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
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
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
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
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
On October 29, 2020, Justice Manson of the Federal Court ordered the Minister of Health to issue a notice of compliance (NOC) to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie’s HUMIRA: Fresenius Kabi v...more