Industry Canada has now enacted the amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations) in order to permit claims to compounds to be listed against multiple drug combination products. The regulation is dated June 18, 2015, and we understand that it is to be published July 1, 2015. We attach a copy of the regulation and royal assent.
The Regulations published are in substantially the same form as previously presented in the Notice of May 3, 2015. The amendments include new section 3.2(1) and (2) which permit, the resubmission of patent lists where a patent was deleted or was refused to be added, during a specified period and on the basis of the Viiv decision, within 30 days of the Regulations coming into force.
In the event that a patent has not been listed or has been deleted from the Patent Register, we recommend early review and corrective action be taken expeditiously in advance of the 30-day deadline of July 18, 2015.