Canada: Canada Amends Regulations Governing Generic Drug Approval Process

Last Updated: November 23 2006

Article by Anthony Prenol, © 2006, Blake, Cassels & Graydon LLP

Originally published in Blakes Bulletin on Intellectual Property, November 2006

The Canadian government has announced substantial amendments to the Patented Medicines (Notice of Compliance) Regulations (the NOC Regulations) and the Food and Drug Regulations (the FD Regulations) that will significantly alter the nature of litigation between innovator and generic drug companies.


The NOC Regulations were initially implemented by the Canadian government in 1993, at the same time that the government abolished the specific compulsory licensing scheme that had been in place for patented pharmaceuticals for many years and also enacted an early-working exception.

The NOC Regulations link the ability of the Minister of Health (the Minister) to approve the marketing of a generic drug through the issuance of a Notice of Compliance (NOC) with the patent status of the equivalent innovative drug product. More particularly, a generic manufacturer which compares its product with a patented, innovative drug must either await the expiry of the innovator’s patents before obtaining its NOC or make an allegation of non-infringement or invalidity that is either not disputed by the innovator or is upheld by a court.

If an innovator commences court proceedings for an order prohibiting the Minister from issuing an NOC to a generic manufacturer (NOC proceedings or prohibition proceedings), the NOC Regulations provide for a stay of up to 24 months, which can be extended or abridged by court order, before the Minister can issue an NOC. The purpose of this stay is to allow sufficient time for the innovator’s prohibition proceeding to be heard by the court.

Since their inception, the NOC Regulations have been the subject of extensive litigation and lobbying by both sides of the pharmaceutical industry and also by public interest groups. While previous amendments to the NOC Regulations brought clarity to certain matters, they also led to more litigation as innovators and generic manufacturers disputed the meaning of various amended provisions.

In making the recent amendments to the NOC Regulations, the Canadian government appears to have a number of goals in mind. First, it is attempting to address concerns that have been raised by innovators and generic manufacturers in recent years regarding certain provisions of the NOC Regulations that each group regards as unfair. Second, it is seeking to effectively reverse interpretations given by the courts to various provisions of the NOC Regulations in circumstances where the government either disagrees with the courts’ interpretation or acknowledges that deficiencies in the drafting of the NOC Regulations were responsible for these rulings. Third, the amendments seek to strike a balance between prevention of patent infringement and facilitation of the entry of generic drugs into the marketplace where no infringement exists.

Patent Register

At the heart of the NOC Regulations is the patent register maintained by the Minister. Generic manufacturers must satisfactorily address patents listed on the register for the equivalent innovative drug before they can obtain an NOC.

Generic manufacturers have long complained that the NOC Regulations permit innovators, when obtaining an NOC for a drug, to list patents on the register that do not bear much, if any, relationship to the drug for which approval is granted by the innovator’s NOC. These patents can then be used by the innovator to delay or prevent a generic manufacturer from obtaining an NOC. Innovators have, in turn, complained that the NOC Regulations unfairly limit the types of patents that can be listed and permit a generic manufacturer to make multiple and frivolous allegations concerning a drug.

Eligible Patents

In response to the innovators’ concerns, the amendments to the NOC Regulations have expanded the types of patents that can be listed on the register. Previously, the only patents that were eligible to be listed on the register were those that contained claims to the medicine itself or to the use of the medicine. As a result of the amendments to the NOC Regulations, a patent is now eligible to be listed in connection with a New Drug Submission (NDS) if it contains one or more claims for: (i) the approved medicinal ingredient; (ii) the approved formulation containing that medicinal ingredient; (iii) the approved dosage form; or (iv) an approved use of the medicinal ingredient.

These amendments are not intended to change the preexisting situation which enables product-by-process patents and patents for biologic drugs and polymorphs to be listed. Patents claiming processes, intermediates or metabolites of the medicinal ingredient remain ineligible for listing.

