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18 December 2017
In a November 9 2017 decision, the Federal Court found that the Patented Medicine Prices Review Board's (PMPRB's) assessment that a patent pertained to Galderma Canada's Differin (0.1% adapalene) was unreasonable, as it had failed to consider the entire patent.(1) As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.
Galderma marketed two different adapalene products:
Galderma owned patents that covered Differin, which expired in March 2007 and December 2009. Galderma provided sales and price information to the PMPRB for Differin up until the second patent expired in December 2009.
Galderma also owned Patent 2,478,237 (the '237 patent), covering Differin XP, which expired in March 2016. All of the '237 patent's claims included a 0.3% adapalene limitation. Galderma provided sales and price information for Differin XP until the expiry of the '237 patent in March 2016.
Seven years after the Differin patents had expired, PMPRB staff alleged that Galderma had failed to provide information regarding Differin, citing the '237 patent.
There is a three-part test for determining the PMPRB's jurisdiction:
The key issue before the board was whether part two of the test had been met (ie, whether the invention claimed and described in the '237 patent pertained to Differin). Section 79(2) of the Patent Act provides that "an invention pertains to a medicine if the invention is intended or capable of being used for medicine or for the preparation or production of medicine".
The board concluded that the '237 patent pertained to Differin, noting that "although 0.3% is mentioned in the abstract, it is not mentioned in the introductory paragraph or the title of the 237 patent and the patent does not, on its face, relate exclusively to a 0.3% concentration of adapalene" (for further details please see "Regulatory and judicial round-up"). The board ordered Galderma to provide sales and price information for Differin through to March 2016. Galderma sought judicial review.
Regarding the standard of review, the court held that "the 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)".
The court concluded that the board had misapprehended the question and engaged in an unreasonable analysis. The court found that the board had failed to determine what the invention of the '237 patent was, which was a required step before it could determine whether the invention was intended or capable of being used for the medicine. Instead, the board had incorrectly focused on the commonality of ingredients between Differin XP and Differin and had failed to determine whether the Differin XP medicine was intended or capable of being used for the Differin medicine. According to the evidence, they were two separate medicines. Further, there was no evidence that the former medicine was intended or capable of being used as the latter.
While the court accepted that the analysis of whether a patent pertains to a particular drug does not include a step of claims construction, it noted that the board referenced only the abstract and introductory paragraph and not the claims, description or scope of invention. The board's failure to review the whole patent was found to be unreasonable as, among other things, it was unclear how the board – if it had examined the whole of the '237 patent (particularly its claims) – could have concluded that the patent covered more than 0.3% adapalene.
The attorney general has appealed the decision to the Federal Court of Appeal.
For further information on this topic please contact Urszula Wojtyra at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
(1) Galderma v Attorney General of Canada, 2017 FC 1023.
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