The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs (for further details please see "Publication of final regulations on patent linkage and term restoration relating to CETA"). CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada. CSPs are similar to the EU and European Economic Area supplementary protection certificates, with a number of key differences, including a capped term of two years compared with five years in the European Union.
Feature |
Details |
Protection |
|
Governing legislation |
|
Guidance |
|
Register |
|
Drugs covered |
|
Term |
|
Paediatric extension |
|
Reduction in term |
|
Eligible patent |
|
Scope of protection |
|
Assertable under Linkage Regulations |
|
Where application filed |
|
Deadline for filing application |
|
Deadline for filing regulatory submission |
|
Protection by basic patent in force requirement |
|
First NOC/marketing authorisation requirement |
|
Number of CSPs per drug product |
|
Third-party filing |
|
Priority determinations |
|
Consideration of third-party observations during pendency of application review |
|
Declaration of invalidity of CSP application/CSP |
|
For further information on this topic please contact Nancy Pei at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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