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Federal Court updates Guidelines for PMNOC proceedings

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By Paul Jorgensen & Daniel Daniele (CA) on December 1, 2024

On November 28, 2024, the Federal Court updated its guidelines for proceedings under the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) and other complex proceedings.  While the changes are not extensive, they create some new obligations and…

Supreme Court of Canada grants leave to appeal methods of medical treatment patentability decision

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By Pardeep Heir, Christopher A. Guerreiro & Anna Wilkinson on September 19, 2024

On September 19, 2024, the Supreme Court of Canada granted an application for leave to appeal in a case concerning the scope of patentable subject-matter in Canadian law, focusing on an area known as “methods of medical treatment” (MMT…

Federal Court addresses treatment and formulation patent claims in PMNOC case

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By Pardeep Heir, Christopher A. Guerreiro & Kristin Wall on August 27, 2024

The Federal Court (FC) has upheld the validity of a patent concerning treatment of idiopathic pulmonary fibrosis (IPF) and granted injunctive relief against the generic in an infringement action under section 6 of the Patented Medicines…

Federal Court of Appeal clarifies law on patentability of methods of medical treatment

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By Christopher A. Guerreiro, Pardeep Heir & Anna Wilkinson on February 29, 2024

The Federal Court of Appeal (FCA) has held that in order to determine whether a patent claims an unpatentable method of medical treatment (MMT), it is necessary to determine whether the use of the invention requires…

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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, Pardeep Heir & Anna Wilkinson 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, Pardeep Heir & Anna Wilkinson 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)…

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…

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