Canada: Certificates Of Supplementary Protection: Canada's New Sui Generis Patent Term Restoration Regime

We previously reported on Bill C-30 (the "Act to implement CETA") which made important changes to Canada's intellectual property landscape reflecting its commitments under the Comprehensive Economic and Trade Agreement between Canada and the European Union ("CETA"). That bill passed on May 16, 2017, and, on July 14, 2017, the Canadian Government published proposed amendments to regulations reflecting these changes (the "Proposed Regulations").

This article focuses on proposed amendments to the Patent Rules relating to Certificates of Supplemental Protection ("CSP"), a sui generis version of patent term restoration which will be available once the Act to implement CETA comes into force (which is provisionally set to occur on September 21, 2017 - see here). CSPs are intended to address lost patent protection due to delays related to fulfilling regulatory requirements and obtaining marketing approvals for a pharmaceutical product encompassed by that patent.

The Proposed Regulations are open to public consultation for 15 days following their publication. Comments must thus be submitted by Sunday, July 30th.

Key takeaways

  • CSPs are available in connection with a "first authorization for sale" of a product containing a "medicinal ingredient" or "combination of medicinal ingredients". This requirement cannot be circumvented by making certain prescribed changes to the medicinal ingredient (eg. enantiomer, solvate, etc) or combination (eg. the ratio of ingredients), which are treated as the same as that of the authorized product. However, this treatment also prevents circumvention of CSP protection which extends only to drugs containing the medicinal ingredient / combination set out in the CSP.
  • Innovators should review Canadian patent applications to ensure that they include appropriate claims to take advantage of CSP protection. Patents with claims directed to the medicinal ingredient / combination or its use are eligible for a CSP. Claims to the medicinal ingredient / combination made by a specific process are also acceptable. However, process claims or claims to formulations and dosages are not eligible.
  • Innovators should strive, where possible, to ensure that Canadian drug submissions are filed shortly after foreign filings and diligently pursued thereafter. The CSP regime emphasizes timeliness to ensure new drugs are introduced quickly into Canada. A first Canadian authorization for a product will thus be eligible only if filed within one year (or 18 months for CSP applications filed within the first year of the legislation coming into force) of equivalent filings in certain foreign jurisdictions, including the United States and the European Union. The Minister is also granted discretion to reduce the term of the CSP due to delays during the process of obtaining an authorization. No guidance is provided yet as to how this discretion will be exercised.
  • CSPs will be available only for products for which a first authorization is issued after the legislation comes into force (anticipated to be in September 2017, per above).
  • Subject to priority rules for CSP applications, innovators are at liberty to select for which eligible patent it will seek a CSP. Factors to consider would include the anticipated term for each patent and the nature of the claims of the patent.

Eligibility for a CSP

CSPs will not be available for all patents. Briefly, CSPs are intended to extend protection for a single patent in connection with the first "authorization for sale" of a product containing a "medicinal ingredient" or a "combination of medicinal ingredients" to which that patent "pertains". We summarize below key aspects of the eligibility requirements for a CSP.

(a) Single CSP per "Medicinal Ingredient" or "Combination of Medicinal Ingredients"

CSPs pertain to a specific "medicinal ingredient" or "combination of medicinal ingredients." The Act to implement CETA provides that a CSP will only issue if no other CSP has been issued with respect to that medicinal ingredient / combination. This bar applies even where the other CSP is subsequently held to be invalid or void, or it never takes effect or ceases to have effect.

Further narrowing the availability of a CSP, "medicinal ingredients" which differ only with respect to "prescribed variations" as the "same medicinal ingredients" are treated as the same. The Proposed Regulations provide further guidance concerning the prescribed variations to "medicinal ingredients", defining them as follows:

  • 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 derivative1;
  • a variation that is an enantiomer, or a mixture of enantiomers, of a medicinal ingredient;
  • a variation that is a solvate or polymorph of a medicinal ingredient;
  • an in vivo or in vitro post-translational modification of a medicinal ingredient; and
  • any combination of the variations set out above.

The RIAS also indicates the above-noted kinds of variations apply to medicinal ingredients within a combination. That is, a combination of medicinal ingredients which comprises ingredients which are treated as the same (ie. prescribed variations, per above) as the ingredients in another combination will be treated as the same combination.

