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
-
New PMPRB Draft Guidelines outline administrative process for excessive price hearing recommendations
On December 19, 2024, the Patented Medicine Prices Review Board (PMPRB) released its Draft Guidelines for PMPRB Staff regarding Administrative Process for Excessive Price Hearing Recommendation (Draft...Read More -
Minister of Health announces new bilateral agreements with provinces for rare disease drugs
Canada’s first-ever National Strategy for Drugs for Rare Diseases includes up to $1.4 billion in funding for provinces and territories, to be negotiated through bilateral agreements.Read More -
Alexion awarded injunction against Amgen in SOLIRIS patent action; Court considers anticipation by incorporation by reference
The Federal Court has granted Alexion a declaration of infringement and an injunction preventing Amgen from manufacturing, using, and selling its proposed biosimilar eculizumab product, BEKEMV, in Can...Read More