Canada: Innovator Delays Its Own Canadian Drug Approval In Effort To Secure Data Protection

On June 12, 2015, at the urgent request of Horizon Pharma PLC ("Horizon"), the Federal Court of Canada granted a rare interlocutory stay preventing the Minister of Health (the "Minister") from issuing a Notice of Compliance ("NOC") to Horizon in respect of its own glycerol phenylbutyrate drug RAVICTI that will be used to treat Urea Cycle Disorders ("UCDs"). Horizon sought the stay to prevent generic competitors from using the information in its regulatory submission while Horizon challenged the Minister's decision to deny RAVICTI data protection. The Minister did not oppose Horizon's motion.

While this case raises a fairly unique issue, the Court's ruling in respect of irreparable harm may have broader implications in terms of the ability to obtain interlocutory injunctions (TROs) in Canadian pharmaceutical patent litigation. In this case, the Court linked the recovery of Horizon's R&D investment to the period of exclusivity Horizon would enjoy should data protection ultimately apply. The risk associated with the inability of Horizon recouping its investment in that specific time period was held to be irreparable harm.

This finding may have broader implications, for example, in the context of pharmaceutical patent litigation where innovators are often entitled to a period of market exclusivity as a result of patent protection. In such instances, the grant of a generic NOC before the expiry of a relevant patent might make it impossible for an innovator to recoup its R&D investment during the period of exclusivity it would have otherwise enjoyed as a result of its patent protection. This is especially so if and where patent infringement damages may be limited or reduced. Accordingly, a stay of the Minister's decision to grant a generic NOC might be appropriate in certain circumstances, for example, where an innovator is seeking to appeal from an invalidity judgment in the context of the PM(NOC) Regulations and might be unable to fully recoup its R&D investment in the form of damages for patent infringement.

Background of this Case

Canada's Food and Drug Regulations protect pharmaceutical innovators who submit undisclosed data to the Minister in support of regulatory approval to market their drugs in Canada. These regulations prevent generic competitors from using the innovator's data to support their own drug submissions for a defined period. This is so even when no patent protection exists. Innovators are not granted the protection by default, but rather it is obtained at the discretion of the Minister, who determines inter alia, whether the drug is an "innovative drug" as defined by the regulations, namely whether it:

  1. contains "a medicinal ingredient not previously approved in a drug by the Minister"; and
  2. is not "a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph".

Horizon was notified that its RAVICTI product was ineligible for data protection as it was considered an ester variation of another drug (PHEBURANE (sodium phenylbutyrate)) and in the alternative, was a "second minor variation" of phenylbutyric acid, which was approved in PHEBURANE as a sodium salt. Horizon sought judicial review of the Minister's decision on May 20, 2015, and to allow time for that application to be decided, sought the stay to prevent generic access to the data filed for its RAVICTI submission.

In considering the request for a stay, the Court applied the test recognized in RJR-MacDonald Inc v Canada (Attorney General), [1994] 1 SCR 311, which requires an applicant to demonstrate:

  1. a serious issue to be tried;
  2. irreparable harm if no stay is granted; and
  3. the balance of convenience favouring the requested relief.

Serious Issue to be Tried

While reiterating that the threshold to find a "serious issue" is low, the Court still considered the merits of Horizon's contentions, including that the Minister misinterpreted and misapplied the definition of "variation" for an "innovative drug" (noted above). The Court was satisfied that there was a serious issued to be tried.

Irreparable Harm

To demonstrate irreparable harm, and on the basis of affidavit evidence, Horizon presented two categories of harm, namely non-compensable harm to Horizon, and irreparable harm to patients requiring the drug at issue.

With regard to the first category, Horizon argued that should the stay not be granted, it would withdraw its drug submission and refuse to market RAVICTI in Canada, thereby losing profits that would be unrecoverable by other means. The Court agreed that Horizon would not be able to recoup its sunk investment costs should its market become genericized so quickly, in the absence of data protection. The Court was satisfied this alone was sufficient to demonstrate irreparable harm.

In other words, the Court held that the inability to recoup R&D investment costs with respect to the drug was irreparable harm. The Court did not go any further in its reasons and did not consider, for example, what (if any) impact the inability to recoup its investment might have on Horizon. Nor did the Court consider relevant whether Horizon would have been able to recoup its investment through future sales, even in the face of generic competition. Clearly, the Court linked the recovery of investment to the period of exclusivity Horizon would enjoy should data protection ultimately apply.

With regard to the second category—harm to patients—the Court considered whether third party harm could be used to demonstrate irreparable harm, but opted not to determine the issue based on the fact that irreparable harm had already been demonstrated by the non-compensable harm faced by Horizon itself.

Balance of Convenience

In finding that the balance of convenience favoured granting the stay, the Court referred to the public interest, noting that patients with UCDs would have access to what could be a life-saving drug should the stay be granted and Horizon not withdraw from the Canadian market. The Court also reinforced its position by noting the Minister's lack of objection to Horizon's motion for the stay.

The case is published as Horizon Pharma PLC v Minister of Health et al, 2015 FC 744.

To view original article, please click here.

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