ViiV Healthcare ULC v. Canada (Health), 2020 FC 756 (Dolutegravir*)

Justice Fuhrer - 2020-07-10

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To implement the sui generis regime of additional “patent-like” protection for pharmaceuticals described in CETA Article 20.27, Canada introduced the Certificate of Supplementary Protection or CSP in new sections 104-134 to the Patent Act, RSC 1985, c P-4. ... Was the Minister’s refusal to issue a CSP for JULUCA reasonable? This involves the more granular question: was Minister’s interpretation of Patent Act s 106(1)(c) and CSPR s 3(2)(a), namely that an eligible patent must claim all the medicinal ingredients in a combination drug to support the issuance of a CSP, consistent with the text, context and purpose of these provisions? ... These reasons therefore deal only with the appropriate standard of review and whether the Minister reasonably interpreted Patent Act s 106(1)(c) and CSPR s 3(2)(a) in a manner consistent with CETA, as required by CIA s 3, by relying only on the CSPR Regulatory Impact Assessment Statement (“RIAS”) and associated Guidance Document. For the reasons that follow, I grant this judicial review application because the Minister unreasonably considered ViiV’s submissions based on CETA Article 20.27 regarding the proper interpretation of Patent Act s 106(1)(c) and CSPR s 3(2)(a), by failing to consider CETA itself in addition to the CSPR RIAS and Guidance Document. This matter will be remitted to the Minister for redetermination.

Decision relates to:



Canadian Intellectual Property