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:
- Sections 79 to 103 of the Patent Act;
- the entirety of the regulations and the recent amendments; and
- any PMPRB Compendium of Policies, Guidelines and Procedures published pursuant to Sections 79 to 103 of the Patent Act and the regulations.
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 new mandatory economic factors;
- the changes to the list of the price comparator countries; and
- the new price calculation requirements in Sections 3(4), 4, 6 and the schedule of the amending regulations (collectively, the impugned amendments).
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:
- 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
- an order quashing Sections 3(4), 4, 6 and the schedule of the amending regulations for being ultra vires the Patent Act.
There are a number of key resources relating to the amendments, including as follows:
- The proposed Regulations Amending the Patented Medicines Regulations: 2 December 2017 (published in Part I of the Canada Gazette);
- The dodge report: 23 August 2018 (Independent Assessment of Health Canada's Cost-Benefit Analysis of the Impact of Proposed Amendments to the Patented Medicines Regulations (CG1) by David Dodge and Åke Blomqvist);
- The Working Group to Inform the PMPRB Steering Committee on Modernisation of Price Review Process Guidelines – Final Report: March 2019 (summary of the Working Group's deliberations and recommendations to the Steering Committee on key technical and operational modalities of the draft guidelines);
- Amendments to the Patented Medicines Regulations Cost-Benefit Analysis (CBA): 6 May 2019 (Health Canada's CBA of the amendments to the regulations);
- The PMPRB Steering Committee on Modernisation of Price Review Process Guidelines - Final Report: 2 July 2019 (summary of the deliberations of the Steering Committee in providing stakeholder feedback on the new regime);
- Amendments to the Patented Medicines Regulations – Questions and Answers: 9 August 2019 (PMPRB's answers addressing potential concerns and questions regarding the amendments to the regulations);
- Statement by PMPRB Chairperson on changes to the Patented Medicines Regulations: 9 August 2019;
- Regulations Amending the Patented Medicines Regulations (Additional Factors and Information Reporting Requirements: 21 August 2019) (published in Part II of the Canada Gazette); and
- Unofficial consolidated version of the regulations: 21 August 2019 (consolidated version of the regulations showing the proposed amendments.
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