September 2022 marks the fifth-year anniversary of Canada's Certificate of Supplementary Protection regime. It also coincidentally marked the filing of the 100th CSP application. With these milestones having been reached, it's worth investigating just how CSPs are being utilized in Canada.
Number of applications
- 101 applications have been filed, with all but five applications being for human drugs.
- 75 CSPs have issued, with only 13 applications having been refused by the Minister (the remainder being pending or withdrawn).
- Where a final decision was made, a CSP has issued 85% of the time.
- Monoclonal antibodies and small molecule inhibitors lead the way for the most common medicinal ingredient type, with 22 and 23 applications each.
- 16 applications were directed to combination drugs, having more than one medicinal ingredient.
CSP terms
- Two CSPs are currently in force (CSP 900076 and CSP 900087).
- While many CSPs obtain the full two years of protection, the shortest CSP has a term of only 27 days (CSP 900088).
- The CSP with the latest starting date for its term is CP 900079, which doesn't begin until December 2035.
- Health Canada's service standard for a decision is 60 days, however its statistics indicate an initial decision (issuance, or preliminary rejection) is commonly given in 20 days (after waiting the full 120-days from NOC issuance).
Court challenges
- There have been a number of judicial reviews for refusals of a CSP, all of which remitted the issue back to Health Canada.1 In many instances, the application was again refused by Health Canada on reconsideration.
- Despite the CSP Regulations creating a unique provision for addressing "conflicts" between multiple CSP applications, none have taken place so far. There are only two instances where multiple CSP applications were filed for a single NDS, with one of the applications being withdrawn in each instance. The full scope of how a "conflict" is to be addressed remains unclear.
- No Court proceedings have independently assessed the validity of a CSP. It remains unclear if a Court will be tasked with considering a challenge to a CSP's validity on a basis other than the invalidity of the underlying patent.
Overall, with just over 100 applications so far, CSPs have received strong uptake in Canada. Given a CSP can only issue if there is prompt filing of the Canadian regulatory application, this uptake in CSPs suggests an improvement in the overall alignment of global regulatory filings, and the resulting prompt introduction of new drugs into Canada.
With many CSP terms being a few years away, there has been no true challenge to a CSPs term. As those dates draw near, and the associated medicines move beyond their data protection period, it remains to be seen how a Court handles the validity of a CSP, and if they will entertain any request to effectively "second guess" the Minister's decision to issue the CSP.
Footnote
1 See our 3 articles: 1. Better together – Federal court supports broader interpretation of CSP regulations based upon a purposive review of CETA 2. Strike 2: Health Canada's narrow interpretation of the CSP regulations rejected once again 3. Strike three: Federal court finds that Health Canada failed to consider context and purpose of the CSP regime
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