Health Canada recently issued updated guidance on the Patented Medicines (Notice of Compliance) (PMNOC) Regulations reflecting the 21 September 2017 amendments (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). The guidance, which became effective on 11 May 2018, reflects existing administrative practices – for example, replacing references to 'patent hold' with Health Canada's preferred term, 'intellectual property hold'.
Further revisions include the introduction of:
- 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 notice of compliance, 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 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 Sub-section 6(1) of the amended PMNOC Regulations.
For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide. Register for a free subscription.
