Health Canada instructed to reconsider scope of CSP protection for drug containing multiple active ingredients

On July 10, the Federal Court of Canada released its decision in a judicial review of the Minister of Health’s refusal to grant a Certificate of Supplementary Protection (CSP) to ViiV Healthcare ULC (ViiV) in respect of the drug JULUCA^® and Canadian Patent No. 2,606,282 (282 Patent). The Court held that the Minister’s decision to deny a CSP was unreasonable because the Minister failed to adequately consider the Canada-European Union Comprehensive Economic and Trade Agreement (CETA) in determining whether a patent must contain claims directed to all medicinal ingredients in order to be eligible for a CSP.

What you need to know

• JULUCA^® is a fixed-dose combination therapy in a single pill and contains the medicinal ingredients dolutegravir and rilpivirine. The 282 Patent has claims directed to dolutegravir. None of the claims is directed to rilpivirine.
• The CSP regulations were enacted in order for Canada to meet its obligations with respect to the implementation of CETA into domestic law.
• The CSP regime is relatively new to Canada (promulgated in 2017). A CSP extends certain rights granted by a patent when the patent relates to a drug product, in order to compensate the patent holder for time in the R&D and regulatory approval process.
• Only certain patents are eligible for a CSP. In this decision, the Court suggested that a patent containing claims directed to only one medicinal ingredient may be eligible for a CSP with respect to a drug product that contains a combination of medicinal ingredients.
• The matter has been remitted to the Minister for redetermination.
• If the Minister were to appeal the Court’s decision, the deadline to file the appeal is September 30, 2020 (since, under the Federal Courts Act, July and August do not count in the time for an appeal).
• This is the second judicial review of the refusal of a CSP in Canada (see our bulletin on the first judicial review here—this decision is currently under appeal). In both cases, the Federal Court held that the Minister’s refusal to grant a CSP was unreasonable on the basis that the Minister did not adequately consider CETA in interpreting Canada’s CSP legislation.

Background

ViiV filed an application for a CSP in relation to the drug JULUCA^® and Canadian Patent No 2,606,282. JULUCA^® is the first fixed-dose combination drug approved in Canada containing the medicinal ingredients dolutegravir and rilpivirine. The 282 Patent has claims directed to dolutegravir; however, none of the claims of the 282 Patent is directed to rilpivirine.

The Minister refused to grant a CSP on the basis that the 282 Patent contained claims directed to only one of the medicinal ingredients in JULUCA^®, rather than both medicinal ingredients. In the Minister’s view, Canada’s CSP legislation requires that an eligible patent contain a claim for the combination of all the medicinal ingredients in the drug product. The Minister argued that this interpretation accurately reflected CETA’s requirement that a basic patent protects “a product as such”. In coming to this conclusion, the Minister relied primarily on the Regulatory Impact Analysis Statement (RIAS) for the CSP Regulations and Health Canada’s CSP Guidance Document to help interpret the relevant provisions of the Patent Act and the CSP Regulations.

Analysis

On judicial review, Justice Fuhrer of the Federal Court held that the Minister’s decision was unreasonable on the basis that the Minister failed to give due regard to CETA when interpreting the relevant provisions of the Patent Act and the CSP Regulations, especially since ViiV had raised detailed arguments relating to CETA in its submissions to Health Canada.

In particular, the Court noted that the CETA Implementation Act requires that the CSP legislation be interpreted in a manner consistent with CETA, and as a result the Minister erred by not adequately considering it in its decision. The Court also acknowledged that the RIAS and the associated Guidance Document may be useful tools for determining the intent behind the relevant provisions in the CSP legislation. However, Justice Fuhrer remarked that it was unreasonable for the Minister to refer to CETA only in passing, and to rely on these resources to the exclusion of CETA when considering the proper interpretation of the relevant CSP provisions. The text of CETA must also be consulted to shed light on and to determine the scope of protection applicable to Canada’s CSP regime, Justice Fuhrer remarked.

Justice Fuhrer also commented that CETA seems to “provide a broader scope of protection than the Minister’s interpretation allows”, as it mentions that a drug product must be “innovative and creative” to be eligible for a CSP, rather than “new”. Additionally, the Court remarked that although the 282 Patent only contains claims to one of the two medicinal ingredients, it does protect JULUCA^® “as such”, which is consistent with the requirements under CETA. In other words, the Court suggested that a patent containing claims directed to only one medicinal ingredient may be eligible for a CSP with respect to a drug product that contains a combination of medicinal ingredients. If this interpretation had been applied by the Minister in its decision, the 282 Patent likely would have been eligible for a CSP with respect to JULUCA^®.

What’s next

Ultimately, the Court decided that the submissions made by ViiV with respect to CETA should have been addressed by the Minister in deciding whether to grant a CSP for JULUCA^®. The matter has been ordered to be remitted to the Minister for redetermination. It will be interesting to see whether the Minister appeals the Court’s decision (which must be filed by September 30, 2020). If this decision stands, it would expand the scope of eligible patents for CSP protection. On a broader level, this decision requires the Minister to consider, in addition to the statutory language, the underlying impetus and policy behind new regulations to ensure that Canada is meeting its international obligations with respect to the protection of IP rights domestically.