The Federal Court of Appeal in Canada (Attorney General) v Catalyst Pharmaceuticals, Inc (2023 FCA 3) has upheld the Minister of Health's decision that data protection applies only where a manufacturer seeks a Notice of Compliance (NOC) by relying on data from an innovative drug, and provided guidance for determining whether such reliance exists.

Background

On November 6, 2019, Catalyst filed a new drug submission (NDS) for its drug FIRDAPSE, and a NOC was issued for FIRDAPSE on July 31, 2020. On December 20, 2019, Médunik filed an NDS for RUZURGI, a drug with ingredients similar to FIRDAPSE. A NOC for RUZURGI was issued on August 10, 2020. Although the two NDS' were pending at the same time, and reviewed in parallel, the Minister only considered the applicability of data protection prior to approving RUZURGI, and not FIRDAPSE. This is because FIRDAPSE was designated as an innovative drug. Consequently, once the NOC for FIRDAPSE was issued, the Minister was required to consider data protection prior to approving RUZURGI. By issuing a NOC for RUZURGI, it is implicit that the Minister determined that the data protection regime did not apply.

Catalyst sought judicial review of the Minister's decision to issue a NOC for RUZURGI, arguing that RUZURGI's reference to studies found in the US submission for FIRDAPSE was a comparison with an innovative drug, such that data protection applied. The Federal Court remitted the matter to the Minister for redetermination (see Catalyst Pharmaceuticals, Inc v Canada (Attorney General), 2021 FC 505).

In its redetermination, Health Canada concluded that data protection only prohibits the Minister from approving an NDS if an innovative drug existed at the time the NDS is filed.[1] As FIRDAPSE was not yet designated an innovative drug when the NDS for RUZURGI was filed, Health Canada concluded that data protection did not apply (the "Timing Issue").[2] Health Canada further concluded that the RUZURGI NDS referred to the FIRDAPSE studies as publicly available information, and therefore it was not a direct or indirect reliance on data contained in the FIRDAPSE NDS (the "Reliance Issue").[3]

Catalyst then sought a second judicial review of the redetermination. In reaching its decision, the Federal Court commented on the Timing Issue that the regulations for data protection[4] require a continuous verification until the NOC is issued. On the Reliance Issue, the Court criticized Health Canada for considering whether it "relied on the FIRDAPSE studies rather than whether Médunik did so."[5] The Court concluded, based on evidence not considered in Health Canada's redetermination, that "the FIRDAPSE studies  were  relied on."[6] Consequently, the Federal Court granted Catalyst's application and again remitted the matter to the Minster for further redetermination (see Catalyst Pharmaceuticals, Inc v Canada (Attorney General), 2022 FC 292). This most recent Federal Court decision was appealed by both parties.

The Federal Court of Appeal's decision

The Federal Court of Appeal concluded that the Federal Court should not have interfered with the Minister's decision to issue an NOC, and set aside the Federal Court's decision.

Reliance Issue

The Federal Court of Appeal concluded that Health Canada's redetermination adequately explained the Minister's reasoning.[7] Since Health Canada "did not find the FIRDAPSE studies necessary to assess the safety and efficacy of RUZURGI, then it is reasonable to conclude that Médunik was not relying on them to obtain its NOC."[8]

Meanwhile, the Court of Appeal held that a reviewing court could not "reach its own conclusion on the importance of documents that were available for consideration by a decision maker without deference to the decision maker's assessment."[9]

While the Federal Court had found that Health Canada's inquiry about missing RUZURGI studies and Médunik's response demonstrated that Médunik relied on the FIRDAPSE studies in seeking its NOC, the Court of Appeal disagreed, concluding that "Médunik's reference to "available nonclinical data" did not necessarily refer to the FIRDAPSE studies, and the Federal Court should not have read it as an acknowledgement that Médunik relied on [the FIRDAPSE] studies to support the [RUZURGI] NDS."[10]

With regard to Health Canada's internal discussions surrounding the removal and later restoration of reference to the FIRDAPSE studies in the NDS for RUZURGI, the Court of Appeal emphasized that the key issue is "whether there is any flaw in the Minister's ultimate decision that is of sufficient importance to render it unreasonable."[11] The Court of Appeal found that the internal discussions do not indicate "that the FIRDAPSE studies were relied upon to establish RUZURGI's safety and efficacy."[12] Therefore, the discussions were not sufficient to establish that the Minister's ultimate decision is unreasonable.[13]

Timing Issue

The Federal Court of Appeal chose to not address the Timing Issue. It noted that the Timing Issue and the Reliance Issue are independent, and it is unnecessary to consider the Timing Issue given its ruling on the Reliance Issue.[14]

[1] Canada (Attorney General) v Catalyst Pharmaceuticals, Inc, 2023 FCA 3 at para 8 [Catalyst].

[2] Ibid.

[3] Ibid at para 9.

[4] Food and Drug Regulations, CRC, c 870, s C.08.004.1.

[5] Catalyst, supra note 1 at para 13.

[6] Ibid.

[7] Ibid at para 44.

[8] Ibid.

[9] Ibid at para 49.

[10] Ibid at para 56.

[11] Ibid at para 57.

[12] Ibid at para 58.

[13] Ibid at para 58.

[14] Ibid at para 22.