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Federal Court finds reasonable Health Canada’s decision that enantiomer of previously approved drug not entitled to data protection

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

On September 18, 2020, the Federal Court dismissed Janssen’s application for judicial review of a decision of the Minister of Health (Minister) denying Janssen data protection for its drug SPRAVATO: Janssen Inc. v Canada (Attorney General), 2020 FC 904. SPRAVATO, which is indicated for treating major depressive disorder, contains as its medicinal ingredient esketamine hydrochloride, an enantiomer of ketamine hydrochloride which had been approved and marketed as KETALAR. Janssen sought data protection for SPRAVATO under the Food and Drug Regulations (Regulations), which provides data protection to an “innovative drug”, defined as:

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 salt, ester, enantiomer, solvate or polymorph.

The Minister’s decision

The Minister held that SPRAVATO, containing an enantiomer of a previously approved medicinal ingredient, is not entitled to data protection because it does not contain a medicinal ingredient that is a new chemical entity. The Minister relied on jurisprudence including Takeda v Canada (Minister of Heath), 2013 FCA 13 (Takeda), in which “innovative drug” was interpreted as meaning that all enantiomers are necessarily variations, and thus not entitled to data protection.

The Federal Court’s decision

Justice Zinn held the Minister’s decision was reasonable. Janssen submitted that Takeda was not binding on the Federal Court or on the Minister because the Supreme Court’s decision in Canada (Minister of Citizenship and Immigration) v Vavilov, 2019 SCC 65 (Vavilov) raised a new legal issue and represented a fundamental change in circumstances by establishing a new framework for reviewing administrative decisions that emphasizes interpreting legislation consistently with international obligations, applying the purposive approach when interpreting legislation, and ensuring decisions are reasonable and made based on all relevant factors. Justice Zinn rejected this argument, reasoning that there is nothing new in ensuring that legislation is interpreted consistent with international obligations, and further, that the majority in Takeda were aware of Canada’s treaty obligations that formed the basis of the relevant provisions of the Regulations. Justice Zinn added that although Vavilov establishes that administrative decisions are to be reviewed on a reasonableness standard with very limited exceptions, since the stricter correctness standard was applied in Takeda, it would be contrary to common sense and legal analysis that a reasonable interpretation to the opposite effect is to be preferred.

Janssen also argued that the facts are distinguishable from those in Takeda, where the same company developed both drugs and which were both used in the same manner for the same indication. While Zinn J. agreed that those facts were not present in this case, he noted that nothing in Takeda suggested that the interpretation was based on or influenced by those facts and concluded that such differences do not justify refusing to follow Takeda. Justice Zinn rejected Janssen’s submission that the definition of “innovative drug” in the Regulations is ultra vires because it is at odds with the definition in other countries. The treaties did not define the phrase “new chemical entity”, leaving each country to implement legislation based on its specific interpretation. Lastly, Zinn J. agreed with the Minister that examination of whether the generation of the data that supported the approval of the medicinal ingredient required “considerable effort” was not needed once it was found that SPRAVATO failed the eligibility test (i.e., was not a new chemical entity).

Janssen may appeal as of right.

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

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