On June 19, 2020, the Patented Medicine Prices Review Board (PMPRB) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. The revised Guidelines outline new price tests for existing and new patented medicines, as well as a revised risk-based system for reporting and investigations. They will be available for public comment until July 20, 2020. Background Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1,…

We previously reported on the Ontario government’s efforts to manage the risk of drug shortages in the early days of the pandemic. Those efforts included a recommendation that pharmacies dispense no more than a 30-days’ supply of medication to patients under the Ontario Drug Benefit (ODB) program. Because the policy resulted in additional dispensing fees being charged to patients, the government took further regulatory action to ensure that patients would not be required to pay…

On May 22, 2020, the Federal Court granted a motion seeking an order that the issue of infringement in an action brought pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations (Regulations) would not be moot notwithstanding that the trial was set to proceed after the expiry of the relevant patent. Background Sandoz served a Notice of Allegation on AstraZeneca alleging non-infringement, invalidity and ineligibility for listing of AstraZeneca’s patent for saxagliptin…

This week has seen a number of developments relating to the Patented Medicine Prices Review Board (PMPRB), including a six-month delay to the implementation of amendments to the Patented Medicines Regulations and renewed consultation by the Board on revised Draft Guidelines to implement those amendments. Meanwhile, the Federal Court is now considering a judicial review of those amendments. Amendments to the Patented Medicines Regulations delayed The federal government has delayed the implementation of the Regulations …

The Federal Court of Appeal (FCA) and the Federal Court (FC) have extended their Suspension Periods to June 15, 2020. Federal Court of Appeal On May 28, 2020, the FCA issued a Notice to the Parties and the Profession extending the Suspension Period to June 15, 2020. Federal Court On May 29, 2020, the FC issued an updated Practice Direction and Order (FC Update), also extending the Suspension Period to June 15, 2020. Pursuant to the…

The Federal Court has dismissed two infringement actions brought against defendants under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (Regulations), following a common trial on the validity of Canadian Patent No. 2,562,277 (277 Patent). The Court found that all the asserted claims – to uses for treating multiple sclerosis (MS) – were obvious and that some were anticipated. This is the third decision on the merits of an action under the Regulations…

The Federal Court of Canada has embraced virtual hearings as the best solution to the prolonged Covid-19 shutdown. While acknowledging some litigants’ concerns pertaining to procedural fairness and information security in recent rulings, the Court is more concerned that justice delayed can become justice denied. Videoconferencing will not impede the Court’s ability to assess the credibility of witnesses The unprecedented suspensions following Covid-19 saw some litigants facing lengthy suspensions mid-way through trial. In Rovi Guides, …