On June 29, 2020, the Federal Court of Canada (the Court) issued its decision in Innovative Medicines Canada v Canada (Attorney General), 2020 FC 725, challenging the validity of certain provisions of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) SOR/2019-298 (the Amendments) set to come into force on January 1, 2021. The Amendments provide the Patented Medicine Prices Review Board (the PMPRB) with new regulatory tools and information reporting authority to regulate the prices that patentees charge for patented medicines and protect Canadian consumers from excessive pricing.
The applicants, Innovative Medicines Canada and several Canadian innovative pharmaceutical companies, brought a judicial review application challenging the following provisions:
The Court applied a reasonableness standard of review in considering the exercise of the Governor in Council’s regulation-making authority under the Patent Act. The Court found that the new price calculation contemplated in subsection 3(4) is invalid, void and of no force and effect as it is ultra vires the Patent Act. Accordingly, the existing price calculation will continue to apply such that patentees are only required to report information on price adjustments for the first point of sale. The remaining two sections of the Amendments were found to be reasonable and valid.
Summary By: Anna Troshchynsky
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