News & Analysis as of

Minister of Health Notice of Compliance Canada

Smart & Biggar

Federal Court of Appeal restores Minister of Health’s decision to grant RUZURGI NOC despite FIRDAPSE data protection

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As previously reported, the Federal Court quashed a second decision by the Minister of Health (Minister) to issue a Notice of Compliance (NOC) to Médunik Canada (Médunik) for its amifampridine product, RUZURGI, following the...more

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Federal Court sets aside decision by the Minister of Health to issue RUZURGI NOC for the second time

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On March 10, 2022, for the second time, the Federal Court set aside a decision by the Minister of Health (Minister) to issue Médunik Canada (Médunik) a Notice of Compliance (NOC) for its amifampridine product, RUZURGI,...more

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Federal Court remits BELSOMRA CSP timing refusal for redetermination

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On August 9, 2019, the Minister of Health denied Merck’s application for a Certificate of Supplementary Protection (CSP) for Canadian Patent No 2,670,892 relating to the drug suvorexant (Merck’s BELSOMRA). On September 29,...more

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Supreme Court of Canada denies leave regarding lisdexamfetamine patent decision

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As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 52) affirming a Federal Court decision finding that the claims of a patent relating to lisdexamfetamine (Shire’s...more

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Apotex seeks leave to appeal lisdexamfetamine patent decision

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As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal from a decision holding that the claims of a patent relating to lisdexamfetamine (Shire’s VYVANSE) were valid and prohibiting the Minister of...more

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Federal Court quashes RUZURGI NOC and returns matter to the Minister of Health for redetermination

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Update: On redetermination, Health Canada issued a new notice of compliance for RUZURGI on June 24, 2021. Catalyst and Kye have sought judicial review (Court File No T-1047-21). On May 31, 2021, the Federal Court quashed a...more

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Federal Court of Appeal upholds Federal Court decision finding Shire’s VYVANSE patent valid

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Update: On October 7, 2021, the Supreme Court of Canada denied Apotex’s leave to appeal (Apotex v Shire, Docket No. 39662). The Federal Court of Appeal (FCA) recently dismissed an appeal by Apotex from a decision of the...more

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Federal Court denies stay of decision issuing NOC for RUZURGI

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On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...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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