The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor. Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations).
BGP Pharma ULC dba Viatris Canada (Viatris) filed an NDS seeking a notice of compliance (NOC) for an EYLEA® biosimilar called YESAFILI®. Viatris went on to serve Bayer Inc. (Bayer) with an NOA alleging non-infringement and invalidity of the two patents listed against EYLEA® on the Patent Register. In response, on June 15, 2022, Bayer and the patentee (collectively, the Applicants) commenced an action against Viatris under subsection 6(1) of the Regulations.
The Minister’s decision
In early 2023, Viatris transferred ownership of the NDS for YESAFALI® to Biosimilar Collaborations Ireland Limited (BCIL). The Minister then advised the Applicants to make BCIL a defendant to the on-going subsection 6(1) action. The Applicants refused, taking the position that BCIL could not adopt the steps previously taken by Viatris to comply with the Regulations, including service of the NOA, and had to serve its own NOA to challenge the listed patents. The Minister rejected the Applicants’ position. The Applicants applied to the Federal Court for judicial review.
The Minister’s decision was reasonable
The Court found that the standard of review was reasonableness. The Court then concluded that the Applicants had not established that the Minister’s decision was unreasonable, including for the following reasons:
- Transfer of NOA implicit to the Regulations: The Court rejected the Applicants’ argument that because the Regulations do not expressly allow for a transfer of an NOA when there is a change in ownership of an NDS, the Minister could not read-in such authority. Rather, the Court found that the transfer of an NOA is implicit from the scheme of the Regulations and underlying policies. Importantly, on the facts, the transfer of the NDS to BCIL did not change the drug product or the allegations in the NOA.
- Right to renounce stay not affected: The Court found that the Applicants provided no evidence that the identity of a generic or biosimilar manufacturer is key to an innovator’s decision of whether to renounce the 24-month statutory stay at the outset of a subsection 6(1) action (to avoid the risk of section 8 damages). The Court noted that the Applicants did not renounce the stay in a closely-related subsection 6(1) action against BCIL.
The Applicants have appealed the Federal Court’s decision to the Federal Court of Appeal (Court File No. A-283-23).
Bayer Inc. v. BGP Pharma ULC (Viatris Canada), 2023 FC 1325