- Parties: The applicants were Bayer Inc. and Regeneron Pharmaceuticals, Inc. The respondents were BGP Pharma ULC d.b.a. Viatris Canada, and Biosimilar Collaborations Ireland Limited. 

- Subject Matter: This matter involved two Canadian patents listed on the Patent Register in association with the medicine aflibercept and its related drug product EYLEA®. The Minister of Health’s decision found that, through a transfer of ownership, Biosimilar Collaborations Ireland Limited (BCIL), as the successor second person on a new drug submission, could adopt the notice of allegation (NOA) of the predecessor second person, BGP Pharma ULC dba Viatris Canada. The Minister held that, with the transfer, BCIL obtained the benefits of s. 5 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133, including prior service of the NOA under s. 5(3). The applicants argued that the decision contravened the Regulations and that BCIL should serve a new NOA to comply with s. 5(3) of the Regulations. 

- Ruling: The court ruled in the respondents’ favour and dismissed the judicial review application. The court found the decision transparent, intelligible, justified, and consistent with the Regulations’ scheme, objectives, and purpose, including the treatment of submissions under the Food and Drug Regulations. 

- Date: The hearing was set on Sept. 19, 2023. The court released its decision on Oct. 3, 2023. 

- Venue: This was a federal case before the Federal Court. 

- Amount: The court awarded the respondents costs of the application at the high end of column IV of the Federal Court’s Tariff.