The September 21, 2017 amendments to the Patented Medicines (Notice of Compliance) Regulations (see our article here) introduced a new scheme for pharmaceutical patent linkage litigation in Canada. That scheme is now much closer to the US Hatch-Waxman scheme, but with remaining key differences, as shown in the chart below. A special thank you to Brian Coggio of Fish & Richardson for contributing the Hatch-Waxman details.

*revised January 2025.
Related Publications & Articles
-
Update on biosimilars in Canada – June 2025
This article provides an update on developments in the biosimilar space in Canada—regulatory, approvals, pending submissions, litigation, and market access.Read More -
2025 mid-year highlights in Canadian life sciences IP and regulatory law
In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories.Read More -
Federal Court of Appeal confirms generic not required to address patent submitted before ANDS filing but listed after
On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to...Read More