Following pre-publication on July 15, and flowing from its commitments under the Comprehensive Economic and Trade Agreement (CETA), the Certificates of Supplementary Protection Regulations and the Regulations Amending the Patented Medicines (Notice of Compliance) (PMNOC) Regulations came into force on September 21, together with corresponding amendments to the Patent Act. We prepared a chart comparing the new litigation scheme to the US Hatch-Waxman scheme. We also reported on Health Canada's guidance document regarding CSPs and notice under the amended PMNOC Regulations and the Federal Court's practice notice regarding actions under the amended PMNOC Regulations. By year-end, four actions (all relating to trastuzumab) had been commenced under the amended PMNOC Regulations and four CSP applications had been filed.

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