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14 October 2019
The amendments to the Patented Medicines Regulations, which were published on 21 August 2019 (for further details please see "Canada releases final amendments to patented medicines pricing regulations" and "Countdown begins: getting ready for new patented medicines pricing regime"), have been the subject of two court challenges launched by groups of innovative pharmaceutical companies (22 companies in total) – one in the Quebec Superior Court and the other in the Federal Court.
On 22 August 2019 Merck, Janssen, Servier, Boehringer, Bayer and Theratechnologies (collectively, QC applicants) brought a constitutional challenge to the Patented Medicine Prices Review Board (PMPRB) provisions of the Patent Act and the regulations. The QC applicants argued that the amendments encroach on provincial authority over drug price control and that the federal jurisdiction over patents granted by the Constitution Act 1867 does not permit the federal government to set a maximum sales price for patented goods. They asserted that the intended purpose of Sections 79 to 103 of the Patent Act is to prevent patentees from abusing their statutory monopoly through excessive pricing, while the amendments show that the real nature and objective of these provisions is price control, not patent abuse.
The QC applicants are seeking declarations that the following are ultra vires, invalid and of no force and effect:
On 6 September 2019 Innovative Medicines Canada, AbbVie, Amgen, Astellas, AstraZeneca, Bristol-Myers Squibb, Eli Lilly, Hoffmann-La Roche, Ipsen, Leo Pharma, Lundbeck, Novartis, Novo Nordisk, Otsuka, Pfizer, Sanofi and Takeda (collectively, FC applicants) challenged the validity of the amending regulations relating to:
The FC applicants asserted that the PMPRB has a consumer protection mandate that is limited to protecting consumers from excessive pricing of patented medicines and its jurisdiction is limited to factory-gate pricing. They argued that the impugned amendments impermissibly expand the PMPRB's statutory mandate and jurisdiction, which the governor in council has no authority to do by way of regulation. Further, the FC applicants argued that the impugned amendments are ultra vires in that their purpose is inconsistent with the Patent Act's purpose and that each of the impugned amendments exceed the regulation-making authority conferred by the Patent Act and is inconsistent with it.
The FC applicants are seeking:
There are a number of key resources relating to the amendments, including as follows:
For further information on this topic please contact Eleanor Wilson or Nancy Pei at Smart & Biggar's Toronto office by telephone (+1 416 593 5514) or email (firstname.lastname@example.org or email@example.com). Alternatively, please contact Daphne Lainson at Smart & Biggar's Ottawa office by telephone (+1 613 232 2486) or email (firstname.lastname@example.org). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
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