At the same time that the government is broadening the types of patents that are eligible for listing on the register, it is also placing a limitation on when an eligible patent can be listed. More particularly, the amendments to the NOC Regulations provide that the medicinal ingredient, formulation, dosage form or use claimed in the patent sought to be listed must have been approved through the issuance of an NOC in respect of the NDS in question.

Dosage Form Patents

The Regulatory Impact Analysis Statement (RIAS) that accompanied the amendments to the NOC Regulations explains that the intent behind the inclusion of dosage form patents in the list of eligible patents is to provide protection for novel delivery systems by which the approved medicinal ingredient or a formulation containing that ingredient is administered to the patient. The RIAS gives as examples controlled-release tablets and capsules, implants and transdermal patches. The RIAS also cautions, however, that, to be listed, a patent must include a claim to the specific dosage form described in the NDS and must also contain a claim that includes within its scope the approved medicinal ingredient. Therefore, a patent directed solely to a device, such as an intravenous stand or syringe, would not meet the definition of "dosage form" and hence would remain ineligible for listing.

Eligible Submissions

In the past, there were many cases involving the issue of when a supplemental new drug submission (SNDS) could permit an innovator to list a patent on the register. The amendments provide that, if the innovator has filed a patent application prior to its SNDS, it can submit that patent for inclusion on the register in respect of that SNDS, provided that the purpose of the SNDS is to obtain approval for a change in use of the medicinal ingredient, a change in formulation or a change in dosage form and that the patent contains a claim to the formulation, dosage form or use so changed.

As always, an innovator must submit its patent list either with the specific NDS or SNDS to which its patent relates or within 30 days after the issuance of the patent, provided that the Canadian filing date of its patent application precedes the filing date of its submission.

None of the above amendments apply to patents that were on a patent list submitted to the Minister prior to June 17, 2006.

Frozen Patent Register

One of the most significant complaints by generic manufacturers has been that innovators "evergreen" their patents by listing improvement patents on the register during the pendency of NOC proceedings so as to result in successive 24-month stays.

This concern is addressed in the amendments to the NOC Regulations by requiring a generic manufacturer only to address patents that were listed on the register in respect of the innovative drug as of the filing date of the submission by the generic manufacturer for an NOC. As such, the register is effectively frozen during the pendency of the generic manufacturer’s regulatory submission.

The following transitional provisions apply in respect of the above measures. In the case of submissions filed by generic manufacturers on or after October 5, 2006, the changes apply with full effect. In the case of submissions filed by generic manufacturers prior to October 5, 2006, the date of filing of the generic’s submission is deemed to be October 5, 2006 such that the generic manufacturer will not have to address any patents that are added to the register on or after that date.

Timing Of Generic Manufacturer’s Challenge

A generic manufacturer will no longer be permitted to commence the process for challenging a patent under the NOC Regulations through a notice of allegation until it has filed a submission for an NOC.

Infringement Of Use Patents

The amendments seek to clarify the situation where an innovator asserts a patent with claims to a specific use against a generic manufacturer who has filed a submission for an NOC seeking approval to market the drug for a non-patented use. The amendments and the RIAS clarify that, in the case of use patents, a court should limit its inquiry to whether acts of infringement will occur by or at the behest of the generic manufacturer. In other words, it is not sufficient for the innovator to show that third parties, such as pharmacists, may infringe the innovator’s patent by dispensing the generic product for a patented use. Rather, the innovator will need to establish that it is apparent from an examination of the generic manufacturer’s product monograph and labelling that it intends to market the drug for a patented indication.

Recovery By Generic

Section 8 of the NOC Regulations enables a generic manufacturer to obtain recovery for losses that it suffers as a result of a prohibition proceeding commenced by an innovator where the prohibition proceeding was withdrawn or discontinued by the innovator or dismissed by a court.

