Insights from Health Canada’s 2024–2025 Statistical Report on Canadian Pharmaceutical Patent Regime

On July 25, 2025, Health Canada released its annual 2024–2025 Statistical Report for the Patented Medicines (Notice of Compliance) Regulations, Data Protection, and Certificates of Supplementary Protection. The Report provides  detailed metrics on the administration of these regimes and related litigation.

Key Take-Aways from Health Canada’s Report

The 2024-2025 report illustrates a general decline in patent-related activity:

• Generic/Biosimilar Pharma Patent Litigation: 33 actions were filed under section 6 of the Patented Medicines (NOC) Regulations in 2024–2025, a slight decrease from 39 in 2023–2024 and 53 in 2022–2023. This marks the second consecutive year of decline. Interestingly, in 2024-2025, the number of biosimilar/generic submissions increased to 115 (up from 107 the prior year). In addition, during this period, no actions were decided on the merits, while 27 actions remain pending resolution. This data suggests a potential shift away from litigation and parties engaging in settlement.
• Patent Lists: Under Canada’s linkage regime, innovators can list eligible patents on the Canadian patent register (akin to US Orange book) in respect of generic/biologic drugs. The number of patent lists received dropped to 900 in 2024/2025, down from 988 the previous year. Similarly, additions to the Patent Register fell to 690, the lowest in five years. Rejections of patent lists remained relatively stable at 140.  14 patents were rejected for failing to meet the timing requirements.  As of March 31, 2025, the Patent Register included 1,411 Drug Identification Numbers, covering 686 medicinal ingredients.
• Data Protection: Canada has a 6 year (no generic/biosimilar filing) / 8 year (no approval) data protection regime. In 2024/2025, 32 human drugs were added to the Register of Innovative Drugs—27 without pediatric extensions (6 months) and 5 with a pediatric extension. Product types included 20 pharmaceuticals, 12 biologics, and no radiopharmaceuticals. For veterinary drugs, 2 were added. One judicial review application concerning data protection was filed during the fiscal year.
• CSP: In Canada, new pharmaceutical products can benefit from up to two years of extra protection covered by an eligible patent, from the expiry of the patent. The CSP regime saw 11 applications filed in 2024–2025. Health Canada issued 15 certificates with a full two-year term and 1 certificate with a shorter term. No applications were refused, and no judicial reviews were initiated. The average time for a first decision was 26 calendar days, meeting the 60-day service standard.

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Statistical Report 2024 / 2025

Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food and Drug Regulations), and Certificates of Supplementary Protection

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