Canada’s Intellectual Property Firm

Health Canada has issued updated guidance reflecting the September 21, 2017 amendments: Guidance Document: Patented Medicines (Notice of Compliance) Regulations (see our summary of the amendments here). The guidance, which became effective on May 11, 2018, also reflects current administrative practices, for example, by replacing references to “patent hold” with its currently preferred term, “intellectual property hold”. Further revisions include:

  • Directions on how to provide litigation information to Health Canada so that it is aware of barriers to the issuance of a second person’s NOC, given that the Minister is no longer a party to proceedings commenced under the amended PMNOC Regulations;

  • Example scenarios outlining when Certificates of Supplementary Protection will and will not be eligible for inclusion on the Patent Register and the process for eligibility assessments; and

  • Directions on how to renounce the application of the 24-month stay imposed on second persons when an action is commenced under subsection 6(1) of the amended PMNOC Regulations