — including the claims — in order to identify the invention. However, the Board is not required construe the patent and the claims as a court would. The Board must arrive at a "reasonable" or "sufficient" understanding of the invention, but is entitled to take the patent "at face value" and is not required to arrive at the "correct" interpretation of the patent.

There was only one reasonable interpretation of the invention of the 237 Patent

The second issue before the Court of Appeal required determining the invention of the 237 Patent.

The Court of Appeal held that there was only one reasonable interpretation of the invention in the 237 Patent, and that the Court...