Summary On July 24, 2020, the Federal Court dismissed an application for judicial review brought by Natco Pharma (Canada) Inc. (Natco) in respect of a July 26, 2019 decision (Decision) by the Minister of Health (Minister).  The Decision refused to accept Natco’s ANDS filing using Gilead Sciences Canada Inc.’s (Gilead) product DESCOVY as the Canadian Reference Product.  DESCOVY contains a combination of tenofovir alafenamide (TAF) hemifumarate and emtricitabine.  The Minister determined that TAF is a…

On July 10, 2020, the Federal Court issued a decision in a judicial review under the Certificate of Supplementary Protection Regulations (CSP Regulations). The application was brought by ViiV Healthcare ULC (ViiV) regarding a decision by the Minister of Health (Minister) refusing to issue a CSP in respect of Canadian Patent No. 2,606,282 (282 Patent) and the drug JULUCA® (Decision). The Federal Court determined that the Decision was unreasonable, including for failing to interpret the…

The Patented Medicine Prices Review Board (PMPRB or Board) has found that a patent can pertain to a medicine based on clinical similarities to the invention—even if the patent does not actually encompass the medicine. Background This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders. The patentee, Galderma Canada Inc. (Galderma), markets two adapalene products in Canada: Differin®, which contains 0.1% adapalene (DIFFERIN).…

On June 25, 2020, the Federal Court (FC) issued its latest Practice Direction and Order (FC Update) regarding Court operations during the pandemic, announcing that its Suspension Period will no longer be in force anywhere in Canada as of June 30, 2020. The FC Update also establishes guidelines for the transition toward more regular operations Background The FC Update is the fifth Practice Direction and Order issued by the FC in response to the Covid-19…

On June 11, 2020 the Federal Court (FC) and Federal Court of Appeal (FCA) published updated notices to gradually phase out the Suspension Period, which had previously been extended to June 15, 2020. Federal Court The FC’s June 11, 2020 Practice Direction and Order (Updated Order), amends its previous Practice Directions, which, subject to the amendments listed, continue to remain in force. The Updated Order provides for different procedures by region. Ontario, Québec and the…

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…