Canada: Case Summary For Pfizer v Canada (2014 FC 1243, 2016 FCA 248)

Last Updated: July 5 2017
Article by Adam Bobker and Shuo Xing

The Federal Court of Appeal decision in Pfizer v. Canada (2016 FCA 248) upheld the Minister of Health's interpretation that the 24-month stay for patent owners provided for in the PM (NOC) regulations was not available when two (2) companies sought permission (an NOC) to market generic drugs that had already been shown to be as safe and effective as patented drugs. On June 22, 2017, the Supreme Court of Canada denied leave to appeal. Going forward, it is going to be more difficult to seek judicial review of decisions of the Minister of Health under the PM (NOC) regulations if the regulations reasonably support the decision. The Court is not likely to substitute its interpretation unless the Minister's interpretation is seen as unreasonable.

In its 2016 FCA 248 decision the Federal Court of Appeal had reversed an earlier Federal Court decision and held that reasonableness is the correct standard of review to be applied to decisions of the Minister of Health in the context of the PM (NOC) regulations. Applying the reasonableness standard, the FCA upheld the Minister's interpretation of the PM (NOC) Regulations that s. 5 of the Regulations that require patents to be addressed and, thereby, allow for a 24 month stay if prohibition proceedings are taken should not be engaged when a drug submission for notice of compliance (NOC) is purely administrative (eg. name change).

The decision relates to two separate judicial reviews before the Federal Court, both brought by innovator pharmaceutical companies of the Minister's decision to grant NOC's to generic companies for drugs containing active ingredients patented by the innovator companies. On the one hand, Pfizer Inc (Pfizer) sought judicial review over the Minister's decision to grant a NOC to Teva Pharmaceuticals (Teva) for a drug containing the active ingredient exemestane, a breast cancer drug sold and patented by Pfizer in Canada. Initially, a New Drug Submission (NDS) for exemestane was submitted by Generic Medical Partners Inc (GMP) in which GMP referenced Pfizer's patented product and accordingly sent the innovator a Notice of Allegation (NOA) challenging its patent. Pfizer chose not to respond to the NOA since GMP did not sell any product in Canada; thus a NOC was granted to GMP. Teva through a licensing agreement with GMP became the Canadian distributor of the new exemestane product and filed a NDS seeking to change the brand name and the marketer without altering the content of the drug product. A NOC was granted to Teva. In a separate case, Celltrion Healthcare Co Ltd (Celltrion) applied for and obtained a NOC to market its subsequent entry biologic Inflectra, which referenced Janssen Inc (Janssen)'s product infliximab. Because Janssen had not yet received a patent at the time of Celltrion's NDS, no NOA was sent and Celltrion did not address any patent issues. After Janssen's patent covering infliximab was granted, Hopsira filed a NDS and obtained a NOC in the capacity of the Canadian distributor of inflectra as named by Celltrion in its earlier NDS.

In both instances, the Minister's decision to issue NOC to the licensee generic company without requiring the generic company to address the innovator's patent was under review. In analyzing Pfizer's case, after an extensive review of case law pre- and post-Dunsmuir2, the Federal Court established the process to determine the appropriate standard of review. First, one must consider whether the standard of review for the particular issue has been satisfactorily settled in case law. Second, if it has not been settled, the following categories of issues attract a standard of correctness: (1) a constitutional question, (2) a question of general legal importance that is outside of the expertise of the decision-making body, (3) a determination of respective jurisdiction of two decision-making bodies, and (4) a true jurisdictional question. Conversely, if the issue involves a factual or a mixed fact and law determination or if it involves the exercise of a statutorily-conferred discretion or making a policy-based decision that the decision-maker is mandated to make, the standard should be reasonableness. Finally, the Federal court recognized that there is a presumption that the reasonableness standard applies whenever an administrative decision-maker interprets its constituent statute or a statute closely related to its function. However, the Federal Court notes that this presumption can still be rebutted through a contextual analysis using the relevant factors set out in Dunsmuir: existence of a privative clause, nature of the tribunal, nature of question at issue, and expertise of the tribunal2.

Applying this framework to the Pfizer case, the Federal Court had concluded that the appropriate standard of review should be correctness since although the presumption of reasonableness exists in the case of Minister of Health interpreting PM(NOC) Regulations, there is no privative clause in the Regulations, the wording of the Regulations did not afford the Minister any discretion on whether to issue a NOC and the ultimate power whether a NOC should issue resides with the Court. On the standard of correctness, the Federal Court found the Minister's decision to be incorrect since allowing generic companies to not address relevant patents listed against their submissions, the Minister failed to achieve proper balance between the rights of innovators, generic companies and the public, a key purpose of the PMNOC Regulations.

While agreeing with the framework set out by the Federal Court in general, the Federal Court of Appeal arrived at a different conclusion and found that the presumption of reasonableness was not rebutted. According to the Federal Court of Appeal, the fact that PM(NOC) Regulations do not suggest deference does not point away from the reasonableness standard; the proper inquiry following the Supreme Court decision in Tervita should be whether the Regulations evidence Parliament's intent that the decisions of the Minister interpreting the Regulation should be reviewed on a less deferential standard3. Unable to identify any indication to this effect in the PM(NOC) Regulations, the court of appeal concluded that the Minister's interpretations should attract the standard of reasonableness, especially since the statute is very closely related to the Minister's function.

In determining whether the Minister's interpretation was reasonable, the Federal Court of Appeal looked to the Supreme Court decision in Biolyse, in which the Supreme Court interpreted the term "submission" in the then current version of s.5(1.1) of the Regulations by looking to "reciprocal provision" s.4(1) of the Regulations4. In Biolyse, the SCC concluded that submissions should be considered on an individual basis in order to determine whether it is a submission that triggers s. 4 or 5 of the PM(NOC) Regulations. Turning to Hoffmann-La Roche, the court of appeal noted that a NDS should be assessed by asking whether the changes reflected within give rise to a new or different basis for asserting that a particular product is infringing5. Thus, the Minister acted reasonably in deciding that the submissions were purely administrative in nature, did not submit any new data, and did not trigger s.5 procedures.


1 Dunsmuir v New Brunswick, 2008 SCC 9.

2 Ibid.

3 Tervita Corp v Canada (Commissioner of Competition), 2015 SCC 3.

4 Bristol-Myers Squibb Co v Canada (AG), 2005 SCC 26.

5 Hoffmann-La Roche Ltd v Canada (Minister of Health), 2006 FCA 335.

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.

Adam Bobker
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