On January 5, 2023, the Federal Court of Canada (the Court) in Janssen Inc. v Canada ( Attorney General, 2023 FC 7  found that the Office of Submissions and Intellectual Property (the OSIP) reasonably interpreted Janssen Inc.’s (Janssen) request to reassess the data protection eligibility of Janssen’s nasal spray drug and did not read into the Food and Drug Regulations (the Regulations) a pre-Notice of Compliance (NOC) timing requirement for assessing data protection eligibility.

Janssen sought judicial review of the decision of the Minister of Health dated November 10, 2021, which was communicated by the OSIP.  The Minister found that Janssen’s nasal spray product called SPRAVATO was not an “innovative drug” as defined under subsection C.08.004.1(1) of the Regulations and therefore was not entitled to data protection.

Janssen argued that the Minister’s determinations were “fatally flawed.”  Janssen sought an order setting aside the Minister’s order and granting SPRAVATO data protection under the Regulations, a declaration that SPRAVATO is an “innovative drug”, an injunction preventing the Minister from accepting any new drug submissions from any manufacturer seeking a NOC until the final determination of the judicial review, and costs.

The central issue to be determined by the Court was whether the Minister’s interpretation of the Regulations was reasonable.

The Court first considered whether the Minister erred by holding that SPRAVATO is not an “innovative drug” under subsection C.08.004.1(1) of the Regulations.  Janssen argued that the language of the definition of “innovative drug” in the Regulations must be interpreted consistently with the Canada-United States-Mexico Agreement (CUSMA).  The Court found that the Minister reasonably interpreted the text of the “innovative drug” definition under the Regulations and applied it to SPRAVATO.  The Court noted that the Minister correctly observed that, while the context provided by CUSMA is important, in the end, it is the Regulations as implemented by the Governor in Council that govern, not international agreements.

The Court then considered whether the Minister erred by holding that the relevant time to determine data protection eligibility was at the time SPRAVATO was issued a NOC.  While Janssen argued that the Minister is required to assess data protection each time a generic drug seeks a NOC based on a comparison with an existing approved drug, the Court noted that, under the Regulations, data protection commences on the date a NOC is issued.  The Court stated that the Minister reasonably concluded that it was unnecessary to consider Janssen’s reassessment request and did not read into the Regulations a pre-NOC timing requirement for assessing data protection.

Summary By: Victoria Di Felice


23 01 25

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