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Federal Court upholds patent validity and issues injunction and delivery up order against biosimilar

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By William Chalmers, Christopher A. Guerreiro & Kristin Wall on May 25, 2025

The Federal Court (FC) has upheld the validity of a patent concerning a biologic drug used to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare blood disorder, in an infringement action under section 6 of…

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Canada expanding national pharmacare and rare disease drug coverage

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 27, 2025

March 2025 saw a flurry of developments in Canada’s emerging national funding systems of drugs for rare diseases and pharmacare. All of Canada’s 13 provinces and territories have now reached bilateral agreements with the federal government to cover certain drugs…

British Columbia becomes second province to sign pharmacare agreement

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 7, 2025

On March 6, 2025, British Columbia became the second province to announce the signing of a pharmacare agreement with Canada’s federal government. Manitoba was the first province to do so, on February 27, 2025 (our report here).

British Columbia’s

…

Agile licensing, risk, biologics, and more: Wide-ranging amendments to Canada’s drug and medical device regulations

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on March 3, 2025

Canada has made wide-ranging amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR). The amendments are intended to deliver on Health Canada’s modernization commitments, codify long-standing policies and practices, and implement…

National pharmacare in Canada: First-ever funding agreement announced

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on February 27, 2025

On February 27, 2025, the governments of Canada and of the Province of Manitoba announced the first-ever national pharmacare funding agreement. The two governments also announced a funding agreement under the National Strategy for Drugs for Rare Diseases.

Pharmacare

…

Drug shortages: New requirements proposed for the Food and Drug Regulations

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By Julia Kafato, Sarah Pennington, Paul Jorgensen & Kristin Wall on February 12, 2025

Health Canada has proposed additional regulations intended to prevent, mitigate, and respond to drug shortages. The proposed amendments to the Food and Drug Regulations (Regulations) include new requirements for drug market authorization holders to develop shortage prevention and…

Pharma in Brief’s 2024 Year in Review and Trends for 2025

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By Kristin Wall, Christopher A. Guerreiro, Paul Jorgensen & Sarah Pennington on February 3, 2025

2024 saw no shortage of headlines in the Canadian pharma space. Here we look back on the year’s most notable legal and regulatory developments and look forward to areas to watch in 2025.

1. National pharmacare comes to Canada

In…

Drug Pricing Update: PMPRB launches consultation on Draft Guidelines for price review

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By Christopher A. Guerreiro & Kristin Wall on December 20, 2024

The Patented Medicine Prices Review Board (PMPRB or Board) has released a draft of its new price review Guidelines (the Draft Guidelines) for consultation. The Draft Guidelines outline a proposed new price-review process for Board Staff, with…

Federal Court declares patent ineligible for listing during PM(NOC) infringement action

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By Pardeep Heir, Christopher A. Guerreiro & Kristin Wall on December 16, 2024

The Federal Court (FC) has provided fresh guidance on applying the test for challenging patent-listing eligibility in an infringement action under the Patented Medicines (Notice of Compliance) Regulations (the Regulations). Granting the delisting motion before it, the…

Recent developments in Canadian national pharmacare and funding for drugs for rare diseases

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By Sarah Pennington, Paul Jorgensen & Kristin Wall on December 10, 2024

Canada’s emerging national systems of pharmacare and public funding for drugs for rare diseases (DRDs) had key developments last week. On December 4, the Minister of Health (Minister) asked Canada’s Drug Agency-L’Agence des médicaments du Canada…

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