Appellate Court confirms a NOA may be transferred to a successor second person on a New Drug Submission

The Federal Court of Appeal confirmed that transfer of a New Drug Submission (NDS) permits the new owner to adopt the Notice of Allegation (NOA) and all accompanying rights that belonged to the previous owner.

In 2023, after filing a NDS for YESAFILI® (an aflibercept biosimilar), BGP Pharma ULC served a NOA addressing two patents on the Patent Register against EYLEA®. BGP asserted it would not infringe the two patents owned by Regeneron (Bayer is the the market authorization holder for EYLEA®).

Upon serving the NOA, BGP Pharma assumed the role of a “second person” under the Patented Medicines (Notice of Compliance) Regulations and was granted certain benefits under section 5 of the Regulations.

A year later, the NDS was transferred from BGP Pharma to Biosimilar Collaborations Ireland Limited (BCIL).

The issue was whether BCIL must file its own NOA and re-start the process, or if it could rely on the NOA served by BGP Pharma. The Minister of Heath said BCIL could adopt the NOA and all surrounding rights and obligations. Bayer sought judicial review of the decision; which was dismissed by Justice Furlanetto of the Federal Court (2023 FC 1325) in October 2023.

In February 2024, the Federal Court of Appeal dismissed the appeal from the bench stating: “The Minister’s interpretation is consistent with the purpose and scheme of the Regulations … and his decision is both justifiable and justified and bears the hallmarks of reasonableness as required by Vavilov.”

Bayer Inc. v. BGP Pharma ULC d.b.a. Viatris Canada, 2024 FCA 29