Thirty years of the Patented Medicines (Notice of Compliance) Regulations

By Gunars Gaikis, Orestes Pasparakis, Brian R. Daley, Allyson Whyte Nowak and Kristin Wall on December 3, 2023 Posted in Intellectual property, Life sciences and healthcare

This year marks the 30-year anniversary of the Patented Medicines (Notice of Compliance) Regulations (Regulations), introduced in 1993 to prevent patent infringement by linking the regulatory approval of generic or biosimilar drugs with the patent rights of innovators.  Since their genesis, the Regulations have been the focal point of most of the pharmaceutical patent litigation … Continue reading

What is a natural health product? Health Canada’s findings upheld by Federal Courts

By Paul Jorgensen and Kristin Wall on November 20, 2023 Posted in Life sciences and healthcare

In recent months, the Federal Courts have twice upheld Health Canada’s findings as to what is, and is not, a natural health product. The Courts’ decisions provide insight into how natural health products are distinguished, under federal law, from cosmetics and from drugs subject to the Food and Drug Regulations.  These distinctions are important as … Continue reading

Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

By Christopher A. Guerreiro and Kristin Wall on November 12, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a … Continue reading

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