On May 26, 2023, the Minister of Health determined that Biosimilar Collaborations Ireland Limited was entitled to the benefit of section 5 of the Patented Medicines (Notice of Compliance) Regulations (Regulations), including prior service of a Notice of Allegation by the previous owner of the new drug submission for YESAFIL (an aflibercept biosimilar). As previously reported, the Federal Court determined that the Minister of Health’s decision was reasonable. On February 13, 2024, the Federal Court of Appeal (FCA) dismissed Bayer and Regeneron’s appeal: Bayer Inc v BGP Pharma ULC (Viatris Canada), 2024 FCA 29.

The FCA held that the Federal Court did not err in determining or applying the appropriate standard of review (reasonableness). The FCA explained that administration of section 5 of the Regulations “squarely falls within the purview of the Minister”, and the “Court’s role as first instance decision-maker arises only when a proceeding is initiated under section 6 of the Regulations”.

Any further appeal would require leave from the Supreme Court of Canada.

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