Canada: New Developments On The Patent "Utility" Debate In Canada


There have been a number of notable developments in recent weeks in respect of patent utility law in Canada.

On October 30, 2014, the Federal Court of Appeal upheld prohibition orders against Mylan Pharmaceuticals ULC and Apotex Inc. (the Appellants) with respect to the drug CELEBREX® (celecoxib). This decision provides further guidance on assessing a "promise" of patent utility by holding that a "promise" must be explicitly and unambiguously made and may be construed on a claim-by-claim basis.

In another development, while issues of patent utility were expected to be addressed by the Supreme Court of Canada in Apotex Inc. et al. v. Sanofi-Aventis et al. (re: PLAVIX®) on November 4, 2014, this case was discontinued by Apotex, on consent, on the eve of hearing.

In the background, Canada's international obligations in respect of patent utility continue to be the subject of debate at the international level, with a challenge by Eli Lilly and Co. against Canada under the North American Free Trade Agreement, Chapter 11 investor-state dispute provisions.

Further information on these recent developments is provided below.

Federal Court of Appeal restates the "promise of utility" doctrine in favour of patent owners

Cases: Apotex Inc. v. Pfizer Canada Inc. et al. and Mylan Pharmaceuticals ULC v. Pfizer Canada Inc. et al.
2014 FCA 250 (celecoxib)

Nature of cases: Appeals of two s.6 prohibition orders pursuant to the PM(NOC) Regulations
Date of decisions: October 30, 2014

Federal Court of Appeal decision in celecoxib

The Federal Court of Appeal heard a consolidated appeal of two decisions of Justice Harrington, cited as 2014 FC 38 (the Mylan Decision) and 2014 FC 314 (the Apotex Decision). Before the Court of Appeal, Apotex advanced four distinct invalidity arguments, namely: (1) lack of utility in treating inflammation in humans; (2) lack of utility in reducing side effects; (3) lack of utility in preventing colorectal cancer; and (4) insufficient disclosure1. Mylan's submissions were directed to the second of these arguments. Mylan argued that because Canadian Patent No. 2,177,576 (the '576 Patent) failed to meet a "promise" of reduced side effects in humans, it was invalid for lack of utility. The 576 Patent's specification stated that "(t)he compounds are useful as anti-inflammatory agents [...] with the additional benefit of having significantly less harmful side effects". The Appellants further contended that the Respondents had conceded in earlier prohibition proceedings against Novopharm Ltd. (the Novopharm Case) that reduced side effects were necessary to establish celecoxib's utility and were now abusing the Court's process by taking a different position.

A "promise" must be "clear and unambiguous"

The Court of Appeal confirmed that the threshold to establish utility is "generally quite low" being no more than a "scintilla of utility" absent an explicit promise of a specific result. A patentee will only be held to an elevated "promise" of utility that is "clear and unambiguous". Where the validity of a patent is challenged on the basis of an allegedly unfulfilled promise, the patent will be construed in favour of the patentee where it can reasonably be read by the skilled person to exclude the elevated/unfulfilled promise.

Apotex asserted that where a patent "lays claim" to a particular use, that use necessarily forms part of the "promise" of the patent. The Court of Appeal rejected this "broad proposition", holding that a result or advantage asserted in a patent's claims "will generally be seen as a promise of utility". Apotex failed to establish how any of the '576 Patent claims contained an explicit promise of treatment in humans. The claim language referred to "subjects", and nothing outside the claims could be said to represent the sort of unequivocal language required. While a promise may appear in the specification if the language to that effect is "clear and explicit", statements made outside of the claims "should not be presumed to be promises".

A single "promise" may not apply to each patent claim

Apotex asserted that the entire patent should be invalidated since a claimed use of the compound in preventing colorectal cancer was neither demonstrated nor soundly predicted as of the patent filing date. The Federal Court of Appeal held that the jurisprudence failed to support Apotex's proposition and that some promises may only apply to a subset of claims. The Court further upheld the application judge's application of section 58 of the Patent Act that invalid claims do not affect valid ones.

