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23 October 2019
This article provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips.
As of 21 September 2019, Health Canada had granted 31 (18 in the second year) CSPs for drugs for human use and two for veterinary use; three applications were pending. Of the issued CSPs, 28 have the maximum two-year term. Health Canada's statistical report for CSPs also provides statistics, but covers the fiscal year ending on 31 March 2019.
Health Canada has rejected eight applications to date on the following bases(3):
Useful reminders include the following:
Among other tips, it is important to consider the possibility of a CSP early in the drug development and approval lifecycle. In addition, when choosing the patent, consideration should be given to the related regimes, including:
The following factors must also be considered:
In particular, when assessing the timing for patent grant, the following priority considerations must also be factored in:
For further information on this topic please contact Brandon Heard, Nancy Pei or Eric Saragosa at Smart & Biggar's Toronto office by telephone (+1 416 593 5514) or email (email@example.com, firstname.lastname@example.org or email@example.com). Alternatively, please contact Daphne Lainson at Smart & Biggar's Ottawa office by telephone (+1 613 232 2486) or email (firstname.lastname@example.org). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
(1) For further details on the first anniversary of the CSP regime, please see "Certificate of supplementary protection regime: first anniversary update", which provides a brief overview of:
(2) Given the similarities to the European supplementary protection certificates (SPCs), a chart comparing CSPs to SPCs is available here.
(3) Health Canada's statistical report is available here.
(4) Health Canada's guidance document is available here.
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