Product-Specificity Strikes Back: Minister Of Health Rejects CSP Application

Recently, ViiV Healthcare ULC brought one of the the first applications for judicial review from a decision of the federal Minister of Health (the "Minister") to deny a certificate of supplementary protection ("CSP").1

The Minister held that ViiV's drug JULUCA was ineligible for a CSP because the basic patent at issue claimed only one of its two medicinal ingredients.

The Minister's decision and the Federal Court proceeding may have a significant impact on future CSP applications.

Background: the CSP Regime Extends Patent Protection for Qualifying Drugs

Unlike most products, pharmaceuticals require marketing authorization before they can be sold. Seeking government approval often consumes much of the term of any patents protecting a drug, leaving little time to exploit the hard-earned patent.

In 2015, drug patent term extensions were negotiated between Canada and the European Union as part of the Canada-European Union Comprehensive Economic and Trade Agreement ("CETA"). As a part of the CETA negotiations, Canada agreed to restore, in part, the term of patent rights covering medicinal ingredients contained in drugs that are delayed to market due to pending Health Canada safety and efficacy reviews.

Canada ratified the CETA patent term extension obligation by enacting the CSP regime, which is encoded in the Patent Act and the Certificate of Supplementary Protection Regulations (the "CSP Regime").2 Under the CSP Regime, a patentee may apply to the Minister for a CSP. The Minister will then assesses whether to issue a CSP based on the eligibility criteria set forth in the CSP Regime. If granted, a CSP extends the term of a patent covering medicinal ingredients (with respect to making, constructing, using, and selling the qualifying drug) by up to two additional years.

Among other things, to be eligible for a CSP, one criterion is that the patent forming the basis for the CSP application (a "basic patent") must "pertain to a medicinal ingredient, or combination of medicinal ingredients, contained in a drug for which an authorization for sale...was issued".3

Under the CSP Regime, a patent pertains to a medicinal ingredient or combination if it "contains a claim for the medicinal ingredient or combination of all the medicinal ingredients contained in a drug".4

The Minister's Decision in JULUCA Revives Product-Specificity Reasoning

ViiV applied for a CSP extending the term of Canadian Patent No. 2,606,282 (the "282 Patent"). The 282 Patent claimed...