On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) and the drug JULUCA® (Decision).

The Federal Court determined that the Decision was unreasonable, including for failing to interpret the CSP regime in a manner consistent with the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) as required by the CETA Implementation Act (CIA).  The Decision was remitted back to the Minister for redetermination.

JULUCA: a new combination of medicinal ingredients

JULUCA® is a fixed-dose combination (FDC) drug product containing the medicinal ingredients dolutegravir and rilpivirine (JULUCA).  It is used for the treatment of HIV in adults who are virologically stable and suppressed.

ViiV submitted a CSP application for JULUCA and the 282 Patent.  The 282 Patent contains claims directed to dolutegravir, one of the medicinal ingredients in JULUCA. The 282 Patent is listed on the Patent Register in respect of JULUCA.

The Minister’s Decision

The Minister denied ViiV’s CSP application on the basis that the 282 Patent does not pertain to the combination of medicinal ingredients contained in JULUCA.

The Minister determined that an eligible patent under the CSP Regulations must claim all of the medicinal ingredients contained in a combination drug product.

Federal Court decision: Minister’s Decision is unreasonable

The parties agreed that the applicable standard of review for the Decision is reasonableness pursuant to the Supreme Court’s recent decision in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65.

The Court considered whether the Minister reasonably interpreted paragraphs 106(1)(c) of the Patent Act and 3(2)(a) of the CSP Regulations on patent eligibility in a manner consistent with CETA.

The Court observed that section 3 of the CIA requires that any federal law implementing a provision of, or fulfilling an obligation under, CETA must be interpreted in a manner consistent with CETA. The Court found that the Minister failed to consider the wider context and purpose of the CSP legislative scheme.

The Minister’s Decision was set aside as unreasonable and remitted back to the Minister for redetermination.

Norton Rose Fulbright Canada LLP represented ViiV before the Minister and in this application, which commenced in 2019.

Link to decision: ViiV Healthcare ULC v Canada (Health), 2020 FC 756