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Federal Court concludes Minister of Health’s decision not to reassess data protection for SPRAVATO in view of CUSMA is reasonable

Authored byBrandon Heard

Before approving Janssen’s esketamine hydrochloride product (SPRAVATO) on May 20, 2020, the Minister of Health determined that it was not an “innovative drug” as defined by section C.08.004.1(1) of the Food and Drug Regulations (Regulations) and therefore not entitled to data protection. Janssen’s application for judicial review was dismissed, and the decision was upheld by the Court of Appeal.

Following the implementation of the Canada-United States-Mexico Agreement (CUSMA) on July 1, 2020, Janssen requested that the Minister reassess whether SPRAVATO was an innovative drug. The Minister rejected the request and Janssen filed a further application for judicial review. On January 5, 2023, Justice Manson found that the Minister’s decision was reasonable and dismissed Janssen’s application: Janssen Inc v Canada (Attorney General), 2023 FC 7.

The Minister’s decision

The Minister refused to reassess data protection for SPRAVATO because eligibility is determined “at the time the first notice of compliance [NOC] is issued.” In any event, the Minister found that SPRAVATO still did not meet the definition for innovative drug following the implementation of CUSMA.

New evidence was improper

As a preliminary matter, the Court disregarded three new affidavits that were not available to the Minister. The evidence addressed the decision-making processes of foreign regulators for SPRAVATO and did not satisfy any exception to the rule that the Court is bound to the same record as the decision maker below.

Minister’s decision that SPRAVATO is not an “innovative drug” was reasonable

As defined by subsection C.08.004.1(1) of the Regulations, “innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a[n] … enantiomer …”.

There was no dispute that esketamine hydrochloride is an enantiomer of ketamine hydrochloride, which is a medicinal ingredient in drugs previously approved by the Minister.

Janssen argued that the Minister was required to interpret the Regulations in a manner “wholly consistent” with CUSMA. According to Janssen, the effect of CUSMA was to change the meaning of “innovative drug” to include enantiomers of previously approved drugs.

The Court agreed with the Minister that the language of the Regulations is determinative, notwithstanding the important context of CUSMA. Subsection C.08.004.1 implements the data protection provisions of CUSMA (Articles 20.48 and 20.49), and “do[es] not refer to the treaty “as is” or incorporate its language “without qualification”.” Accordingly, innovative drug “expressly excludes enantiomers of previously approved medicinal ingredients”.

In any event, the Minister reasonably concluded that the definition of “innovative drug” is compliant with CUSMA. CUSMA refers to a “pharmaceutical product that does not contain a chemical entity that has been previously approved” but does not define “chemical entity”. Canada was therefore free to exclude structural variations of previously approved drugs, such as enantiomers.

The Court concluded that the Minister’s interpretation of the Regulations was reasonable and the Minister reasonably concluded that SPRAVATO was not an innovative drug.

Minister’s refusal to consider Janssen’s request was reasonable

Janssen argued that the Minister (i) misapprehended that Janssen sought data protection from the date CUSMA came into force, and (ii) required that data protection be assessed prior to issuance of an NOC, which is not a requirement imposed by the Regulations. In Janssen’s view, 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 Regulations specify that data protection commences on the date an NOC issues, but not the date when eligibility is determined.

The Court explained that the Minister’s previous decision assessed the state of the law at the date the NOC was issued, which is consistent with the commencement of data protection according to the Regulations and CUSMA. In context, the Minister did not impose a requirement that eligibility must be determined prior to the issuance of an NOC.

As previously affirmed by the Court of Appeal, SPRAVATO was not an “innovative drug” when its NOC was issued. The Court held that reassessing SPRAVATO and awarding it data protection would be “a regulatory anomaly” and “inconsistent with purposive and contextual regulatory interpretation” in that SPRAVATO would be afforded data protection from a date and for a portion of a period where it was clearly not an “innovative drug”.

Finally, the Court held that any confusion as to Janssen’s request arose from Janssen’s submissions to the Minister, which sought relief “effective July 1, 2020”, which was the date CUSMA came into force.

The Court concluded that the Minister’s refusal to reassess data protection for SPRAVATO was reasonable.

Janssen has appealed. 

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