July 21, 2020
The Patented Medicines Prices Review Board (“PMPRB”) has released its decision on redetermination with respect to whether the invention of Canadian Letters Patent No. 2,478,237 (the “237 Patent”) pertains to the medicine Differin.
Despite clear guidance from the Federal Court of Appeal that at least part of the invention of the 237 Patent is "a concentration of 0.3% adapalene", the PMPRB determined that the invention nevertheless pertains to Differin, a product which contains an entirely different concentration of adapalene (0.1%).
On December 19, 2016, the PMPRB ordered Galderma Canada Inc. (“Galderma”) to file sales and financial information with respect to its product Differin for the period between January 1, 2010 and March 14, 2016. This decision was set aside by the Federal Court and later appealed to the Federal Court of Appeal. The Federal Court of Appeal returned this matter to the PMPRB for redetermination.
In what was viewed as a landmark decision, the Federal Court of Appeal settled that “pertains to medicine” ought to be interpreted using the ordinary meaning of subsection 79(2) of the Patent Act (which reads "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 Federal Court of Appeal further determined 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”, and that the “medicine” in question was Differin, not adapalene.
A summary of the Federal Court of Appeal’s decision was published by the GoodmansIP team on July 10, 2019.
B. The Redetermination Decision
The sole issue for the PMPRB was whether the 237 Patent pertained to the medicine in question, Differin.
i. The Parties’ Submissions
The PMPRB Staff’s position was that the invention of the 237 Patent does pertain to Differin, and that, despite the different adapalene concentrations in the invention of the 237 Patent and Differin, both the invention of the 237 Patent and Differin use the same molecule and same mechanism of action to treat the same condition, with similar clinical efficacy and side effects. Accordingly, the invention of the 237 Patent is intended or capable of being used for Differin.
Galderma’s position was that the invention of the 237 Patent does not pertain to Differin, because there are clinical differences between the invention of the 237 Patent and Differin. The invention of the 237 Patent (the use of 0.3% adapalene) cannot be used for Differin (which uses 0.1% adapalene). In Galderma’s view, the different concentrations of adapalene (0.1% vs 0.3%) result in differences in effectiveness, tolerance and side effects and are treated as distinct and different medicines in the 237 Patent, the product monograph and by prescribing clinicians.
The PMPRB noted that there was no dispute that the 237 Patent pertains to the medicine Differin XP (which uses a 0.3% concentration of adapalene to treat dermatological disorders). Despite this consensus, the PMPRB considered it appropriate to assess the similarities and differences between Differin XP (0.3%) and Differin (0.1%) in determining what kinds of clinical similarities would support the conclusion that the invention of the 237 Patent (which relates at least in part to a concentration of 0.3%) somehow pertains to Differin (which has a concentration of 0.1%).
The PMPRB found that the collective effect of the “clinical similarities between Differin and the invention of the 237 Patent as reflected in Differin XP [emphasis added] establish that the invention of the 237 Patent is intended or capable of being used for Differin”. The clinical similarities were summarized by the PMPRB below:
Differin and Differin XP are two different strengths or concentrations of the same single active therapeutic ingredient, they have the same indication and employ an identical mechanism of action. The difference in strength or concentration does not affect either the chemical structure or mechanism of action of the active therapeutic ingredient;
There is a single product monograph for Differin and Differin XP, which identifies, among other things, contraindications, warnings and precautions, types of potential adverse reactions and dosage, administration, storage and stability guidelines, which are common to both;
The adverse reactions for both Differin and Differin XP are of the same type and of average intensity, both products are well tolerated and the occurrence of undesirable side effects is statistically the same for the 0.1% adapalene and 0.3% adapalene gels; and
Clinicians view both Differin and Differin XP as appropriate treatment for certain forms of acne and the different concentrations of adapalene in Differin and Differin XP allow the clinician to tailor the medication to individual skin types to obtain optimal combination of efficacy and tolerance.
Having established the invention of the 237 Patent pertains to Differin, the PMPRB ordered Galderma to file the prescribed sales and financial information for Differin for the period between January 1, 2010 and March 14, 2016.
C. Going Forward
Galderma has the opportunity to seek a judicial review of the PMPRB's decision in the Federal Court.
The Federal Court of Appeal's prior decision was expected to bring some level of certainty and predictability into the assessment of whether the invention of a particular patent pertains to a particular medicine. Given the PMPRB's decision on redetermination, it would appear that the hoped-for certainty and predictability was short-lived or non-existent and that further guidance will be required by the Federal Court (and likely the Federal Court of Appeal).
In the meantime, participants in the Canadian pharmaceutical marketplace will need to be:
mindful that the PMPRB could assert jurisdiction over a given medicine on the basis of a patent that clearly does not encompass the medicine, provided that there are sufficient clinical similarities between the claimed medicine and the medicine at issue; and
ready and willing to challenge the PMPRB's jurisdiction over a medicine by way of judicial review.