On May 26, 2023, the Minister of Health issued a decision that Biosimilar Collaborations Ireland Limited (BCIL) was entitled to the benefit of a notice of allegation (NOA) served by the previous owner of a new drug submission (NDS) for YESAFILI, an aflibercept biosimilar (Bayer’s EYLEA). On October 3, 2023, the Federal Court determined that the Minister’s decision was reasonable and dismissed Bayer and Regeneron’s application for judicial review: Bayer Inc v BGP Pharma ULC (Viatris Canada), 2023 FC 1325.

Background

The NDS for YESAFILI was initially filed by Viatris Canada, who served an NOA on Bayer in respect of two patents listed for EYLEA. In response, Bayer and Regeneron commenced a proceeding against Viatris Canada pursuant to subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations).

Ownership of the YESAFILI NDS was subsequently transferred to BCIL.

Following correspondence with the parties, the Minister issued a preliminary decision that BCIL should be added as a defendant in the subsection 6(1) action and “BCIL could adopt the steps previously taken by Viatris to comply with section 5 of the Regulations, including service of the NOA in respect of the listed patents.” The Minister issued a decision affirming this opinion following further submissions.

The Applicants sought judicial review, seeking a declaration that BCIL had not complied with section 5 of the Regulations and cannot adopt the steps taken by Viatris Canada to do so.

Standard of Review

The Court determined that the appropriate standard of review was reasonableness. According to Justice Furlanetto, “the crux of the Decision concerns a second person’s obligations under section 5 of the Regulations following a transfer of ownership of an NDS.” The Minister is responsible for determining these obligations.

The Minister’s Decision was reasonable

Regulations and Food and Drug Regulations (FDR) support transfer of NOA

The Court determined that, while not explicit, “the transfer of the NOA is implicit from the scheme of the Regulations and its underlying policies, including those relating to the associated review and handling of drug submissions under the FDR.”

During review of a submission, policy permits the manufacturer name to be changed (e.g., by merger, buyout, or transfer of rights in the drug) without changing the filing date, requiring the submission to be refiled, or requiring the sponsor to address additional patents added to the Patent Register. After review of an NDS, the manufacturer name may be changed by an administrative NDS without separately engaging section 5 of the Regulations.

The Applicants conceded that the successor becomes the second person under the Regulations upon transfer of ownership. The Minister reasonably concluded that “[o]nce the successor second person assumes control over the submission, it acquires the rights to the Form V and the benefit of the allegations made,” including the steps taken to satisfy paragraph 5(3)(a) of the Regulations.

Further, requiring a successor second person to re-serve the same NOA is not supported by the Regulations, including:

• paragraph 5(3)(d), which contemplates changes to a submission that do not require a new NOA;
• subsection 5(6), which describes the circumstances in which an NOA must be retracted; or
• the objectives of the amended Regulations, which sought to eliminate multiple actions involving the same allegations.

No loophole permitting premature issuance of NOC

The Court disagreed that the Minister’s decision would permit premature issuance of an NOC before a successor second person could be added to the subsection 6(1) action. Justice Furlanetto concluded that once an action is pending, “[t]he stay continues to apply in relation to the NDS and in respect of the successor second person even if they have not yet been named as a defendant to the action.” Notice of the change in ownership is provided to the first person pursuant to Health Canada’s Guidance Document on the Patented Medicines (Notice of Compliance) Regulations, and Rules 104 and 117 of the Federal Courts Rules permit the addition of the new defendant.

The Minister did not fail to consider right to renounce stay

The Applicants argued that a decision to renounce the 24-month stay depends on the identity of the second person, and therefore the Minister’s decision interfered with the Applicants’ right to make this choice. The Minister did not fail to consider this argument. The Court observed that the decision to renounce the stay must be made at the outset of litigation when there is inherent uncertainty as to the market and the distribution channels of the second person’s product. Further, the Applicants’ choice not to renounce the stay in response to a new NOA served by BCIL to preserve rights suggested that the change in the second person did not impact the Applicants’ choice.

Conclusion

The Court determined that the Minister’s “[d]ecision was transparent, intelligible, and justified and is consistent with the scheme, objectives, and purpose of the Regulations, including the treatment of submissions under the FDR.”

Bayer and Regeneron have appealed.

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