On May 7, 2020, the Patented Medicines Prices Review Board (PMPRB or Board) ordered Galderma to file prescribed sales and financial information for DIFFERIN (0.1% adapalene) until the expiry of the 237 patent (2,478,237), which claims compositions containing 0.3% adapalene. The Board's decision is the redetermination that was ordered by the Federal Court of Appeal (FCA) in June 2019 (previously reported here) on the threshold jurisdictional question of whether the 237 patent pertains to DIFFERIN.
Galderma has marketed two different adapalene products: DIFFERIN (0.1% adapalene) and DIFFERIN XP (0.3% adapalene). The FCA determined that the invention of the 237 patent was the use of a 0.3% concentration of adapalene for the treatment of dermatological disorders, and remitted to the Board the question of whether the invention of the 237 patent pertained to DIFFERIN (see our article here regarding the FCA decision and further relevant background). The FCA directed that to determine whether the invention of the 237 patent pertained to DIFFERIN, the question is whether the invention of the 237 patent is intended or capable of being used for DIFFERIN.
The Board's decision
The Board considered the evidence of clinical similarities and differences between DIFFERIN and DIFFERIN XP and took into account what it considered to be the relevant policy considerations.
The Board held that its consumer protection mandate required it to ensure that the statutory monopoly granted to patentees of medicines is not abused by excessive pricing of those medicines. The Board Staff had also submitted that the Board had an obligation to "ensure that patentees should not be able to evade the Board's regulatory oversight by marketing a core drug product through various line extensions."
The Board disagreed with Galderma's assertions that in order for an invention to pertain to a medicine, the invention must "encompass" the medicine that a patentee is selling in Canada. Relying on the wording of the statute and FCA decisions, including the underlying decision, the Board held that "encompassing a medicine" is a "more restrictive expression" than intended by the statute.
Based on the evidence before it, the Board concluded that the "collective effect of [the] clinical similarities between differin and the invention of the 237 patent as reflected in Differin XP establish that the invention of the 237 patent is intended or capable of being used for Differin." The Board pointed to the following similarities:
- the two medicines are two different concentrations of a single active ingredient, adapalene, for the same indication, which employs an identical mechanism of action in both medicines;
- both medicines are the subject of a single product monograph;
- the adverse reactions for both medicines are of the same type and of similar average intensity with similar timing of onset and similar rates of occurrence; and
- no topical acne products are considered unsubstitutable, and clinicians view both medicines as appropriate treatment for certain forms of acne.
The Board therefore required Galderma to file sales and financial information for DIFFERIN until the expiry of the 237 patent in 2016.
Galderma can apply to the Federal Court for a judicial review of the Board's redetermination decision.
Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation group.
Originally published July 15, 2020.
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