PMPRB Update: PMPRB Is Accepting Intervener Leave Applications For SOLIRIS Re-hearing

On April 1, 2022, Canada's Patented Medicine Prices Review Board ("PMPRB") announced it will hold a public re-hearing concerning the price of Alexion Pharmaceuticals' patented medicine SOLIRIS (eculizumab). The Board further announced that it will be accepting intervener applications until May 1, 2022.¹

As previously reported, Alexion markets the medicine SOLIRIS, a breakthrough treatment for two rare and life-threatening blood-related disorders. In 2017, the PMPRB issued a decision finding that Alexion sold SOLIRIS at an excessive price contrary to the Patent Act, and ordered Alexion to forfeit excess revenues earned between 2009 and 2017.² The Board relied on the fact that the Canadian list price of SOLIRIS was higher than the price in one of seven comparator countries specified in the Patented Medicines Regulations. According to the PMPRB, the price of SOLIRIS had to be lower than that of all seven comparator countries to avoid being excessive, departing from the provisions of the PMPRB Guidelines.

Alexion applied for judicial review to the Federal Court of Canada. The Court dismissed Alexion's application, finding that the PMPRB's decision was reasonable because it was entitled to significant deference.³  Alexion appealed to the Federal Court of Appeal. The Federal Court of Appeal quashed the lower court's decision, sending a strong signal that general price control and consumer protection is not within the PMPRB's jurisdiction, and are not part of the balance struck in the Patent Act between incentivizing research and development of patented medicines in Canada and protecting against patent abuse.⁴ Ultimately, the FCA remitted the matter back to the PMPRB for re-determination.

Footnotes

1. https://www.canada.ca/en/patented-medicine-prices-review/news/2022/04/patented-medicine-prices-review-board-imposes-deadline-for-motions-for-leave-to-intervene-in-the-redetermination-of-board-decisions-regarding-the-e.html

2. https://www.pmprb-cepmb.gc.ca/CMFiles/Hearings%20and%20Decisions/Decisions%20and%20Orders/Panel_s_Decision_-_Excess_Revenue_Payment.pdf

3. Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2019 FC 734

4. Alexion Pharmaceuticals Inc. v. Canada (Attorney General), 2021 FCA 157

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