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Results: 1-6 of 6

Health Canada’s guidance document on PM(NOC) Regulations now finalized

  • Torys LLP
  • -
  • Canada
  • -
  • April 4 2012

Health Canada has published an update to its guidance document on the application of the Patented Medicines (Notice of Compliance) Regulations

Innovative drugs sold under the special access programme can receive data protection in Canada

  • Torys LLP
  • -
  • Canada
  • -
  • May 18 2011

To benefit from data protection in Canada, a drug must meet the definition of "innovative drug" under the Food and Drug Regulations

Federal Court of Canada grants data protection to an old medicinal ingredient

  • Torys LLP
  • -
  • Canada
  • -
  • February 14 2012

In a recent decision Celgene Inc. v. Canada (Minister of Health) the Federal Court of Canada declared that a drug containing a previously approved medicinal ingredient is nevertheless subject to data protection

Doing a deal with pharma

  • Torys LLP
  • -
  • Canada
  • -
  • August 4 2011

From the perspective of the biotech company, there are several legal and business issues to consider when doing a deal with big pharma

Ontario court confirms generic drug manufacturers not entitled to unjust enrichment

  • Torys LLP
  • -
  • Canada
  • -
  • January 22 2013

On January 15, 2013, the Ontario Superior Court of Justice (Ontario Court) granted a motion for partial summary judgment in Apotex Inc. v. Abbott

Proposed amendment would exempt some generic submissions from Canada’s PM(NOC) regulations

  • Torys LLP
  • -
  • Canada
  • -
  • October 4 2011

Health Canada has released a proposed amendment to its guidance document Patented Medicines (Notice of Compliance) Regulations