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Health Canada announces intent to develop a framework for orphan drug approval

  • Torys LLP
  • -
  • Canada, USA
  • -
  • October 5 2012

On October 3, 2012, Health Canada issued a press release announcing that it will develop a framework for the marketing approval of drugs to treat rare life-threatening, seriously debilitating or serious chronic rare diseases that are commonly referred to as "orphan drugs."

Supreme Court of Canada rules on data protection for drug innovators

  • Torys LLP
  • -
  • Canada
  • -
  • February 8 2012

On February 3, 2012, the Supreme Court of Canada released its long-awaited decision in Merck Frosst Canada Ltd. v. Canada (Health), the culmination of over a decade of litigation between Merck and the Minister of Health

Court affirms Health Canada’s broad discretion in review of drug submissions

  • Torys LLP
  • -
  • Canada
  • -
  • April 13 2010

In a recent decision of the Federal Court in Hospira Healthcare Corporation v. Canada (Attorney General) the Court affirmed that Health Canada has broad discretion in interpreting the Food and Drug Regulations to determine the content of an application for the marketing approval of a drug

Canada’s Federal Court of Appeal limits damages available to delayed generics

  • Torys LLP
  • -
  • Canada
  • -
  • June 8 2009

On June 4, 2009, in Merck Frosst Canada Inc. v. Apotex, Inc., the Federal Court of Appeal released an important decision limiting the range of damages available in actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations