CANADA: LIFE-CYCLE INSIGHTS 

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IPD’s Canadian subscription offers read-through and improved forecasting for litigation events happening around the world, featuring:

  • Easy-to-use Canadian brand,

       biosimilar, and generic drug

       launch tracking schedules
 

  • Canadian litigation tracking and

       in-the-courtroom coverage with

       real-time email updates
 

  • ƒPersonalized consults with local Canadian intellectual property analysts 

  • ƒWeekly updates including Canadian trending drug topics, recent publications,

       and loss-of-exclusivity information
 

  • Complete drug information with locally reviewed Canadian indications
     

  • Comprehensive Canadian clinical development tracking in

       every major disease class

"How does Canada handle regulatory exlcusivity?

...Like in the United States, where the Food and Drug Administration, or FDA, is responsible for approving drug products both brand and generic, in Canada, that agency is called Health Canada. Like the USFDA, Health Canada grants certain regulatory exclusivity for branded drug products, but there are some differences. For example, in Canada, there's no orphan drug exclusivity, or new product exclusivity for branded drug products. Health Canada only grants regulatory exclusivity for the first approval of a novel active pharmaceutical ingredient, whereas in the United States, new chemical entity exclusivity means that generic manufacturers cannot file an application to market a generic drug product until four years after the brand gets approval, and generics cannot be approved themselves until at least seven and a half years after brand approval."

Our International Legal Analysts discuss the ins and outs of the Canadian patent and regulatory system juxtaposed against the system in the United States, including:

  • U nique features of Canadian patent and regulatory system

    • Health Canada

    • Patent linkage system

    • Regulatory exclusivity 

    • Orphan drug exclusivity​

    • Pediatric exclusivity

    • Patent term extensions

    • Certificates of supplementary protection

    • Read-through to the United States

  • Similarities and ​differences to the United States in litigation

    • Patented medicines notice of compliance

    • Invalidity challenges in court

    • Trial length​

    • Style of argument

  • Examples of Canadian trials

    • Invega Sustenna  

Listen to our podcast to learn more about the Canadian patent and regulatory system