Although no case on section 8 has yet gone to trial, there has been a series of interlocutory skirmishes over whether subsection 8(4) permits a court to award a generic manufacturer an election of either its damages or the innovator’s profits. Subsection 8(4) formerly read "The court may make such order for relief by way of damages or profits as the circumstances require in respect of any loss referred to in subsection (1)".

The amendments to the NOC Regulations now provide that the court can only make an award of damages to a successful generic manufacturer. This amendment will not, however, apply to any action commenced under section 8 prior to the coming into force of the amended regulations on October 5, 2006. In the RIAS, the government notes that it is reserving comment on the proper interpretation of the word "profits" in the former subsection 8(4), presumably since it does not wish to influence the outcome of litigation between innovators and generic manufacturers on this very issue. The amendments also provide that the Minister is not liable for any damages under section 8, a revision that was presumably made in response to an attempt by an innovator in one section 8 case to visit part of its liability under this section on the Minister for its delay in processing the generic manufacturer’s submission for an NOC.

Data Protection

The amendments to the FD Regulations prohibit the Minister from issuing an NOC to a manufacturer that makes a direct or indirect comparison to an "innovative drug" until at least eight years have passed from issuance of the innovator’s NOC for the innovative drug.

The amendments are important because generic manufacturers generally obtain drug approvals by making "abbreviated" drug submissions that establish the generic drug’s bioequivalence with an existing "reference product". The amendments prevent the use of the innovator’s data during the restricted period. Until now, Canada provided a five-year period of data protection. However, the Federal Court of Appeal has held that this protection period does not prevent generic manufacturers from relying on an innovative product in an abbreviated drug submission.

The Federal Court of Appeal’s interpretations effectively reduced the market exclusivity available in Canada below the levels required by international agreements. Canada is a party to the World Trade Organization’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the North American Free Trade Agreement. Those agreements require that member states afford a minimum of five years of market exclusivity. By way of comparison, the United States provides five years of data protection with the possibility of a three-year extension for new therapeutic indications or significant changes based on new data and a further six-month extension for pediatric data. Europe provides 10 years of data protection with the possibility of a one-year extension for a new therapeutic indication.

This new eight-year Canadian period is extended by a further six months in the case of drugs that have been the subject of clinical trials designed and conducted for the purpose of increasing the knowledge of the behaviour of the drug in pediatric populations. "Innovative drug" is defined as "a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph".

Additionally, the amendments have introduced a six-year "no filing" period within the eight-year term of data protection. An exception to this six-year period allows for the filing of drug submissions within the framework of Canada’s Jean Chretien Pledge to Africa Act for the export of certain medicines to Africa. These drug submissions can be submitted within the no filing period. However, an NOC will not be issued until the expiry of the eight-year data protection term.

The six-year and eight-year prohibitions do not apply where the innovator consents to the earlier filing by a second manufacturer of an application for an NOC or to the issuance of an NOC to a second manufacturer, as the case may be.

Under the amendments to the FD Regulations, data protection will only apply where the innovative drug has received an NOC and is marketed in Canada. A register of innovative drugs will also be created, listing for each such drug the dates on which the six-year, eight-year and, where applicable, the pediatric extension periods will expire.

These data protection provisions are not applicable to a drug in respect of which an NOC was issued before June 17, 2006.


The amendments provide some much-needed clarification and improvement to both sets of Regulations. If past experience is any guide, however, we can expect a flood of litigation on the interpretation of at least some of the amendments together with calls for further amendments.

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.

Events from this Firm
26 Oct 2018, Other, Vancouver, Canada

Cybersecurity, including data privacy and security obligations, has become a critical chapter in every company’s risk management playbook.

30 Oct 2018, Other, Toronto, Canada

Please join us for discussions on recent updates and legal developments in pension and employee benefits as well as employment law issues.

12 Nov 2018, Other, Toronto, Canada

Stories aren’t falsehoods. Stories are the root of all effective human communications: they motivate, animate and clarify. If you aren’t telling stories, you probably aren’t getting your point across.

In association with
Related Topics
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