On 28 June 2019 the Federal Court of Appeal granted the Patented Medicine Prices Review Board's (PMPRB's) appeal and returned to the PMPRB the matter of whether the invention of the 2,478,237 patent (the '237 patent) – which the Federal Court of Appeal found was the use of a 0.3% concentration of adapalene for the treatment of dermatological disorders – pertained to Galderma's Differin (0.1% adapalene).(1) In determining whether an invention pertains to the medicine, the court held that the phrases 'rational connection or nexus' or 'merest slender thread' cannot supplant the statutory language, which requires that "the invention is intended or capable of being used for the medicine".
Galderma marketed two different adapalene products:
- Differin containing 0.1% adapalene; and
- Differin XP containing 0.3% adapalene.
Galderma had patents that covered Differin, which expired in March 2007 and December 2009. Galderma provided sales and price information to the PMPRB for Differin until the second patent expired in December 2009.
Galderma also had a patent that covered Differin XP (the '237 patent), which expired in March 2016. All claims of the '237 patent included a 0.3% adapalene limitation. Galderma provided sales and price information for Differin XP until the '237 patent expired in March 2016.
Seven years after the Differin patents expired, PMPRB officials alleged that Galderma had failed to provide information regarding Differin, pointing to the '237 patent.(2) The PMPRB 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".
The PMPRB ordered Galderma to provide sales and price information for Differin through to March 2016.
Galderma applied for judicial review of the PMPRB's decision. The Federal Court quashed the PMPRB's decision as the failure to review the whole patent was found to be unreasonable, including because it was unclear how the PMPRB – had it examined the whole of the '237 patent (particularly its claims) – could have concluded that the patent covered more than 0.3% adapalene (for further details please see "Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine").
On appeal, the Federal Court of Appeal addressed the following issues:
- Did the PMPRB act unreasonably in limiting its review of the '237 patent to selected portions of the patent?
- What was the invention of the '237 patent?
- Did the invention of the '237 patent pertain to Differin?
The Court of Appeal held that the PMPRB was entitled to deference and therefore the PMPRB's decision should be reviewed on a reasonableness standard.
PMPRB acted unreasonably The Federal Court of Appeal found that the PMPRB was unreasonable as it had reviewed only selected portions of the patent (the abstract and an introductory paragraph) and therefore ignored critical parts of the patent, including the claims. The Federal Court of Appeal held that the PMPRB should look at the patent as a whole to gain a sufficient understanding of the invention, but should not have to construe the patent or claims as a court would. The PMPRB is not required to go "beyond the face of the patent" to find implied limitations or additions to the words used by the patentee.
Invention was use of 0.3% adapalene The Federal Court of Appeal held that there was only one reasonable interpretation of the words of the '237 patent regarding the nature of the invention and, as such, the court was entitled to supply the interpretation without referring the matter back to the PMPRB.
Based on a review of the whole patent, and considering that there was no claim for a pharmaceutical composition having an adapalene concentration of less than 0.3%, the court concluded that the invention of the '237 patent was a pharmaceutical composition having a concentration of 0.3% adapalene to be used in the treatment of dermatological conditions with an inflammatory or proliferative component, such as common acne.
Whether invention of '237 patent pertains to Differin remitted to PMPRB Ultimately, the Federal Court of Appeal returned to the PMPRB the question of whether the invention of the '237 patent pertained to the medicine. In doing so, the court commented on what the 'medicine' was in this case and the meaning of 'pertains to a medicine'.
As an initial question, the court found that the PMPRB had reasonably held that the medicine was Differin, as opposed to adapalene. The court reasoned that the "medicine in question would necessarily have to be the medicine which was sold in Canada at the material time, otherwise the question of excessive price would not arise".
With respect to the meaning of 'pertains to a medicine', the court explained that Section 79(2) of the Patent Act stipulates 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 previous 'merest slender thread' interpretation was described as a helpful metaphor, but the court emphasised that a metaphor cannot supplant the statutory definition: "The question is whether the invention is intended or capable of being used for medicine, and not whether there is the merest slender thread of a connection."
The court held that the PMPRB's decision was unreasonable if it rested solely on the premise that the '237 patent did not relate exclusively to 0.3% adapalene and that there was a possibility that it also related to 0.1% adapalene so that, in those circumstances, the invention of the '237 patent could be used for Differin, as well as for Differin XP. This premise was incorrect given the court's finding that there was only one reasonable interpretation of the '237 patent, as explained above.
However, the Federal Court of Appeal noted that the PMPRB had pointed to other factors in its decision, including that both Differin and Differin XP contained adapalene and were used for the same purpose. Therefore, the PMPRB should be allowed to address "what kind of clinical similarities would support a finding that the invention of a patent was intended or capable of being used for that medicine", particularly in cases such as this, where the question is whether an invention pertains to a specific medicine.
Therefore, the Federal Court of Appeal granted the PMPRB's appeal and remitted the matter to the board for redetermination having regard to the court's holding as to the invention of the '237 patent. If Galderma wishes to appeal, it must obtain leave from the Supreme Court of Canada.
(1) Attorney General of Canada v Galderma, 2019 FCA 196.
(2) More information on Galderma's Differin is available here.
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