ARTICLE
2 October 2026

Canada’s Linkage Litigation Scheme: A Comparison To Hatch-Waxman

SB
Smart & Biggar

Contributor

Smart & Biggar uncovers and maximizes intellectual property and technology assets for our clients. Today’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP strategy and protection. With over 125 lawyers, patent agents and trademark agents collaborating across five Canadian offices, Smart & Biggar is trusted by the world’s leading innovators to find value in their IP rights. As market leaders in IP, Smart & Biggar’s team is on the pulse when it comes to the latest developments and the wider industry changes that impact our clients. To stay informed, visit smartbiggar.ca/insights, including access to our RxIP Update (smartbiggar.ca/insights/rx-ip-updates), a monthly digest of the latest decisions and law surrounding the life sciences and pharmaceutical industries.
The September 2017 amendments to Canada's Patented Medicines Regulations introduced a new pharmaceutical patent linkage litigation scheme that more closely mirrors the US Hatch-Waxman system. This detailed comparison chart examines the similarities and differences between these two regulatory frameworks, highlighting key distinctions that remain despite the convergence.
Canada Intellectual Property

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.

Click to view the chart

*revised August 2026.

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.

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