Canada’s Intellectual Property Firm

Release of Statistical Report 2022/2023 for PMNOC Regulations, data protection and CSPs

Authored byUrszula Wojtyra

On June 23, 2023, the Office of Patented Medicines and Liaison of Health Canada released its Statistical Report 2022/2023 Patented Medicines (Notice of Compliance) Regulations, Data Protection (C.08.004.1 of the Food and Drug Regulations), and Certificates of Supplementary Protection (fiscal year ending March 31, 2023). Similar to previous such reports, the report includes information for the last 5 years about the eligibility of patents for listing on the Patent Register, the eligibility of drugs for listing on the Register of Innovative Drugs, Certificates of Supplementary Protection, and related court activity.

For the first time, this report breaks down submissions on “Intellectual Property Hold” to indicate the number of drug submissions that were placed on hold in each fiscal year, and the reason (i.e., patents, data protection, or both). For the 2022/2023 fiscal year, of the 123 submissions placed on Intellectual Property Hold, 83 were as a result of patents, 13 as a result of data protection, and 27 as a result of both patents and data protection.

Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.