Patentees take note: September 21, 2018 marks the first anniversary of the Certificate of Supplementary Protection (CSP) regime in Canada, and it also marks the end of the transitional period for securing a CSP. As a result, the effective deadline for filing a CSP application is September 21, 2018 for applications where the first relevant foreign regulatory filing (as described below) occurred between September 21, 2016 and September 21, 2017.

A CSP is only available if the new drug submission (NDS) for a medicinal ingredient or combination of medicinal ingredients is timely filed in Canada. The NDS must be filed within a prescribed period of the filing of the first application for marketing approval of the medicinal ingredient or combination in the U.S., Europe or any member country thereof, Japan, Switzerland and Australia.

The prescribed period is 24 months if the CSP application is filed no later than the first anniversary of the CSP regime (i.e., September 21, 2018); otherwise, the prescribed period is 12 months. If the timely NDS filing requirement is not met, the CSP application will be refused.

A CSP application is due within 120 days of the later of the grant of marketing authorization by Health Canada (i.e., a NOC) and patent grant. However, this deadline is effectively advanced to September 21, 2018 for those CSP applications that are based on an NDS filed within 12-24 months of the first application for marketing approval in any of the noted regions.

There are other requirements for securing a CSP, as explained here. However, it is only the timely NDS filing requirement that will change after September 21, 2018.