Canada: One-Year Anniversary Of The CSP Regulations

Last Updated: September 19 2018
Article by Alexander Camenzind

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.1

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:

  1. 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
  2. the CSP Application must be filed within:

    1. 120 days from NOC issuance where the patent granted on or before the day the NOC issued; or
    2. 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, 2018.2 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.


1 This article was based on the proposed CSP Regulations, and therefore some minor differences exist in comparison to the CSP Regulations as they came into force.

2 See Federal Court File No. T-1603-18

Read the original article on

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Similar Articles
Relevancy Powered by MondaqAI
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions