Canada: Pharma In Brief - Federal Court Of Appeal Confirms Single Standard Of Review And Clarifies Rules For Discovery Of Non-Party Inventors

Case: Hospira Healthcare Corporation v Kennedy Institute of Rheumatology, 2016 FCA 215 (Court File No. A 303 15, on appeal from T-396-13)

Drug: Unidentified

Nature of case: Motion for further discovery of non-party inventors in an action for patent infringement/impeachment under the Patent Act, RSC 1985, c P-4

Successful party: The Kennedy Institute of Rheumatology, Janssen Biotech, Inc., Janssen Inc., and Cilag GmbH International (the Respondents)

Date of decision: August 31, 2016


Hospira Healthcare Corporation, together with Celltrion Healthcare Co., Ltd. and Celltrion, Inc. (collectively, the Appellants) are involved in a patent infringement/impeachment action against the Respondents concerning an unidentified "proposed product" belonging to Hospira. This appeal arises from the Appellants' motion for further discovery of the two non-party inventors of the patent in suit, which was successful in part. The judgment is significant because the Respondents asked the Court of Appeal to unify the standard of review for appeals from discretionary orders of prothonotaries and the court, for the first time in 23 years, sat in a panel of five judges to decide the issue.

The court dismissed the appeal, affirming the prothonotary's decision to allow an additional half-day of discovery. In doing so, it clarified the considerations applicable to third-party discovery of inventors and held that all appeals from discretionary decisions of both prothonotaries and motions judges should be subject to the standard of review set out in the Supreme Court's decision in Housen v Nikolaisen, 2002 SCC 33 (Housen).


This dispute concerns Canadian Patent No. 2,261,630, "Anti-TNF Antibodies and Methotrexate in the Treatment of Autoimmune Disease." The Appellants sought discovery of the inventors, who are retired and reside in the United Kingdom, as assignors. A first day of in-person discovery was completed. The Respondents refused to make the inventors available for a second day of in-person discovery and the Appellants moved before the case-management prothonotary, Milczynski P, for an order to this effect. They were awarded a half-day of discovery by teleconference instead. Mr. Justice Boswell dismissed the Appellants' Rule 51 appeal to the Federal Court, giving rise to the further appeal reported here.

The issue of standard of review arises after uncertainty regarding the application of the test articulated in Canada v Aqua-Gem Investments Ltd., [1993] 2 FC 425 (Aqua-Gem). The continued viability of the Aqua-Gem test has already been addressed by the court in a number of recent judgments, including two this year in favour of uniformly applying the Housen standard to all appeals (reported here and here).

A single standard of review for all appeals

Sitting in a panel of five for the first time since Aqua-Gem, the court unanimously confirmed that there is a single standard of review for all appeals from discretionary orders of prothonotaries and motion judges, including on further appeal to the Court of Appeal: As set out in Housen, factual determinations are reviewable for palpable and overriding errors, while questions of law (and questions of mixed fact and law with an extricable legal principle at issue) are reviewable for correctness. Aqua-Gem is no longer good law.

Writing for the court, Nadon JA held that the standard of review in Aqua-Gem has been overtaken by a significant evolution and rationalization of standards of review in Canadian jurisprudence, fundamentally shifting the parameters of the debate. Notably, this change brings federal jurisprudence in line with recent changes to the standard of review from discretionary decisions of masters in the Ontario courts.

In reaching its conclusion, the court acknowledged confusion in the Federal Court regarding the identification of "questions vital to the final issue of the case," a key feature of the Aqua-Gem test, which triggered de novo review by appeals courts. The court also endorsed the view that "traditional notions of hierarchy" within the federal judiciary should be abandoned in favour of a presumption of fitness that prothonotaries and judges are capable of fulfilling their mandates.

Proportionality and the court's role in discovery of non-party inventors

On the merits, the court found that Boswell J had no reason to interfere with Milczynski P's order awarding an additional half-day of discovery via teleconference. However, it took issue with the way the parties handled their dispute.

The court accepted that it was not the Respondents' call to terminate discovery. However, it also held that it was not entirely the Appellants' call to determine the duration of the examinations. The parties should have sought the assistance of the court when it became clear that they could not agree. Once discovery commenced, the Respondents' only proper recourse was a motion under Rule 243 asking the court to make a determination that the continuance of the examination was oppressive, vexatious, or unnecessary.

The court found that Milczynski P properly considered the circumstances and context before her, including the fact that the inventors are not parties to the action, in crafting her order. The court also noted that since the inventors were located in the United Kingdom and could not be compelled to attend an examination without letters rogatory, there was no error in ordering that examination proceed by way of teleconference. As a result, it dismissed the appeal.


Hospira Healthcare Corporation v Kennedy Institute of Rheumatology, 2016 FCA 215, aff'g 2016 FC 436, aff'g Order of Milczynski P dated April 17, 2015 (unreported)

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

Law around the world

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.

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