On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI, despite data protection for FIRDAPSE (containing amifampridine phosphate), and sent the matter back for a new determination: Catalyst Pharmaceuticals, Inc v Canada (Attorney General), 2022 FC 292.

As previously reported, Catalyst Pharmaceuticals, Inc (Catalyst) filed a new drug submission (NDS) for FIRDAPSE one month before Médunik filed its NDS for RUZURGI. Médunik’s product monograph submitted with its NDS contained references to FIRDAPSE data (“impugned information”).

The Minister issued the FIRDAPSE NOC on July 31, 2020, and recognized it as an innovative drug eligible for data production. Shortly thereafter on August 10, 2020, Médunik was issued an NOC for RUZURGI (the “first RUZURGI NOC”). The decision to issue the first RUZURGI NOC was quashed by the Court and sent back for redetermination on May 31, 2021 (2021 FC 505). On June 24, 2021, the Minister issued a new NOC to Médunik.

Subsection C.08.004.1(3) of the Food and Drug Regulations provides:

(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,

(a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and

(b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

At the heart of this second judicial review application is the Minister’s determination that subsection C.08.004.1(3)(b) does not prohibit the issuance of an NOC for RUZURGI because Médunik was not seeking approval “on the basis of a direct or indirect comparison” to FIRDAPSE as approved and marketed in Canada.

For the reasons outlined below, Justice St-Louis concluded that the Minister’s decision does not fall within a range of possible, acceptable outcomes.

First and foremost, St-Louis J. found the Minister’s interpretation of the data protection provisions with respect to the timing issue unreasonable. The Minister argued that subsection C.08.004.1(3)(b) can be engaged only when the filing prohibition at subsection C.08.004.1(3)(a) is first engaged. In other words, paragraph (b) is engaged only if a manufacturer, initially prohibited from filing its NDS, becomes eligible after the 6-year no-filing period has lapsed.

St-Louis J. rejected the Minister’s interpretation and held that subsection C.08.004.1(3)(b) contains two clear and distinct prohibitions. The first is that the Minister “shall not approve that submission” set out in paragraph (a). And the second is that the Minister “shall not issue a notice of compliance in respect of the new drug”. If an innovative drug is placed on the Register after another manufacturer’s NDS is filed, but before its NOC is issued, and if this other manufacturer seeks its NOC on the basis of a direct or indirect comparison with the innovative drug, the regulatory text prohibits the Minister from issuing an NOC. Moreover, the regulations do not indicate that the evaluation of a possible comparison with an innovative drug must be assessed strictly at the time of filing. On the contrary, the language of subsection C.08.004.1(3) (b) suggests a continuous verification until the NOC is issued.

Second, with respect to whether Médunik made a “direct or indirect comparison” to FIRDAPSE, St-Louis J. found that the Minister failed to apply the test he put forth (that the manufacturer must rely on the innovative drug data) and instead imposed a requirement that the Minister must rely on the innovative drug data. St-Louis J. further found that the Minister failed to take into account contradictory evidence that suggested that the impugned information was essential for market authorization.

The Attorney General of Canada may appeal as of right.

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