CUSMA vs Food and Drug Regulations: Federal law predominates
Justice Stratas, writing a unanimous decision for the Federal Court of Appeal in Janssen v Attorney General of Canada, 2024 FCA 66,...Read More
FCA finds that data protection does not prevent a competing amifampridine product
The Federal Court Appeal has reversed the decision of Justice St-Louis (2022 FC 292) quashing the Minister of Health’s decision to issue...Read More
Post-filing Amendments are Subject to Data Protection
In Hospira Healthcare Corporation v. The Minister of Health, Attorney General of Canada and Sanofi-aventis Canada Inc., Hospira was unsuccessful in its...Read More
Drugs and Deference: Federal Court Confirms Reasonableness Standard for OPML’s Scientific Findings
Photocure ASA filed a new drug submission for CYSVIEW and requested that it be qualified as an “innovative drug” in order to...Read More
Supreme Court denies to hear DEXILANT innovative drug appeal
On June 12, 2013, the Supreme Court of Canada (“SCC”) dismissed, with costs, Takeda’s application for leave to appeal the judgment of the...Read More
Innovative drugs – “previously approved” does not mean “currently approved”
On February 15, 2013 the Federal Court of Appeal, in a 2:1 decision, released its Reasons or Judgment holding that Celgene’s thalidomide...Read More
Enantiomers are not innovative drugs – Federal Court of Appeal
On January 18, 2013, the Federal Court of Appeal, in a 2:1 decision, released its Reasons for Judgment holding that Takeda’s dexlansoprazole...Read More
Federal Court of Appeal affirms data protection for Sanofi’s ELOXATIN (oxaliplatin)
On April 10, 2012, the Federal Court of Appeal (“FCA”) dismissed Teva’s appeal of a data protection decision of Justice Campbell (2011...Read More
Federal Court of Canada rules thalidomide is innovative drug
Justice DeMontigny determined that thalidomide is an innovative drug entitled to data protection notwithstanding prior approval in the 1960s. Full decision may...Read More