Executive Summary: Key Legal and Evidentiary Issues

• Dispute centered on timing rules for adding patents to the Patent Register under the Patented Medicines (Notice of Compliance) Regulations.

• Question over whether a patent is considered “added” on the date of submission or the date eligibility is confirmed by Health Canada’s OSIP.

• Bayer claimed the OSIP’s interpretation unfairly favored the biosimilar manufacturer, Amgen.

• Federal Court and OSIP both relied on prior case law (Eli Lilly, 2009 FC 474) to affirm eligibility confirmation date as controlling.

• The “frozen register” rule under subsection 5(4) excluded patents added after the filing date of a new drug submission from the requirements for second persons.

• Appeal dismissed as OSIP’s decision was found reasonable and consistent with statutory context and purpose.

Facts and outcome of the case

Background
Bayer Inc., the innovator company, submitted a patent list for Canadian Patent No. 2,970,315 related to its drug EYLEA (aflibercept) on August 22, 2023. The Office of Submissions and Intellectual Property (OSIP), on behalf of the Minister of Health, found the patent eligible for listing on August 30, 2023. In the interim, on August 24, 2023, Amgen Canada Inc. filed a new drug submission (NDS) for its biosimilar version of aflibercept. While the OSIP deemed Amgen’s NDS administratively complete on August 31, it treated the submission date of August 24 as the filing date. Since the 315 Patent was not yet on the Patent Register on that date, Amgen was not required to address it under section 5 of the Regulations due to the “frozen register” rule in subsection 5(4).

Bayer’s arguments
Bayer argued that the date of submission should govern for both patent lists and NDS filings, or alternatively, that the OSIP’s reliance on the eligibility confirmation date created an imbalance favoring biosimilar manufacturers. Bayer claimed that the Regulations do not contemplate any time gap between submission and addition to the Patent Register and suggested that applying different date rules for innovators and generics undermined fairness. Bayer also sought to distinguish the Eli Lilly precedent, asserting it was not binding and arose from materially different circumstances.

OSIP and Federal Court decisions
The OSIP issued a 27-page decision analyzing the text, context, and purpose of the Regulations. It concluded that a patent list is added to the Patent Register only on the date eligibility is confirmed, with no retroactive effect to the submission date. The Federal Court, applying a reasonableness standard of review, upheld the OSIP’s interpretation as consistent with the statutory scheme and prior jurisprudence.

Federal Court of Appeal’s decision
On appeal, the Federal Court of Appeal agreed with the Federal Court’s reasoning and dismissed Bayer’s appeal. The Court found the OSIP’s interpretation reasonable, noting that the “frozen register” rule intentionally allows for situations where a subsequent entry manufacturer may file during the eligibility review period and avoid addressing the pending patent. The Court emphasized that this was a policy choice embedded in the Regulations and that innovators have recourse under the Patent Act for any subsequent infringement.

Outcome and costs
The appeal was dismissed. The respondents, Amgen Canada Inc. and the Minister of Health, were awarded costs of $4,500 each, for a total of $9,000.