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Drug pricing: PMPRB releases “What We Learned” Report on guidelines consultation

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By Kristin Wall & Christopher A. Guerreiro on February 16, 2024

The Patented Medicine Prices Review Board (PMPRB or Board) has released a “What We Learned” Report (the Report), marking the next step along the path to new Guidelines. The Report was prepared by Phoenix Strategic Perspectives Inc.…

Federal Court finds trademark confusion between the names of two approved biologics

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By Kristin Wall, Christopher A. Guerreiro & Fiona Sarazin on February 13, 2024

The Federal Court (FC) has found the brand name of a biologic drug to be confusingly similar to the brand name of a drug used to treat the same disorder, but with a different active ingredient. The application…

Federal Court of Appeal clarifies scope of implied licence on sale of patented medicine

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By Christopher A. Guerreiro, Brian R. Daley & Pardeep Heir on February 5, 2024

The Federal Court of Appeal (FCA) has held that the sale of a single dose of a patented multi-dose regimen does not provide an implied license to use the entire patented dosing regimen. As a result, it is…

Federal Court of Appeal Decides Case Splitting through NOAs is an Abuse of Process

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By Christopher A. Guerreiro, Brian R. Daley & Pardeep Heir on January 17, 2024

The Federal Court of Appeal (FCA) held that it is abuse of process for a generic or biosimilar manufacturer to split its case across multiple notices of allegation (NOAs) under the Patented Medicines (Notice of Compliance)…

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Federal Court upholds PMPRB jurisdiction based on “clinical similarities”

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By Kristin Wall & Christopher A. Guerreiro on January 15, 2024

The Federal Court (FC) has refused to overturn a decision of the Patented Medicine Prices Review Board (PMPRB or Board) that found that a patent can pertain to a medicine based on “clinical similarities” to the…

Pharma in Brief’s 2023 Year in Review and Trends for 2024

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By Kristin Wall, Christopher A. Guerreiro, Paul Jorgensen & Pardeep Heir on January 10, 2024

As you start the new year, allow us to recap 2023’s important legal and regulatory developments for Canadian pharma. We also flag what to watch out for in 2024. 

The most significant legal development in 2023 was the introduction of…

Federal Court Notice on Use of Artificial Intelligence in Court Proceedings

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By Christopher A. Guerreiro, David Yi & Julia Won on January 9, 2024

On December 20, 2023, the Federal Court (Court) published a notice on the use of artificial intelligence (AI) in proceedings (Notice) and interim principles and guidelines on the Court’s own use of AI (…

Federal Court refuses to issue injunction on infringed antibody formulation patent

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By Christopher A. Guerreiro, Brian R. Daley & Paul Jorgensen on December 17, 2023

On December 4, 2023, the Federal Court held that a patent claiming a formulation of adalimumab, a monoclonal antibody used to treat autoimmune diseases, is valid and is being infringed by a biosimilar product. However, the Court refused to issue…

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

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By Gunars Gaikis, Orestes Pasparakis, Brian R. Daley & Kristin Wall on December 3, 2023

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. …

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

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By Kristin Wall, Paul Jorgensen & Pardeep Heir on September 19, 2023

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…

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