The provisional application of CETA takes effect in Canada today, ushering in a new era for pharmaceutical patent litigation. As part of this implementation, amendments to the Patent Act, the Patent Rules and the PM(NOC) Regulations, as well as the new Certificates of Supplemental Protection (CSP) Regulations, came into force today. See our previous posts on the new PM(NOC) Regulations and CSP Regulations for key details about these new schemes.
Health Canada issued a Guidance Document relating to the CSP Regulations and a Notice in Respect of the PM(NOC) Regulations. The CSP Guidance Document provides information on the procedure for filing a CSP application, timing requirements, eligibility information, CSP scope, and other details about the new CSP framework. The PM(NOC) Notice outlines updates regarding Health Canada’s administration of the Regulations, including information about how to notify Health Canada of proceedings, new Form Vs, and updated verification requirements.
Links to the new statutes and regulations are below: