Canada: Pharma In Brief - Federal Court Dismisses Apotex's Application For Judicial Review Of Health Canada Decision Rejecting ANDS For Apo-Progesterone

Case: Apotex Inc v Minister of Health, 2017 FC 127 (Court File No. T-1516-16)

Drug: Apo-Progesterone (referencing PROMETRIUM® )

Nature of case: Judicial review of minister's refusal to issue Abbreviated New Drug Submission (ANDS) to Apotex.

Successful party: Minister of Health

Date of decision: February 1, 2017

Summary

Health Canada rejected Apotex's ANDS for a generic version of PROMETRIUM® (progesterone) due to high levels of sodium lauryl sulfate (SLS). Apotex applied for judicial review of the decision on grounds of procedural fairness and substantive unreasonableness. The court dismissed Apotex's application.

Background

Apo-Progesterone contains levels of SLS that Health Canada found to be unusually high. Apotex recognized that the amount of SLS would be an issue for Health Canada and provided information regarding US Food and Drug Administration (FDA) approval of a different Apotex product containing even higher levels of SLS and other evidence relating to the toxicology of SLS.

Health Canada engaged in a series of communications with Apotex and ultimately denied the ANDS. Apotex filed a request for reconsideration, and a panel concluded there was insufficient evidence to support allowing an increased limit of SLS. The panel determined that the evidence relating to the toxicology of SDS, including the evidence put forward by Apotex, was of "low quality," incomplete, sometimes unpublished, and did not comply with Good Laboratory Practice. The panel also concluded that the FDA approval was not sufficient to support Apotex's contention that its SLS levels for Apo-Progesterone were safe and effective as the claim was missing documentation and excipient levels are not approved in Canada based solely on the fact that such levels had been approved by foreign regulatory agencies. The panel report was ultimately accepted by Health Canada, and the ANDS was again denied.

Apotex subsequently attempted to obtain another reconsideration, including by Apotex's CEO directly contacting the director general of the Therapeutic Products Directorate. The request for reconsideration was denied, and Apotex applied for judicial review.

Apotex's application for judicial review

Justice Phelan dismissed the application, holding that Apotex was afforded a fair procedure and the decision was reasonable.

Apotex's delay. The minister argued that Apotex had failed to bring the application for judicial review within the 30-day time limit.

In the application, Apotex "suggested that it was somehow led on" by the director general to think that the second reconsideration might occur and implied that Health Canada was "somehow antagonistic" to Apotex based on two recent judgments of Justice Manson (reported here). Justice Phelan held that this was "an unfair and unreasonable interpretation" of the director general's words and actions, the two decisions were irrelevant, and the decisions and the record in the application did not establish such antagonism. He found that at best Apotex's CEO had an "honest but mistaken belief" that his request for a second reconsideration would be accepted and characterized Apotex's suggestion as a "desperate plea" to excuse Apotex's failure to file its application on time.

Justice Phelan did note that if Apotex had filed for judicial review the reconsideration would end, there had been a continued intention to dispute the conclusion, and there was significant public interest in decisions relating to public health. He therefore granted Apotex an extension of time.

Procedural fairness. Apotex argued that an external rather than an internal panel should have been used, the panel had demonstrated bias by circulating a draft memorandum showing a closed mind, the panel did its own research and raised new studies at the hearing depriving Apotex of the opportunity to respond, and the panel made legal conclusions it was not entitled to make.

Justice Phelan ruled against Apotex on all four arguments. He held that the guidelines allowed for an internal panel provided it was independent and impartial, the evidence did not show that the panel had decided the matter before hearing from Apotex, Apotex knew what the issue was and had sufficient opportunity to respond, and it was a mischaracterization of the reasons to state the panel had made legal conclusions.

Decision was reasonable. Apotex argued that the panel failed to consider the FDA approval of a different Apotex product containing even higher levels of SLS. Justice Phelan found that throughout the process Health Canada had "continually raised the issue of the SLS levels and offered multiple opportunities for Apotex to provide evidence to establish that high levels of SLS could be accepted," including seeking details of the FDA approval. Further, Health Canada had made it clear that approval was not based solely on the fact that a foreign regulatory agency had accepted higher levels of SLS. He found nothing unreasonable in the panel's decision that Apotex had not justified its reliance on the FDA approval.

Link:

Apotex Inc v Minister of Health, 2017 FC 127.


About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's preeminent corporations and financial institutions with a full business law service. We have 3800 lawyers and other legal staff based in more than 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

For more information about Norton Rose Fulbright, see nortonrosefulbright.com/legal-notices.

Law around the world
nortonrosefulbright.com

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 Mondaq.com.

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

Authors
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
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
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

Mondaq.com (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 www.mondaq.com

To Use Mondaq.com 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.

Disclaimer

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.

General

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