Strike three: Federal Court finds that Health Canada failed to consider context and purpose of the CSP regime

4 minute read
20 October 2021

The Federal Court has called its third strike on Health Canada regarding its interpretation of the Certificate of Supplementary Protection Regulations[1] (CSP Regulations).

In this latest decision concerning a judicial review brought by Merck Canada Inc. ("Merck") against the Minister of Health, the Court held that Health Canada failed to consider the context and purpose of the CSP regime, as set out in the Patent Act and CSP Regulations, in denying Merck's CSP application for Canadian Patent No 2,670,892 in relation to BELSOMRA.

In its decision, the Federal Court highlighted the need to provide a full and purposive interpretation of the CSP Regulations using not only its statutory language, but equally its purpose in implementing Canada's Canadian-European Trade Agreement (CETA) obligations. This broader context was highlighted by the Federal Court as "a pertinent aspect of [the CSP Regulations'] interpretation" that must be taken into account.[2]

And once again, the Federal Court criticized Health Canada for failing to provide any analysis of this central issue. In the words of the Federal Court, the failure to address the purpose of the CSP Regulations in the broader context of CETA, an issue squarely raised by Merck in its submissions as to the CSP eligibility, caused the Federal Court to "lose confidence in the Minister's decision," and rendered the Minister's decision unreasonable.[3] As a result, the matter was sent back to the Minister for redetermination.

This decision emphasizes the changing landscape to administrative review in a post-Vavilov world. Following Vavilov, the Federal Court is no longer willing to "fill in the blanks" where the administrative decision maker's reasons do not meaningfully address the key issues or arguments raised. Instead, the decision maker must establish in its reasons that the proper analysis was undertaken.  

The takeaway is clear – interpretation of the CSP Regulations requires an analysis of the broader context of CETA, including an analysis of the object and purpose of the CSP Regulations. Further, rather than only looking at the mere language of the CSP Regulations, the statutory language must be considered along with the broader legislative purpose.

Should you have any specific questions about this article or would like to discuss it further, you can contact the authors or a member of our Life Sciences Group.

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