Canada: Federal Court Of Appeal Confirms Janssen's SPRAVATO Not Eligible For Data Protection

Update:  On November 10, 2021, the Minister rejected Janssen's second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The Minister concluded that SPRAVATO is not eligible for data protection because it is not entitled to a reassessment of data protection eligibility and, even if it were so entitled, it is not an "innovative drug". Janssen applied for judicial review of the Minister's decision on December 8, 2021 (Federal Court No. T-1867-21).

As previously reported, Zinn J. of the Federal Court had dismissed Janssen's application for judicial review of a decision by the Minister of Health (Minister) denying Janssen data protection for SPRAVATO, a drug indicated for the treatment of major depressive disorder. The Minister, relying on Takeda Canada Inc v Canada (Minister of Health), 2013 FCA 13 (Takeda), found that SPRAVATO is not an "innovative drug" eligible for such protection as its medicinal ingredient esketamine hydrochloride is an enantiomer of a previously approved drug. Justice Zinn held that the Minister's decision was reasonable.

On July 12, 2021, the Federal Court of Appeal (FCA) dismissed Janssen's appeal from Zinn J.'s decision: Janssen Inc v Attorney General of Canada (Minister of Health), 2021 FCA 137.

Janssen's primary argument on appeal was that the majority decision in Takeda  was wrongly decided, and that the FCA should reinterpret the Food and Drug Regulations  (Regulations) in a manner espoused by Stratas J. in his dissent. In other words, a drug that contains an enantiomer of a previously approved medicinal ingredient should not be automatically excluded from data protection, if generating the underlying data required "considerable effort".

As a preliminary matter, Janssen sought to adduce evidence that the Minister declined to consider a second request for data protection for SPRAVATO following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The FCA held that Janssen's new evidence regarding the impact of the CUSMA on the interpretation question at issue is inadmissible. CUSMA  came into force on July 1, 2020, before Janssen served and filed its application record in the Federal Court. However, Janssen did not make substantive submissions that CUSMA had changed the data protection regime in its memorandum of facts and law, or at the hearing in the Federal Court. Moreover, Janssen's new argument and documents are not relevant to determining whether the Minister's decision at issue was reasonable, as that decision was rendered more than a year before the coming into force of CUSMA.

Next, the FCA held that the Federal Court did not err in finding the Minister's decision was reasonable. Given that the factual differences between this case and Takeda  are not significant, it was reasonable for the Minister to follow the interpretation of the Regulations articulated in the majority decision in Takeda  in accordance with the doctrine of stare decisis. It was not incumbent on the Minister to re-do the analysis carried out by the Court in Takeda.

Finally, the FCA found no exceptional circumstances that would warrant a departure from Takeda. All members of the panel in Takeda  were well aware of the governing jurisprudence, legislation, international instruments, and relevant principles of statutory interpretation. Although Stratas J., the dissenting judge in Takeda, is a member of the present panel, stare decisis  provides that judges should follow prior decisions, even if they disagree. In addition, while Janssen argued that certainty and predictability of stare decisis  must sometimes give way where the economic, social and political circumstances underlying a decision have changed, the FCA found no admissible evidence indicating that circumstances have changed since Takeda  was decided in 2013.

Should you have any questions, please do not hesitate to contact a member of the Pharmaceutical Litigation Group.

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