The Act to implement CETA also contemplates that "combinations of medicinal ingredients" which differ only with respect to "a variation in the ratio between those ingredients" are to be treated as the same combinations.

Notably, the new CSP regime appears to allow a CSP for a new combination product despite the issuance of a CSP in connection with a product comprising one of the medicinal ingredients in that combination. For example, CSPs relating to authorization for Product A (containing only medicinal ingredient X) and Product B (containing only medicinal ingredient Y) would not prevent a CSP for authorization for Product C (containing the combination of medicinal ingredients X and Y).

(b) CSP Available Only for First Authorization for Sale

A CSP may only be obtained for the "first authorization for sale" that has been issued with respect to the medicinal ingredient / combination. The Proposed Regulations clarify that such authorization is one under the Food and Drugs Act (or predecessor legislation) that permits the sale of a drug in Canada  (practically, this is a Notice of Compliance or NOC), except for certain specified limited purpose authorizations and interim orders permitting the sale of a drug.

Consistent with the above example about overlapping CSPs, the new CSP regime appears to allow an applicant to obtain a CSP for a new combination product despite authorizations for sale having previously issued for single-ingredient products containing each of the same medicinal ingredients. The RIAS in fact states that "to be eligible, the medicinal ingredient or combination cannot have been the sole medicinal ingredient or the combination of all medicinal ingredients in a drug previously authorized for regular sale in Canada."

(c) CSP Available only for Authorizations for Sale after the Legislation comes into Force

CSPS will only be available in connection with authorizations for sale (eg. a NOC) issued on or after the day on which the legislation comes into force. As noted above, this is currently anticipated to occur in late September 2017. Patentees, or applicants for drug submissions, should thus carefully review their portfolio of drug submissions in Canada in the next few months to consider an application for a CSP can be made.

(d)  Patent must "Pertain" to the Medicinal Ingredient / or Combination

Only patents which "pertain" to a medicinal ingredient / combination are eligible for a CSP. The Proposed Regulations prescribe this pertinence as a patent claim for:

  • the medicinal ingredient / combination contained in a drug for which the authorization for sale was issued;
  • the medicinal ingredient / combination as obtained by a specified process and contained in a drug for which the authorization for sale was issued; or
  • a use of the medicinal ingredient / combination contained in a drug for which the authorization for sale was issued.

A CSP thus cannot be obtained for a dosage form or formulation, or claims directed exclusively to processes for making a medicinal ingredient / combination. The Proposed Regulations also specify that, for combinations, only patents which contain the above-noted claims relating to "all the medicinal ingredients" in the authorization for sale will satisfy the pertinence requirement.

(e)  Applications for an Authorization for Sale Must be Timely Filed

The Act to implement CETA requires that, to be eligible for a CSP, an application for authorization for sale be filed within a prescribed time from filing an equivalent application for the same medicinal ingredient / combination in other countries. The RIAS describes this as the timely submission requirement, which is intended to incentivize the early introduction of innovative drugs into the Canadian market.

The Proposed Regulations limits this requirement to the following countries: European Union (and any country member of it), the USA, Australia, Switzerland and Japan.

More importantly, the Proposed Regulations specify that the Canadian submission must be filed within only 12 months of the filing of the equivalent submissions in those countries. This is extended to 18 months for CSP application filed during the first year the CSP regime comes into force.

Formally, an applicant for a CSP will be required to include in its application an attestation that either it has not filed for an authorization in these countries or, if it has, the application in Canada was filed before the end of the above-noted period.

Supplemental protection for up to 2 years

CSPs will last for at most two years. Subject to that cap, the term is calculated by subtracting five years from the period beginning on the filing date of the patent and ending on the approval date of the drug. For example, if an applicant files a patent on January 1, 2013 and obtains an authorization for a product to which that patent pertains on January 1, 2019, the default term of the CSP would be 1 year (2019 – 2013 – 5 = 1 year), assuming the eligibility requirements are satisfied.

The Act to implement CETA however gives the Minister the discretion to reduce this term. The Minister may do so if he or she is of the opinion that the person who obtained the authorization for sale failed to act, resulting in a "period of unjustified delay in the process of obtaining the authorization". In such case, the term can be reduced "by the amount of that period". This discretion only applies, however, if the person who obtained the authorization is also the patentee.

The Proposed Regulations provide no further guidance on how the Minister is to exercise this discretion. There is thus uncertainty about when the Minister will do so and what factors the Minister will consider in determining whether a delay has occurred. For example, this discretion appears limited to delays in the process of obtaining an authorization, that is, after the submission for that authorization has been filed in Canada. This is particularly the case given that the CSP regime permits, as noted above, an acceptable (and "timely") period for filing in Canada after filing in other jurisdictions.

Competing applications for CSPS

Where there are multiple eligible patents, patentees may choose in respect of which patent it wishes to seek a CSP.

The Act to implement CETA however sets out priority rules and challenge mechanisms for determining which CSP application ought to issue when there are multiple eligible applications in respect of the same authorization for sale. No conflicts can arise for applications in respect of different authorizations because either (1) they will relate to sufficiently different products to each be potentially eligible for a CSP, or (2) one of the applications will not satisfy the "first authorization for sale" requirement.

CSP applications with patents issued before the authorization have equal priority as between each other, and greater priority than those with patents issued after the authorization. As between applications with patents issued after the authorization, the date the patents issued determines their priority. Applications for a CSP with a lower priority patent then simply expire when a higher priority CSP issues.

Potential conflicts thus only arise where there are multiple applications with equal priority for CSPs relating to the same authorization. The Proposed Regulations encourage non-judicial resolution of these conflicts by requiring the Minister to provide notice to the applicant(s) of conflicting applications and by permitting applicants to withdraw one or more applications for a CSP.

Applicants may however commence a proceeding in the Federal Court within 90 days of receiving notice of the conflict from the Minister. In such proceeding, the applicant seeks a declaration that the other pending application is invalid for non-compliance with the eligibility requirements for a CSP. Unfortunately, neither the Act to implement CETA, the Proposed Regulations nor the RIAS set out how such applications become non-compliant. The CSP regime thus provides no guidance to the Federal Court as to how to resolve such conflicts.

Reduced scope of sui generis protection

The Act to implement CETA limits the protection afforded by the CSP to "any drug that contains the medicinal ingredient, or combination of medicinal ingredients" set out in the CSP, rather than the full scope of protection of the patent itself. CSP protection should nonetheless extend to different formulations or dosage forms of drugs containing those same medicinal ingredients / combinations, where the underlying patent claims support such extension. In addition, CSP protection also does not extend to exports.

Holders of CSPs should however benefit from the CSP regime's treatment of medicinal ingredients / combinations with the above-noted prescribed variations as the same (including in defining the scope of protection) may make it easier to establish infringement. Indeed, the RIAS expressly states that this treatment is intended to ensure that such variations cannot be used to circumvent the scope of protection granted by an issued CSP.

Administrative matters

The Proposed Regulations also clarify several procedural matters. For example:

  • Deadline to apply for a CSP: Applicants will have 120 days from the issuance of an authorization (if the patent has already issued) or otherwise from the grant of the patent. However, no applications for a CSP will be permitted during the two years before patent expiry.
  • Consent by Patent Owner: The Applicant must also include in its application an attestation that either it is (1) the patentee and is recorded as an owner of the patent in the Patent Office or (2) the manufacturer who is authorized by the patentee to file the application. Only the recorded owner of the patent may authorize a manufacturer to file an application for a CSP on its behalf. Patentees will thus want to ensure that a patent's ownership details are properly updated and that this is done on a timely basis.
  • Cost of a CSP: The currently prescribed fee for a CSP is $9,011CAD. It will however begin increasing annually at a rate of 2% starting on April 18, 2018.
  • Correction of obvious errors: The RIAS expressly states that the validity of a CSP should not be jeopardized by clerical errors. The Proposed Regulations permit the Minister to correct obvious errors, including obvious omissions, in an application or CSP in appropriate circumstances. A corrected application or CSP has the same effect as if it were originally filed or issued in its corrected form.


1 The Regulatory Impact Statement which accompanied the Proposed Regulations (the "RIAS") describes "an appendage" as a portion of the molecule that is connected or joined to a larger or more important part, or the non-principal part of the molecule which is not principally responsible for the mechanism of action of the medicinal ingredient

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