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 Newsletter issue #33, January 2025

 

Federal Court Upholds Health Canada's Patent Listing Policy: Implications for Generic Drug Firms

Emerging Issue – Patent Registration

The Federal Court's decision in Serono v. Canada (Health) 2024 FC 1848 upheld Health Canada's policy of listing patents on the register only after determining their eligibility, rejecting Serono's argument for retroactive listing. This ruling clarifies that the submission of a patent does not guarantee its immediate addition to the register, impacting how generic drug firms like Apotex can proceed with regulatory submissions. The Court emphasized that the regulations require second persons to address only those patents that have been reviewed and found eligible. This decision reinforces the importance of the eligibility review process and provides clarity on the timing of patent listings, potentially affecting the strategies of pharmaceutical companies in protecting their patent rights. Discover key insights on this emerging issue by reviewing this Law360 article

For lawyers seeking further guidance on patent registration procedures and pharmaceutical patent law, the following materials and sources offer valuable insights

 

Emerging issue Resource In-product link PDF version

Federal Court Upholds Health Canada’s Patent Listing Policy: Implications for Generic Drug Firms

In win for generic drug firms, Federal Court upholds Health Canada’s patent listing policy

Law360 Canada N/A

Draft Legal Arguments Against Court’s Decision

Lexis+ AI – Prompt Result PDF download 

Regulation of Pharmaceuticals – Canadian Health Law Practice Manual

Lexis+ PDF download 

Register of Patents and CSPs

Lexis+ - Halsbury’s Laws of Canada – Patents, Trade Secrets and Industrial Designs PDF download 

Patentability Requirements  

Lexis+ - Practical Guidance PDF download 

 

 

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The Legal Brief is a newsletter exclusive to LexisNexis users. It contains current topical news items and recommendations for handling emerging legal issues. It leverages the full breadth and depth of LexisNexis® resources providing links to practical, up-to-date information that can help you prepare for the current legal issues and cases you are working on.