Federal Court releases decision on validity of the Amending Regulations of the Patented Medicines Regulations

Smart & Biggar

On June 29, 2020 the Federal Court released its decision in Innovative Medicines Canada et al. v The Attorney General of Canada et al, 2020 FC 725.

This judicial review challenged the validity of the Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements) (discussed here), which were published on August 21, 2019.

The Applicants sought:

(i) A declaration that sections 3(4), 4, 6 and the Schedule of the amending Regulations are invalid, void and of no force and effect as ultra vires the Patent Act; and

(ii) An order quashing sections 3(4), 4, 6 and the Schedule of the amending Regulations as ultra vires the Patent Act.

Section 3(4) expanded the reporting requirements for price and revenue information to take into account, inter alia, discounts and rebates provided to third parties. Section 4 created new price regulatory factors: pharmacoeconomic value, market size and Gross Domestic Product (GDP) factors. Section 6 amended the basket of reference countries creating the new PMPRB 11.

The Court found Subsection 3(4) invalid, void and of no force and effect and ultra vires the Patent Act. The remaining amendments were found valid.

It is unclear how the decision will impact on the current Guidelines consultation (see here) for which comments are due by July 20, 2020.

The parties will have 30 days to appeal.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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