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12 June 2017
On May 11 2017 the Senate passed Bill C-30 without amendment. Bill C-30 will implement the Canada-EU Comprehensive Economic and Trade Agreement (CETA). The bill was first tabled in the House of Commons on October 31 2016 (for further details please see "Bill C-30 to implement CETA: implications for pharmaceuticals"). The bill received royal assent on May 16 2017 (for further details please see "Bill C-30 receives royal assent"). The provisions will come into force only once changes to the related regulations are registered.
Bill C-30 includes a number of IP law provisions – the most notable relating to the protection of pharmaceuticals. CETA requires Canada to provide all parties to linkage litigation an effective right of appeal and also restoration of patent term to account for marketing delays resulting from the time required to obtain regulatory approval (for further details please see "Text of CETA released").
Bill C-30 addresses each of these issues:
The new linkage regime will be governed by regulations which are expected to be pre-published or published shortly. The CSP framework will be governed by the Patent Act and regulations to be pre-published or published.
The key features of CSPs under Bill C-30 are outlined below.
The term of the CSP will be calculated by subtracting five years from the period beginning on the filing date of the patent application and ending on the date on which the authorisation for sale is issued, for a maximum of two years. The CSP will take effect at the end of the patent term, and the term may be reduced if the actions of the holder of the CSP result in a period of unjustified delay in obtaining the authorisation for sale.
An application can be filed if:
There will be a prescribed deadline for filing the application. Only one patent can be named in each application.
For further information on this topic please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's Ottawa office by telephone (+1 613 232 2486) or email (firstname.lastname@example.org). Alternatively, contact Nancy Pei at Smart & Biggar/Fetherstonhaugh's Toronto office by telephone (+1 416 593 5514) or by email (email@example.com). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.
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