On June 28, 2019, the Federal Court of Appeal granted the appeal of the Patented Medicine Prices Review Board (PMPRB or Board) and returned to the Board the matter of whether the invention of the 237 patent – which the 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): Attorney General of Canada v Galderma, 2019 FCA 196. 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 has 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 (Patent No. 2,478,237 or 237 patent), which expired in March 2016. All claims of the 237 patent include a 0.3% adapalene limitation. Galderma provided sales and price information for DIFFERIN XP until expiry of the 237 patent in March 2016.
Seven years after the DIFFERIN patents expired, PMPRB staff alleged that Galderma had failed to provide information regarding DIFFERIN, pointing to the 237 patent. As previously reported, the Board concluded that the 237 patent pertained to DIFFERIN, noting “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 Board ordered Galderma to provide sales and price information for DIFFERIN through to March 2016.
Galderma applied for judicial review of the Board’s decision. As reported previously, the Federal Court quashed the Board’s decision as the failure to review the whole patent was found to be unreasonable, including as 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 Court of Appeal decision
On appeal, the Court of Appeal addressed the following issues:
A. Did the Board act unreasonably in limiting its review of the 237 patent to selected portions of the patent?
B. What is the invention of the 237 patent?
C. Does the invention of the 237 patent pertain to DIFFERIN?
The Court of Appeal held that the Board was entitled to deference, and therefore the Board’s decision should be reviewed on a reasonableness standard.
A. The Board acted unreasonably in limiting its review of the patent to selected portions
The Court of Appeal found that the Board was unreasonable as it had only reviewed selected portions of the patent (the abstract and an introductory paragraph) and therefore ignored critical parts of the patent, including the claims. The Court of Appeal held that the Board 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 Board is not required to go “beyond the face of the patent” to find implied limitations or additions to the words used by the patentee.
B. The invention of the patent is the use of 0.3% adapalene for the treatment of dermatological disorders
The Court of Appeal held that there was only one reasonable interpretation of the words of the 237 patent as to the nature of the invention, and as such, the Court is entitled to supply the interpretation without referring the matter back to the Board.
Based on a review of the whole patent, and taking into account 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 is 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.
C. Whether the invention of the 237 patent pertains to DIFFERIN remitted to the Board
Ultimately, the Court of Appeal returned to the Board the question of whether the invention of the 237 patent pertains to the medicine. In doing so, the Court commented on what was the ‘medicine’ in this case and the meaning of ‘pertains to a medicine’.
As an initial question, the Court found that the Board 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 subsection 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 emphasized 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 Board’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 Court of Appeal noted that the Board 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 Board 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.
The Court of Appeal therefore granted the Board’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 will have to obtain leave from the Supreme Court of Canada.