In a recent decision of the Federal Court, Janssen Inc v The Minister of Health, the Court determined that Health Canada's refusal to list one of Janssen's patents on the Patent Register was reasonable. The Court also dismissed an ultra vires argument brought by Janssen relating to language of the Regulations.

After setting out the procedural history, the Court stated that "The parties agree and I concur that the [refusal to list the patent] is reviewable on a standard of reasonableness." The Court then proceeded to discuss the approach to a reasonableness review as outlined by the SCC in Vavilov.

It appears that the applicable standard of review was not an area of dispute between the parties. However, it is not clear that "reasonableness" is the undisputable conclusion. Notably, this decision appears to have been a missed opportunity for the Federal Court to analyze whether the Supreme Court's "concurrent first instance jurisdiction" category of correctness review applies to patent listing decisions made by Health Canada.

SOCAN v ESA and the Multiple Ways of Challenging Patent Register Eligibility

When Vavilov was released in 2019, it represented a significant shift in how the standard of review framework was approached. In presuming reasonableness review absent certain types of exceptions, judicial review proceedings became more closely focussed on the underlying decision, with less time and debate devoted to the appropriate standard of review to be applied.

However, Vavilov is not the final say on standard of review. In the 2022 decision of SOCAN v ESA, the Supreme Court recognized a further category where the "correctness" standard should apply – concurrent first instance jurisdiction between an administrative body and a Court [26-28].

As set out in SOCAN, where Courts are commonly asked to analyze the same statutory requirements as a first instance court (i.e. not within a judicial review), the legal interpretation should be consistent and "correctness" review should apply. The risk, if reasonableness is applied instead, is inconsistent decisions between administrative decision makers and the Court despite both being tasked with interpreting the same provisions [36-38]. The Court commented that this was likely a rare event, primarily limited to IP statutes [39].

The issue in Janssen, whether the patent listing requirements under the PM(NOC) Regulations were met, is not an issue exclusive to Health Canada. Instead, the "eligibility" of a patent for inclusion on the Patent Register is an issue that can be determined by the Federal Court at first instance, in the context of an action brought under PM(NOC) Regulations:

6.07 (1) In an action brought under subsection 6(1), the Federal Court may, on the motion of the second person, declare that a patent or certificate of supplementary protection is ineligible for inclusion on the register.

(2) The Minister may intervene as of right in the motion and make representations and call evidence that are relevant to any issue in the motion or to the factors that the Federal Court is entitled to take into consideration in determining the issue. The Minister may intervene as of right in any appeal arising from the decision made on the motion, whether the Minister intervened at the Federal Court or not.

While the issue in Janssen was not a dispute over whether the claim met the criterial of subsection 4(2) of the PM(NOC) Regulations, the more common challenge to a patent's eligibility for inclusion on the Patent Register, a challenge under subsection 6.07(1) is not expressly limited to those criteria. At minimum, there appears an argument that a "second person" under the PM(NOC) Regulations can challenge the listing of a patent on any basis, to support that it was "ineligible" for inclusion on the Patent Register.

Where such a challenge is brought, the Federal Court is not tasked with a "review" of the administrator's decision. The PM(NOC) Regulations proceed as a motion within the context of an action, to which the Minister is not a party. In addition, subsection 6.07(2) provides for the Minister's right to intervene in any Patent Register motion, but does not require the Minister to be involved. Had Parliament intended to limit the Federal Court's jurisdiction to a second-instance review, it seems that the Minster's involvement would be mandatory.

Viewed contextually, it appears that Health Canada and the Federal Court have been independently tasked by Parliament with the role of determining the "eligibility" of a patent for inclusion on the Patent Register. If this is indeed the case, they would seem to share jurisdiction and the correctness standard outlined in SOCAN should apply in the context of judicial review.

There may be arguments that mitigate against this approach, or that limit it to only certain "eligibility" decisions. Unfortunately, it does not appear from the brief commentary in Janssen that this was an argument pursued to any degree. With luck, this issue can be more directly canvassed in a future challenge to Patent Register eligibility, with the issue of appropriate standard of review squarely argued.