CANADA: LIFE-CYCLE INSIGHTS 

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

Easy-to-use launch

tracking schedules

In-the-courtroom coverage with real-time email updates

 

ƒPersonalized consults with local analysts to get answers to questions like these ƒ

 

Dispute tracking

 

ƒAll-inclusive weekly

Watch List ƒ

Complete drug tear sheets with product information, indications, and

loss-of-exclusivity

scenario analyses

"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 are here today to discuss the in's and out's of the Canadian patent and regulatory system juxtaposed against the current system in the United States, including:

  • Unique features of Canadian health system

    • Regulatory Exclusivity 

    • Patent Linkage System

    • Canadian Court Proceedings

  • Health Canada

    • Orphan Drug Exclusivity​

    • Regulatory Data Protection

    • Pediatric Exclusivity

  • Certificates of Supplementary Protection

  • Differences in Litigation

    • Patented Medicines Notice of Compliance

    • Invalidity Challenges in Court

  • Similarities to U.S. System

    • Trial Length​

    • Style of Argument

  • Examples of Canadian Trials

    • Invega Sustenna 

Introduction to Canadian Patent and Regulatory System

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