Guidance on inventor discovery and “invention story” evidence in Canadian patent actions: Federal Court rules in favour of patentee

By Pardeep Heir, Paul Jorgensen and Kristin Wall on September 19, 2023 Posted in Intellectual property

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 counsel can object to questions during an inventor examination; and (iii) a patent challenger must … Continue reading

Federal Court finds that Health Canada breached procedural fairness by relying on an undisclosed internal guidance document

By John Greiss, Paul Jorgensen and Kristin Wall on September 5, 2023 Posted in Life sciences and healthcare

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 fairness by relying on a product classification factor in an internal guidance document that Health … Continue reading

Canada increases patent office fees for 2024

By Christian Cawthorn, Stephen Lam and Caroline Henrie on August 8, 2023 Posted in Intellectual property

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 at $150. Meanwhile, an increase to the employee cap for “small entity” status will increase the number … Continue reading

Patent term adjustment: Canada consults on proposed regulatory framework

By William Chalmers, Christopher A. Guerreiro, Anna Wilkinson and Kristin Wall on August 7, 2023 Posted in Intellectual property

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 for “unreasonable delays” by CIPO in issuing a patent. The Consultation seeks feedback on proposals that would impact the length of … Continue reading

Drug advertising: Updated guidance from Health Canada on the distinction between advertising and other activities for health products

By Sarah Pennington, John Greiss and Kristin Wall on August 3, 2023 Posted in Pharmaceuticals and life sciences

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 nature. Promotional messages and activities are subject to the advertising provisions of the Food and Drugs … Continue reading

Drug price negotiations: pCPA consulting on a Temporary Access Process (pTAP)

By Sarah Pennington and Kristin Wall on July 19, 2023 Posted in Pharmaceuticals and life sciences

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 drug products following the Canada Drug and Health Technology Agency (CADTH) time-limited recommendation pathway.  CADTH Time-Limited Reimbursement Recommendations Starting in the … Continue reading

Canada implements patent term adjustment as Bill C-47 becomes law

By Kristin Wall, Anna Wilkinson and Paul Jorgensen on June 26, 2023 Posted in Intellectual property, Pharmaceuticals and life sciences

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 to come into force no later than January 1, 2025. Canada’s new PTA system is intended to compensate patentees … Continue reading

PMPRB Update: Consultation on Amendment to the Interim Guidance re New Medicines

By Christopher A. Guerreiro and Kristin Wall on June 20, 2023 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

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 products classified as “New Medicines” with list prices that are below the median of prices in the basket of … Continue reading

Health Canada releases updated Certificate of Supplementary Protection guidance

By Sarah Pennington, Paul Jorgensen and Kristin Wall on May 29, 2023 Posted in Pharmaceuticals and life sciences

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” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative … Continue reading

The Ontario Superior Court dismisses a generic manufacturer’s claim for damages under section 8 of the PM(NOC) Regulations

By William Chalmers, David Yi and Allyson Whyte Nowak on May 4, 2023 Posted in Damages, Intellectual property, Life sciences and healthcare

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 product. The Court conducted a purposive interpretation of the Regulations and found that Apotex did not meet the statutory requirements … Continue reading