News & Analysis as of

Canada Notice of Compliance Generic Drugs

Smart & Biggar

Federal Court of Appeal confirms generic not required to address patent submitted before ANDS filing but listed after

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On August 8, 2025, the Federal Court of Appeal (FCA) determined that the Minister of Health’s decision to list Canadian Patent No. 2,970,315 on the Patent Register eight days after it was submitted to Health Canada was...more

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Proposed amendments to the Patented Medicines (Notice of Compliance) Regulations would expand definition of “claim for the...

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Update: Health Canada’s “Forward Regulatory Plan: 2023-2025” no longer lists the 2019 proposed amendments to the Food and Drug Regulations, “Regulations amending the Food and Drug Regulations (Improving Access to Generic...more

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Federal Court rejects Apotex’s invalidity allegations on claims for use of abiraterone acetate in combination with prednisone

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On October 29, 2019, the Federal Court issued its final decision under the pre-amended Patented Medicines (Notice of Compliance) Regulations: Janssen Inc v Apotex Inc, 2019 FC 1355. Justice Phelan granted Janssen’s...more

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Federal Court finds invalidity allegations relating to patent for metformin formulations not justified

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On March 8, 2019, Justice Fothergill granted Valeant Canada’s application for an order prohibiting the Minister of Health from issuing a notice of compliance to Generic Partners for its generic version of Valeant’s GLUMETZA,...more

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Apotex not permitted to plead promise-based invalidity grounds in Ontario section 8 lansoprazole action

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This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more

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