Ontario proposes removing barrier to listing “well-established drugs” on its public formulary

By Julia Won, Paul Jorgensen and Kristin Wall on November 5, 2023 Posted in Pharmaceuticals and life sciences

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary.  The government is seeking feedback on the proposed amendments. Background A manufacturer can apply to … Continue reading

Drug pricing: PMPRB announces framework for new guidelines consultation

By Christopher A. Guerreiro and Kristin Wall on October 26, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023. The PMPRB has not had a full set of guidelines … Continue reading

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on October 24, 2023 Posted in Pharmaceuticals and life sciences

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence … Continue reading

Federal Court: Transferring drug submission does not require re-serving Notice of Allegation

By Pardeep Heir, Paul Jorgensen and Kristin Wall on October 22, 2023 Posted in Pharmaceuticals and life sciences

The Federal Court has upheld a decision of the Minister of Health (Minister) that the new owner of a biosimilar new drug submission (NDS) could adopt the notice of allegation (NOA) served by its predecessor.  Consequently, the new owner was properly added as a defendant to an on-going action under subsection 6(1) of the Patented … Continue reading

Drug pricing: PMPRB finalizes Interim Guidance amendments

By Christopher A. Guerreiro and Kristin Wall on September 28, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has amended its Interim Guidance to address prices of “New Medicines”, implementing a review threshold based on “below the median” of the PMPRB11 countries (Median International Price, MIP). “New Medicines” are defined as patented medicines that did not receive a PMPRB ceiling price as of July 1, 2022. … Continue reading

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