Decision

Janssen Inc. v. Canada (Health), 2023 FC 870

Justice Aylen - 2023-07-17

Read full decision. Automatically generated summary:

The Applicant, Janssen, seeks judicial review of a decision of the Office of Submissions and Intellectual Property [OSIP] on behalf of the Minister of Health. OSIP determined that the 837 Patent was not eligible to be added to the Patent Register against STELARA® with respect to two supplementary new drug submissions. ... of central importance are the following two issues: (i) whether OSIP’s 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 is not a “change in use of the medicinal ingredient” as prescribed by subsection 4(3) of the PMNOC Regulations if the approved indication never included a temporal restriction on its use was reasonable; and (ii) whether the Canadian patent filing date requirement in subsection 4(6) of the PMNOC Regulations is ultra vires the Patent Act. For the reasons that follow, I am not satisfied that Janssen has demonstrated that there is any basis for the Court’s intervention. Accordingly, the application for judicial review shall be dismissed in its entirety, with costs.

Decision relates to:

 

Canadian Intellectual Property