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ARTICLE · 02 OCTOBER 2026

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

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.

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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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