Creation of the Certificate of Supplementary Protection
When Canada joined the Canada-European Union Comprehensive Economic and Trade Agreement (known as CETA), it was required to introduce a sui generis regime of “patent-like” protection for pharmaceuticals. To do this, Canada enacted new sections in the Patent Act introducing the Certificate of Supplementary Protection (“CSP”). The CSP is intended to allow eligible patentees to obtain up to two additional years of protection of the medicinal ingredient or combination of medical ingredients listed in a CSP. This allows the patentee to exclude others from “making, constructing, using, and selling any drug that contains the medicinal ingredient or combination of medicinal ingredients set out in the CSP”.
In order to obtain a CSP, the ingredient or combination must be listed in an approved authorization for sale, also known as a Notice of Compliance (“NOC”).
ViiV’s Application for a CSP
ViiV’s JULUCA is a fixed-dosed combination therapy that is comprised of dolutegravir and rilpivirine in a single pill to treat HIV in virologically stable adults. The drug is intended to be an alternative to multi-dose regimes, and is the first approved drug in Canada with this innovative combination. ViiV and Shionogi own a patent with claims that cover dolutegravir, but none of the claims related to rilpivirine.
ViiV applied to the Minister for a CSP covering JULUCA, which was denied on the basis that the patent did not pertain to the combination of the ingredients.
The Minister’s Decision
The Minister refused the CSP on the basis that the patent relating to an approved drug containing a combination of medicinal ingredients had to include a claim for (i) the combination of all those ingredients, (ii) the combination of all the ingredients as obtained by a specific process, or (iii) the use of the combination of ingredients. The Minister also held that CSPs are only available for drugs containing either a new medicinal ingredient or new combination of such ingredients.
In coming to this conclusion, the Minister relied on the Certificate of Supplementary Protection Regulations (CSPR) Regulatory Impact Assessment Statement and associated Guidance Document, referring only in passing to CETA and not considering ViiV’s submissions that CETA supported its interpretation of the Patent Act and CSPR.
ViiV submitted to the Minister that the CSPs are intended to protect single medicinal ingredients or combinations of ingredients contained in new drug “products”, like JULUCA, protected by a “basic patent” (a patent with a claim to at least one medicinal ingredient contained in a combination drug, because it protects the entire product). This argument was consistent with the Patent Act, which provides that a CSP covering a single ingredient will protect a drug including that ingredient in addition to others.
The Court’s Decision
The Federal Court granted ViiV’s judicial review application of the Minister’s decision, holding the Minister had unreasonably dismissed ViiV’s submissions based on CETA by failing to consider CETA itself in addition to the CSPR RIAS and Guidance Document. In reviewing the Minister’s decision, the Court in accordance with the Supreme Court of Canada’s guidance in Vavilov, applied the rebuttable presumption that all administrative decisions are reviewable on the reasonableness standard. To be sustained, the administrative decision must be just, transparent and intelligible, and justified by the factual and legal constraints applicable to the case.
The Court held that the Minister had failed to consider the CSP provisions of the Patent Act in the wider context and purpose of CETA itself, by focussing solely on the CSPR RIAS and Guidance Document. The Court noted that the text of CETA must be consulted to determine the government’s intended scope of protection for the CSP regime, and observed that CETA does not require the protectable drugs be “new” but rather “innovative and creative” products - like JULUCA (as indicated by it receiving an NOC). As a result, the Court remitted the matter to the Minister for redetermination.
When the Minister next considers whether JULUCA satisfies the requirements for a CSP, she must consider CETA itself in addition to the CSPR RIAS and Guidance Document, and specifically provide her analysis in her decision should she wish to argue, for example, that the language used in the Patent Act justifies a narrower reading of the CSP provisions. As no appeal has been filed, this will hopefully occur soon.