- Parties: The applicant was Janssen Inc. The respondents were the Minister of Health and the Attorney General of Canada.

- Subject Matter: The Office of Submissions and Intellectual Property, acting on behalf of the Minister of Health, determined that Canadian Patent No. 3,113,837 was ineligible for addition to the Patent Register against STELARA® in relation to two supplementary new drug submissions. The applicant filed a judicial review application. One issue was the reasonableness of the decision that a supplemental new drug submission approved for additional safety data that could provide a clinician more confidence in prescribing a drug long-term was not a “change in use of the medicinal ingredient” under s. 4(3) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, if the approved indication never included a temporal restriction on its use.

- Ruling: The court ruled in the respondent’s favour and dismissed the judicial review application. The court held that the applicant failed to show that any aspect of the office’s decision was unreasonable. The court also found the Canadian filing date requirement in s. 4(6) of the regulations ultra vires, illogical, irrational, or arbitrary.

- Date: The hearing was set on May 25, 2023. The court released its decision on July 17, 2023.

- Venue: This was a federal case before the Federal Court.

- Amount: The court ordered the applicant to pay the respondents their costs of the application fixed in the amount of $7,500, inclusive of disbursements and taxes.