In a decision released July 7, 2020, the Federal Court granted an application for judicial review of the Minister of Health’s refusal to grant a certificate of supplemental protection (“CSP”) for ViiV’s Juluca product and remitted the matter to the Minister for redetermination.
Juluca is a combination product, comprised of the medicinal ingredients dolutegravir and rilpivirine. ViiV obtained a Notice of Compliance for the product and then applied for a CSP relying on Canadian Patent No. 2,606,282, some of the claims of which are directed to dolutegravir, while none are directed to rilpivirine. The CSP would extend patent protection for a further two years.
The Minister denied the application on the basis that the 282 Patent does not pertain to the combination of the medicinal ingredients dolutegravir and rilpivirine in the manner prescribed in Certificate of Supplementary Protection Regulations (“CSPR”) s 3(2).
The Federal Court, following the Supreme Court’s decision in Vavilov, found that the Minister had failed to act reasonably in coming to this decision as she relied on the Regulatory Impact Analysis Statement (“RIAS”) and a Guidance Document related to the CSPR, and failed to give sufficiently “robust” consideration to ViiV’s submissions regarding the impact of s. 106 of the Patent Act of the provisions of the Canada-European Union Comprehensive Economic and Trade Agreement (“CETA”).
A copy of the ViiV decision may be found here.