Analysis of all Canadian IP Cases

Part 2: Judicial Review

This is our second post analyzing all reported Canadian IP decisions from 2023.

Our earlier post summarized appeals from the Trademarks Office to the Court. This post deals with applications for judicial review to the Federal Court and appeals to the Federal Court of Appeal. 

By way of background, judicial review is a process where a court is asked to review the decision of an administrative tribunal to ensure it was reasonable and fair. The Federal Court has exclusive jurisdiction to review the legality of actions of most federal offices, boards, commissions and tribunals. According to the Federal Courts Act, anyone directly affected by a decision or an order of a federal board, commission or other tribunal may apply to the Federal Court for judicial review within 30 days of the date the decision or order was first communicated to the applicant. 

Overview

In total, there were ten reported decisions in 2023. Five were released by the Federal Court and five by the Federal Court of Appeal.

Judicial review decisions of the Federal Court

Three decisions related to the pharmaceutical industry in matters such as data exclusivity under the Food and Drug Regulations (2023 FC 7), the right of a successor in title to adopt a Notice of Allegation under the Patented Medicines (Notice of Compliance) Regulations (2023 FC 1325), and a decision to deny listing of a patent on the patent register with respect to two supplementary new drug submissions for the biologic STELARA® (2023 FC 870).

The fourth decision addressed whether healthcare practitioners were entitled to an exemption to possess and consume raw psilocybin mushrooms in the course of professional training for psilocybin-assisted psychotherapy under the Controlled Drugs and Substances Act (2023 FC 1283).

The fifth decision concerned an appeal of a decision by the Commissioner of Patents holding that a patent to a partially bio-based polyethylene terephthalate bottle was obvious (2023 FC 424).

In four of the decisions, the application for judicial review was dismissed by the Federal Court with the appellant being ordered to pay costs to respondent. In 2023 FC 424, the Court held the Commissioner erred in construing the inventive concept and the appeal was granted in part, without costs.

The average time to a published decision was 84 days. The quickest decision was released within 14 days of the hearing and the longest within 181 days of the hearing.

Federal Court of Appeal decisions

In total there were five appeals decided.

Two appeals involved decisions of the Minister of Health under the Access to Information Act 2023 FCA 216 and 2023 FCA 249). In one, the appellant was seeking access to information regarding a food supplement licensed under the Natural Health Products Regulations. The other related to a decision by Health Canada to release a redacted audit report. In each case, the Federal Court dismissed the application for judicial review and the Federal Court of Appeal dismissed the appeal from the bench on the same day as the hearing. Costs in each proceeding were awarded to the Minister of Health.

One decision related to the analysis of what is patentable subject matter under the Patent Act (2023 FCA 168). The Commissioner of Patents refused to grant the respondent’s patent application on the ground that the claims were directed to non patentable subject matter and therefore non-compliant with the Patent Act. The respondent successfully overturned the Commissioner’s decision at the Federal Court (2022 FC 923). The Crown appealed and the Federal Court of Appeal allowed the appeal and directed the Commissioner of Patents to redetermine the patentability of the applications “with the benefit of these reasons”. No costs were awarded to either party and the decision took 160 days to be released. 

Two decisions related to pharmaceutical drug approval and regulation under the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations. One (2023 FCA 229) related to Health Canada’s refusal to add the patent list against Janssen’s supplemental new drug submission. The Federal Court dismissed the judicial review and the Federal Court of Appeal dismissed the appeal with costs to Health Canada. The second decision (2023 FCA 3) related to the Minister of Health’s decision to grant a Notice of Compliance under the Food and Drug Regulations to permit Médunik to enter the Canadian market with its RUZURGI® for treating Lambert-Eaton myasthenic syndrome. A third party named Catalyst Pharmaceuticals argued that its own authorised drug FIRDAPSE® was an “innovative drug” under the Regulations entitling it to data protection and Health Canada ought not to have granted authorization to Médunik until the data protection period expired. The Minister of Health rejected Catalyst’s judicial review deciding the data protection regime did not apply. The Federal Court allowed the judicial review; but the Minister appealed and the Federal Court of Appeal allowed the appeal restoring the Minister’s decision.

In terms of timing, three of the five appeals were dismissed from the bench on the day of the hearing. The other two appeal decision were released within 42 days (2023 FC 3) and 160 days (2023 FCA 168).