On September 21, 2017, the Certificate of Supplementary Protection Regulations ("CSP Regulations") came into force, providing for the first time the ability to obtain an extended period of patent protection for human and veterinary drugs in Canada. With the first anniversary of the program quickly approaching, an overview of its implementation may prove useful and highlight key information for the coming years. For an in depth look at the CSP Regulations, we have previously provided a detailed overview available here.
What is a Certificate of Supplementary Protection?
Briefly, a Certificate of Supplementary Protection ("CSP") is a form of sui generis protection for newly approved pharmaceutical products protected by an eligible patent, for a period of up to two years following expiry of the patent. The CSP Regulations were implemented in accordance with Canada's obligations under the Canada-European Union Comprehensive Economic and Trade Agreement ("CETA"), and were intended to align with Europe's existing Supplemental Protection Certificate system.
Under the CSP Regulations, a patent will only be eligible for a CSP if it pertains (i.e. contains a compound claim, product-by-process claim, or use claim covering the medicinal ingredient) to an approved drug which is a "new medicinal ingredient."
Specifically, the newly approved medicinal ingredient must not be a variant of a previously approved medicinal ingredient. For the purposes of the CSP Regulations, an ineligible variant is:
(a) a variation in any appendage within the molecular structure of a medicinal ingredient that causes it to be an ester, salt, complex, chelate, clathrate or any non-covalent derivative;
(b) a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient;
(c) a variation that is a solvate or polymorph of a medicinal ingredient;
(d) an in vivo or in vitro post-translational modification of a medicinal ingredient; and
(e) any combination of the variations set out in paragraphs (a) to (d).
In addition to the requirements of the medicinal ingredient, there are certain timing requirements that must be met for a patent to be eligible for a CSP:
- the NDS in Canada must have been filed within 12 months (or during the transition period, 24 months) of the earliest regulatory filing in any of: the European Union and any member countries; the United States of America; Australia; Switzerland; and Japan; and
- the CSP Application must be filed within:
- 120 days from NOC issuance where the patent granted on or before the day the NOC issued; or
- 120 days from patent grant where the patent granted after the NOC issued.
If issued, CSPs provide the same protections as the associated patent, with the exception of not preventing exportation, and are eligible to be listed on the Patent Register if the associated patent is also listed.
CSPs in the first year
In its first year, a total of 19 CSP applications have been filed: 18 for human drugs and 1 for veterinary drugs. Health Canada maintains a CSP Register which provides relevant information including the CSP Number, Patent Number, the medicinal ingredient, and the term of the CSP.
Of the 19 CSP Applications, 13 have resulted in Issued CSPs, 3 remain pending, and 3 have been refused. Unfortunately, Health Canada does not publish its reasons for why a CSP Application was refused. However, the refusal of CSP Application 90006, for the medicinal ingredient varicella-zoster virus glycoprotein E (gE), is currently the subject of a Judicial Review with the Notice of Application filed on August 31, 2018. This appears to be the first Judicial Review under the new CSP Regulations, and it will be of interest to see how the Court approaches the review of Health Canada's decision.
Under the CSP Regulations, a CSP is granted for a maximum term of two years, subject to any reduction by the Minister. To date, of the 13 issued CSPs only a single CSP (CSP Number 900010) was granted a term of less than two years. However, this term appears to be the result of the CSP term calculation, not a reduction by the Minister. The CSP Regulations and related Guidance Document are silent on what factors the Minister will consider if she is to reduce a CSP term, and it remains to be seen how any term reductions will be handled by the Minister. Given that Health Canada does not publish reasons for refusals of CSP applications, it is unlikely that Health Canada will publish reasons for reducing a CSPs term.
Potential changes in the years to come
Following the one year anniversary of enactment (i.e., as of September 22, 2018), a company will no longer be able to rely on the transitional provisions within the CSP Regulations. Notably, while currently the Canadian NDS must be filed within the transitional period of 24 months from filing in any of the specified countries, as of September 22, 2018, that period is halved to only 12 months.
It remains to be seen if companies have had sufficient time to align their international regulatory filing strategies to ensure filing in Canada occurs within 12 months of other key jurisdictions. If not, we can expect to see a reduction in the number of CSP Applications issued, given that the requirements have been made more stringent.
Finally, an additional factor to monitor is any potential impact of Brexit. Currently, regulatory filings in Britain are contemplated as a member country of the EU, and therefore count towards the 12-month deadline to file the NDS in Canada. Following Brexit this may no longer be the case, and it remains to be seen if Britain will be added as a specified country under the CSP Regulations. As with many Brexit related issues, it is still too soon to tell.
The first year of the CSP Regulations was quite busy, with 19 CSP Applications filed and 13 issued. As the transitional provisions expire, companies should ensure that their international regulatory portfolio is harmonized, allowing the Canadian NDS to be filed within 12-months of the first worldwide filing to ensure they can take advantage of the additional two years of CSP protection. While harmonizing international regulatory filings can be a significant undertaking, the benefit of a potential two years of further market exclusivity on top of the existing patent portfolio should make it worth the effort.