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Apr 14, 2024 | 
lexblog.com | Christopher A. Guerreiro |Kristin Wall
The Patented Medicine Prices Review Board (PMPRB) has announced new details regarding the progress of its consultation on new price review Guidelines. The next phase of the PMPRB’s consultation will begin in summer 2024 with the release of a Discussion Guide. As we reported, the first phase of the consultation launched with a Scoping Paper in November 2023, by the release of a “What We Learned” Report in February 2024.
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Feb 29, 2024 | 
lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley
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 the exercise of professional skill and judgment. In the case of pharmaceutical dosing claims, the determination cannot be based solely on whether the claimed dosing and schedule is fixed or not.
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Feb 16, 2024 | 
lexblog.com | Christopher A. Guerreiro |Kristin Wall
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., which was commissioned to facilitate consultation with stakeholders and report on the presentations and discussions. As we reported, the PMPRB launched its consultation on new Guidelines with a Scoping Paper in November 2023.
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Feb 13, 2024 | 
lexblog.com | Fiona Sarazin |Christopher A. Guerreiro |Kristin Wall
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 of the ordinary test for trademark confusion was not affected by the fact that the names of both products had been approved by Health Canada. Novartis AG and Novartis Pharmaceuticals Canada Inc.
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Feb 5, 2024 | 
lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley
The Federal Court of Appeal (FCA) has held that the sale of 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 possible to infringe a dosing regimen patent by combining a first dose sourced from the patentee with other doses sourced from an unlicensed third party.
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Jan 18, 2024 | 
lexblog.com | Pardeep Heir |Christopher A. Guerreiro |Brian Daley
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) Regulations (Regulations). Reversing the Federal Court (FC), the FCA found that the generic or biosimilar manufacturer should raise all of its allegations in its NOA, and it should not keep some in reserve in the event that it is not initially successful.
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Jan 15, 2024 | 
lexblog.com | Christopher A. Guerreiro |Kristin Wall
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 invention—even if the patent does not actually encompass the medicine. The FC concluded that the Board’s decision was reasonable. This case concerns Canadian Patent No. 2,478,237 (the 237 Patent), which relates to the use of adapalene to treat dermatological disorders.
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Jan 10, 2024 | 
lexblog.com | Pardeep Heir |Paul Jorgensen |Christopher A. Guerreiro |Kristin Wall
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 a system of patent term adjustment (PTA). On the regulatory front, seemingly all of Canada’s agencies – the PMPRB, pCPA, CADTH, Health Canada – had important developments in 2023, including that CADTH is being expanded into a new agency: the CDA.
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Jan 9, 2024 | 
lexblog.com | Julia Won |Christopher A. Guerreiro |David Yi
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 (Policy). Declaration requirement. The Court now expects parties to proceedings before the Court to inform it, and each other, if they have used AI to create or generate new content in preparing a document filed with the Court. The Declaration.
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Dec 20, 2023 | 
lexblog.com | Christopher A. Guerreiro |Paul Jorgensen |Kristin Wall
The Government of Canada has announced the creation of the Canadian Drug Agency (CDA).
