Canadian Certificates of Supplementary Protection (CSP)

Eligibility Criteria (Regulatory): 

• The regulatory approval for the drug must be the first for that particular drug as the statute authorizing the CSP specifically excludes minor variations of pharmaceuticals that have previously been granted marketing approval.
• Application for marketing approval in Canada must have been made within one year of a first international submission for regulatory approval of the drug in the EU (or any member country of the EU), the United State, Australia, Switzerland, or Japan.

Eligibility Criteria (Patent):

• Must be in force.
• Contain at least one claim covering the approved product, its use, or a method of producing the product. 

Time Period of Application:

• Either within 120 days following the issuance of regulatory approval in Canada or within 120 days of the patent’s grant date, whichever occurs later.

Maximum Period of Protection:

• 24 Months

Source: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/csp/csp-guide-cps-ld-eng.php

Fact File: Canada is the last country in G7 countries (Canada, France, Germany, Italy, Japan, United kingdom and the USA) to provide additional benefits!