In three recent decisions, released in July and August, the Federal Court addressed questions concerning inventors and the “invention story” during Canadian patent litigation. The Court found that: (i) a patentee has no duty to facilitate inventor discovery; (ii) patentee’s
2023
Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document



On August 8, 2023, the Federal Court overturned Health Canada’s decision that a cannabis product, Edison Jolts, was to be classified as edible cannabis and not cannabis extract. The Court found that Health Canada had breached the duty of procedural…
Canada increases patent office fees for 2024



Beginning January 1, 2024, the Canadian Intellectual Property Office (CIPO) will implement the first substantial increases to its service fees since 2004. Many fees will increase by 25% of more, though some “low materiality fees” will remain capped…
Patent term adjustment: Canada consults on proposed regulatory framework
On August 7, 2023, the Canadian Intellectual Property Office (CIPO) launched a consultation on proposed features of regulations on patent term adjustment (PTA) in Canada (the Consultation).
The PTA system is intended to compensate patentees…
Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products



On July 31, 2023, Health Canada published its updated Guidance on distinction between advertising and other activities for health products (the Distinction Guidance). The Distinction Guidance outlines the factors that contribute to rendering a message or activity promotional in…
Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)


The pan-Canadian Pharmaceutical Alliance (pCPA) has recently published a set of principles and conditions for a pCPA Temporary Access Process (pTAP) which will inform the negotiation process and potential product listing agreements (PLAs) for…
Canada implements patent term adjustment as Bill C-47 becomes law



On June 22, 2023, Canada’s federal government passed legislation (Bill C-47) introducing a system of general patent term adjustment (PTA). The provisions amending the Patent Act to introduce PTA passed without substantive amendment and are scheduled…
PMPRB Update: Consultation on Amendment to the Interim Guidance re New Medicines


The Patented Medicine Prices Review Board (PMPRB) has launched a 60-day consultation on proposed changes to the price-review process set out in its Interim Guidance of August 18, 2022 (Interim Guidance). The proposed changes would affect…
Health Canada releases updated Certificate of Supplementary Protection guidance



On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale”…
The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations


The Ontario Superior Court (ONSC) has dismissed a claim for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the Regulations) brought by Apotex Inc. (Apotex) for lost sales of its Apo-Atomoxetine…