Strike 2: Health Canada's narrow interpretation of the CSP Regulations rejected once again

22 July 2020

In April, the Federal Court issued its first decision interpreting the Certificate of Supplementary Protection Regulations (the "CSP Regulations") in GlaxoSmithKline biologicals SA v Canada (Health), 2020 FC 397, where Justice Barnes stressed the importance of an interpretation that was consistent with the purpose and intent of the Canadian European Trade Agreement ("CETA"). See our earlier article on that decision here.

The Federal Court has now issued its second decision interpreting the CSP Regulations, in ViiV v Minister of Health, 2020 FC 756, a decision of Justice Fuhrer, once again highlighting the importance of interpreting the CSP Regulations purposively and harmoniously with Canada's international obligations, and the goal of rewarding the rapid introduction of innovative and creative products into Canada. 



Background

At issue before the Court was a CSP application in relation to ViiV's product JULUCA. JULUCA is a combination therapy for the treatment of HIV, containing two medicinal ingredients: dolutegravir and rilpivirine. JULUCA was the first approval of this innovative combination in a fixed-dose combination drug in Canada. Upon JULUCA's approval, ViiV listed Canadian Patent 2,606,282 (the "282 Patent") on the Patent Register. Notably, while several claims of the 282 Patent are directed to dolutegravir, none of them claimed dolutegravir and rilpivirine in combination.

ViiV also applied for a CSP for JULUCA in relation to the 282 Patent, however the Minister of Health (the "Minister") advised that it was not eligible in light of the fact that the 282 Patent did not "pertain to" the combination of the medicinal ingredients dolutegravir and rilpivirine. The Minister's position was that a patent must claim "the combination of all of the medicinal ingredients" in the product to meet the criteria of s.3(2)(a) of the CSP Regulations. In coming to this decision, the Minister relied only on the CSP Regulations Regulatory Impact Analysis Statement ("RIAS") and associated Guidance Document.

ViiV commenced an application for judicial review of the Minister's decision on several grounds, including that the Minister's interpretation of the CSP Regulations was contrary to the purpose and intent of CETA.  

Positions of the Parties

ViiV took the position that in implementing CETA, and specifically the IP provisions within article 20.27, Canada's sui generis regime is intended to provide protection for single medicinal ingredients or combinations of medical ingredients in new products protected by "basic patents" (as defined in the text of CETA, Article 20.27). Under Viiv's interpretation, this includes patents claiming a single medicinal ingredient in a combination product, given the fact that the entire product is nonetheless protected. ViiV submitted that this interpretation recognized the benefits of combination products, and provided the balance of sui generis rights in exchange for bringing innovative and creative products to Canada. To exclude patents claiming only one part of the combination would improperly narrow the scope of the CSP Regulations, and push innovators towards offering only single compound products, despite the patient benefits of fixed-dose combination products.

The Minister, in contrast, argued that the CSP Regulations were intended to be more narrowly interpreted than CETA, relying on the text of CETA which permits signatories to "determine the appropriate method of implementing the provisions of CETA". Relying largely upon the RIAS, the Minister noted that Canada proscribed a limited protection to the "product as such." In the Minister's view, where a combination product was approved, the claim must pertain to all medicinal ingredients within the product. With respect to the bargain between sui generis rights and innovative products, the Minister took a stringent position that those rights are only available where the technical requirements of the CSP Regulations are met.

The Court's Analysis

The Court framed the determinative issue before it as follows: did the Minister reasonably interpret the Patent Act and the CSP Regulations in a manner consistent with CETA (as required by the CETA Implementation Act, s.3) by relying only on the RIAS and Guidance Document? As part of its review, the Court agreed with the parties that the issues was to be determined on the standard of reasonableness, in light of the recent SCC decision in Vavilov (see our article on that decision here).

The Court noted at the outset that while the RIAS may be useful in interpreting the CSP Regulations, it was not alone determinative and could not be the sole source for the Minister's interpretation. Further, the Court noted instances in the RIAS which seemed to "read in" limits or other conditions that were not found in the Patent Act or CSP Regulations themselves.

The Court disagreed with the Minister's view that Canada intended for a narrower scope of protection than was otherwise set out in CETA, and was permitted to do so in light of the enabling provisions of CETA, noting a lack of evidence that Canada ever intended on implementing a more limited approach than what was plainly set out in the text of CETA:

[A] provision permitting signatories to implement given schemes in accordance with their own rules does not in itself absolve decision makers from adequately explaining that a more limited domestic interpretation was intended. There is nothing on the record in this matter to suggest Canada intended a more limited approach than what was contemplated in CETA, or always had interpreted CETA in a more limited way than the alternative suggested by ViiV.

Because the RIAS and Guidance Document do not consider CETA, the Court found the focus must turn to what the legislator actually did, taking into account the presumption that the domestic legislation conforms with international law. Ultimately, the Court found that by failing to consider anything other than the RIAS, the Minister failed to consider ViiV's submissions on a harmonious reading of s.3(2)(a) of the CSP Regulations with CETA. The failure to consider these relevant submissions made the Minister's decision unreasonable, and the Court remitted it to the Minster for reconsideration.

Focus for Future CSP Submissions

The first two decisions regarding interpretation of the CSP Regulations strongly support a harmonious reading of the CSP Regulations in light of the international obligations Canada was entering into in light of CETA. The CSP Regulations mimic the Supplementary Protection Certificate regime in the EU, and therefore they should not be read-down or limited on technicalities that do not align with the overall purpose and intent of this new sui generis protection.

While the underlying rejections for both JULUCA and SHINGRIX were issued before the Court's guidance on the CSP Regulations' interpretation, it remains to be seen if a different approach will be adopted by Health Canada. With these two decisions, the Court has provided strong guidance for submissions recognizing the balance between this sui generis protection, and the introduction of novel and innovative medicines into Canada. In the event patentees face preliminary rejections from Health Canada, submissions focussed on the policy and intent of the CSP Regulations, along with Canada's intentions underlying CETA, should be a strong focus.


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