Canada: Pharma In Brief - Federal Court Of Appeal Denies Leave To Amend Statement Of Claim And Harmonizes The Standard Of Review For All Appeals

Case: Teva Canada Limited v Gilead Sciences Inc., 2016 FCA 176

Nature of case: Appeal from Orders refusing leave to amend statement of claim

Successful party: Gilead Sciences Inc.

Date of decision: June 10, 2016


The Federal Court of Appeal has dismissed two appeals arising out of two consecutive motions brought by Teva Canada Limited for leave to amend its statement of claim. In doing so, the Federal Court of Appeal found that the standard of review to apply to all civil appeals is the standard of palpable and overriding error articulated by the Supreme Court in Housen v Nikolaisen, 2002 SCC 33.  


In 2012, Teva issued a statement of claim to impeach two patents owned by Gilead Sciences Inc.: Canadian Patent No. 2,261,619 (the 619 Patent) and Canadian Patent No. 2,298,059 (the 059 Patent). The allegations against the 059 Patent have been dropped, and were not at issue on this appeal.

Roughly two years later, Teva sought leave to amend its statement of claim based on information it obtained during examinations for discovery. Teva's proposed amendment alleged that the 619 Patent was fraudulently obtained by misleading the Patent Office and was invalid under subsection 53(1) of the Patent Act.

The Prothonotary dismissed the motion, finding that the proposed amendments lacked particularity, but allowed Teva to bring a second motion for further and better particulars.

The second time around, Teva used answers given during discovery to argue that Gilead had not made the class of compounds claimed in the 619 Patent and did not believe it could predict utility across the class. Teva argued that Gilead had made a material misrepresentation to the Patent Office by filing the 619 Patent without a factual basis to prove or soundly predict utility.

On November 3, 2014, the Federal Court dismissed the motion, finding that the proposed amendment was not supported by the evidence and had no reasonable prospect of success.

Within two weeks of the Federal Court's order, relying on the same discovery evidence used in the first motion, Teva brought a second motion for leave to amend its statement of claim. Teva alleged that the 619 Patent was invalid because the specification did not disclose the invention "as contemplated by the inventor", contrary to subsection 27(3) of the Patent Act.

On January 19, 2015, the same Federal Court judge dismissed Teva's second motion for substantially the same reasons as the first motion. He also ruled that if he allowed the amendments, he would effectively be sitting on appeal from his earlier order. Teva appealed both decisions to the Federal Court of Appeal.  

Standard of review

Relying on its own recent jurisprudence, the Federal Court of Appeal found that the standard of review for appeals from all orders is the standard articulated by the Supreme Court in Housen v Nikolaisen, 2002 SCC 33: on questions of law or where a legal principle can be extracted from a question of mixed fact and law, the standard is correctness. Otherwise, the standard of review is one of palpable and overriding error.

The Federal Court of Appeal is trying to homogenize the standard of review for all appeals of orders. Previously, the Federal Court of Appeal would only interfere with discretionary orders of the Federal Court in interlocutory matters where the Federal Court proceeded on a wrong principle, gave insufficient weight to relevant factors, misapprehended the facts or where an obvious injustice would result.  

Teva's appeal dismissed

The Federal Court of Appeal found that the Federal Court did not alter the test for pleading amendments by finding that, for reasons of access to justice, proportionality and efficiency, amendments that do not have a reasonable prospect of success should not be allowed.

The Federal Court of Appeal agreed with the Federal Court that section 53 of the Patent Act raises serious allegations of fraud that require strong supporting evidence, and even with a generous interpretation of the evidence, there was no possibility of relief under section 53 of the Patent Act. Rather, Teva had taken too much from the scientists' statements, which were nothing more than expressions of scientific uncertainty during the inventive process.

Furthermore, Teva had improperly conflated the concepts of inutility and insufficiency under sections 2 and 27(3) of the Patent Act respectively. Whether Gilead could predict the utility of the compounds claimed in the 619 Patent does not equate with whether a skilled person had sufficient information to work the invention.

The Federal Court of Appeal further agreed with the Federal Court that Teva's second motion was an improper relitigation of its first motion that raised essentially the same factual matters. Teva's second motion in effect encouraged the Federal Court judge to sit on appeal of his disposition of the first motion. Both appeals were dismissed with costs. Norton Rose Fulbright Canada LLP successfully represented Gilead in this matter.  

Link to the decision:

Federal Court of Appeal Decision: Teva Canada Limited v Gilead Sciences Inc., 2016 FCA 176

Federal Court Decisions (unreported): Order dated November 3, 2014, Order dated January 19, 2015

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.

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