On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection (CSP Guidance). The CSP Guidance was revised to reflect amendments to the definition of “authorization for sale” in the Certificate of Supplementary Protection Regulations (CSP Regulations) and to reflect changes to Health Canada’s administrative practices. Health Canada has also updated its fee for CSP applications.
A CSP can extend, for up to two years, patent protection for a drug containing a new medicinal ingredient or a new combination of medicinal ingredients. A CSP is intended to partly compensate innovators for time spent on research and on obtaining marketing authorization.
To qualify for a CSP, the drug must have received a Notice of Compliance (NOC), and that NOC must be “the first authorization for sale” in Canada with respect to the medicinal ingredient (or combination of medicinal ingredients). However, an earlier, limited-purpose authorization generally should not prohibit a drug that later obtains an NOC from also obtaining a CSP. To that end, subsection 1(2) of the CSP Regulations defines “authorization for sale” to exclude a list of limited-purpose authorizations.
Amended definition of “authorization for sale”
As reflected in the new CSP Guidance, the CSP Regulations have recently been amended to exclude additional limited-purpose drug authorizations from the definition of “authorization for sale” (preserving the right to later obtain a CSP if an NOC issues for the drug). The additional excluded authorizations are under the following provisions:
- Division 11 of the Food and Drug Regulations, which allows public health officials to apply to the Minister of Health to purchase unauthorized drugs to address a potential (or actual) public or military health emergency;
- Subsection C.10.008(1) of the Food and Drug Regulations, for the sale of a drug imported into Canada to address an urgent public health need, including a drug shortage; and
- Section 21 or subsection 24(2) of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations, to authorize a COVID-19 drug for the purpose of a clinical trial.
Current administrative practices
The CSP Guidance, last revised in early January 2021, also has changes to reflect Health Canada’s current administrative practices, including:
- Additional language confirming that the “filing date of the submission” is the date that the submission is deemed administratively complete by Health Canada. For Canadian submissions, the filing date is listed in the “CR” date field on the Drug Submission Tracking System – Industry Access; and
- CSP applications and related correspondence are preferably submitted by email, as opposed to other electronic media or paper.
Updated CSP fee
In accordance with subsection 9(1) of the CSP Regulations, the fee for filing an application for a CSP increases each year. The CSP fee as of April 1, 2023 is $10,152 (increased from $9,952).
- Notice: Publication of the Guidance Document: Certificates of Supplementary Protection – Canada.ca
- Certificate of Supplementary Protection Regulations, SOR/2017-165