News & Analysis as of

Notice of Compliance Prescription Drugs

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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 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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Amended PMNOC Regulations: Second Anniversary Update

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September 21, 2019 was the second anniversary of the coming into force of the amended Patented Medicines (Notice of Compliance) Regulations (Regulations) heralding significant changes to the landscape for pharmaceutical...more

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Rx IP Update - May 2019

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IN THIS ISSUE: - Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine - FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more

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Infringement based on making/selling under existing NOC for one strength struck from action under the PMNOC Regulations triggered...

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The Federal Court has granted in part Pharmascience’s motion to strike out portions of Teva’s statement of claim under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) relating...more

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RX IP Update - January 2017

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Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more

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