Amendments to the Patented Medicines (Notice of Compliance) Regulations and the Data Protection Provisions of the Food and Drug Regulations in Force

On October 18, 2006, the Government of Canada published the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations (PM (NOC) Regulations) and the Regulations Amending the Food and Drug Regulations (Data Protection) (Data Protection Regulations). They came into force on October 5, 2006. According to the Government, the amendments are intended to provide certainty, predictability and balance to the intellectual property framework for pharmaceuticals and bio-pharmaceuticals in Canada. The amendments contained in the PM (NOC) Regulations and the Data Protection Regulations attempt to clarify a number of areas that often give rise to disputes between innovative manufacturers and generic manufacturers. Or, as put by the Government, the Regulations are intended to strike a balance between effective patent enforcement for new drugs with the timely market entry of lower priced generics. For a review of the significant provision of the Regulations, link to the more detailed article with the same title. Summary and article by: Nick Wong