Federal Court Of Canada Dismisses Application For Judicial Review And Finds Transferring Ownership Of New Drug Submission Does Not Require Re-Service Of NOA

On October 3, 2023, the Federal Court of Canada (the Court) issued its decision in Bayer Inc. v BGP Pharma ULC (Viatris Canada), 2023 FC 1325, dismissing Bayer Inc. and Regeneron Pharmaceuticals, Inc.’s (collectively, the Applicants’) application for judicial review of a decision by the Minister of Health (the Minister), which found that a transfer of ownership allowed Biosimilar Collaborations Ireland Limited (BCIL) to become the successor on a New Drug Submission (NDS) and receive certain benefits under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). This included benefiting from the prior service of a related Notice of Allegation (NOA) served by its predecessor, BGP Pharma ULC dba Viatris Canada (Viatris).

In 2022, Viatris filed a NDS seeking a notice of compliance (NOC) for a biosimilar to the drug product, EYLEA®. Viatris later served Bayer Inc. (Bayer) with an NOA alleging non-infringement and invalidity of the two patents listed for EYLEA®. This led Bayer to launch an action under subsection 6(1) of the Regulations and name Viatris as defendant. However, in early 2023, ownership of the NDS was transferred to BCIL and, despite disagreement from the Applicants, the Minister decided that BCIL could adopt the steps previously taken by Viatris with the NOA, including its service with respect to the listed patents.

In response, the Applicants brought the matter to the Court, seeking, among other things, an order quashing and setting aside the Minister’s decision, and a declaration that BCIL cannot adopt the steps previously taken by Viatris to comply with the Regulations. The Applicants argued that the Minister’s decision was unreasonable because it: 1) is outside the Regulations and not supported by the principles of statutory interpretation; 2) contemplates the premature issuance of an NOC to a successor second person; and 3) frustrates the Applicants’ express right to be able to renounce the 24-month stay.

Upon review, the Court was not persuaded by the Applicants that the Minister’s decision was unreasonable. Instead, the Court noted that the Regulations’ objective is to “balance effective patent enforcement over new and innovative drugs with the timely market entry of their lower priced generic competitors”, and an interpretation of the Regulations that requires a successor to re-serve the same NOA on a first person would be contrary to the objectives of the Regulations.

This led the Court to ultimately agree with BCIL and Viatris that the transfer of the NOA aligns with the scheme of the Regulations and dismiss the application with costs.

Summary By: Claire Bettio