Federal Court Releases Decision On Validity Of The Amending Regulations Of The Patented Medicines Regulations
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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
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.
Originally published by Smart & Biggar, June
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