No support for abuse of process / stare decisis / judicial comity

The Appellants argued that it was an abuse of process for Pfizer to reject reduced side effects as part of the '576 Patent's "promise", on the basis that Pfizer had previously conceded this point of utility in the Novopharm Case. Apotex argued that a patentee cannot take inconsistent positions in different proceedings dealing with the same patent, relitigate an issue by adducing additional evidence or "elevate the inventive concept to support non-obviousness and then read down the promised utility". Although the Court accepted that "there may be instances where a concession made in one proceeding under the Regulations may be construed as binding upon the conceding party in a later proceeding involving a different party", there is no absolute precedent. As a result, the trial judge did not proceed on an improper principle or a wrongful exercise of discretion. The Court of Appeal also rejected the applicability of stare decisis or comity.  Stare decisis is not unlimited in scope and not every statement in a judgment will be binding on lower courts. In determining the authoritative force of any given passage of a decision, one must essentially ask "What did the case decide?". Whether the '576 Patent's utility included reduced side effects was not decided in the Novopharm Case. Comity or "horizontal stare decisis" is not binding, and there is no legal sanction for a judge's failure to apply comity.

The PLAVIX® appeal to the Supreme Court of Canada is discontinued on consent on the eve of trial

On January 30, 2014, the Supreme Court of Canada (SCC) granted Apotex et al. leave to appeal a decision of the Federal Court of Appeal which overturned a trial decision declaring Canadian Patent No. 1,336,777 claiming clopidogrel bisulphate (commercialized as PLAVIX®) to be invalid.

The hearing was scheduled for November 4, 2014 and six parties were granted leave to intervene, including: Fédération internationale des conseils en propriété intellectuelle, Canada's Research-Based Pharmaceutical Companies, the Centre for Intellectual Property Policy, the International Association for the Protection of Intellectual Property, BIOTECanada and the Canadian Generic Pharmaceutical Association. The SCC was expected to address issues on patent utility including the assessment of the "promise" of the patent and heightened disclosure requirements triggered by the sound prediction analysis.

The appeal to the SCC was discontinued on consent on November 3, 2014.

Eli-Lilly takes further step in NAFTA challenge before arbitration panel

On September 29, 2014, Eli Lilly and Co. filed its Claimant's Memorial (the common name for an advocacy brief in international arbitration proceedings), in the course of its challenge under Chapter 11 of the North American Free Trade Agreement (NAFTA) claiming that Canada's judicial treatment of the "Promise Utility Doctrine" discriminates against pharmaceutical patents and contravenes Canada's international commitments under NAFTA and the Patent Cooperation Treaty (PCT).

In the challenge filed with an arbitration panel on June 13, 2013, US-based pharmaceutical company Eli Lilly and Co. is demanding $500 million in compensation from the Government of Canada for a violation of its obligations to foreign investors under NAFTA, on the basis that it has allowed the Canadian courts to invalidate its patents pertaining to Strattera® (atomoxetine) and Zyprexa® (olanzapine).

Eli Lilly's claim is based on the application of Chapter 11 of NAFTA, which protects the investments of companies and foreign investors having commercial operations in NAFTA's signatory countries. Eli Lilly specifically alleges that the application of the "promise utility" doctrine by Canadian courts is "arbitrary in its application" and "discriminatory in its effects", and is thus in conflict with Canada's commitments under the provisions of Chapter 11, as well as Chapter 17 which requires Canada to provide patents for inventions, in all fields of technology, that are "new, result from an inventive step, and are capable of industrial application".

A Counter-Memorial from the Government of Canada dealing with liability and jurisdiction is due on January 27, 2015. The hearing of this matter is scheduled for May 30, 2016 for a duration of 10 days.

Links to materials:

The Federal Court of Appeal celecoxib decision may be found here.

A copy of Eli Lilly's Claimant's Memorial can be found here.

Other publicly available materials pertaining to the Eli Lilly matter can be found here.


1 Apotex's allegations of insufficient disclosure were rejected on the basis that Apotex failed to properly advance these arguments in its Notice of Allegation.

Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global legal practice. We provide the world's pre-eminent corporations and financial institutions with a full business law service. We have more than 3800 lawyers based in over 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.

Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South Africa (incorporated as Deneys Reitz Inc) and Fulbright & Jaworski LLP, each of which is a separate legal entity, are members ('the Norton Rose Fulbright members') of Norton Rose Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein helps coordinate the activities of the Norton Rose Fulbright members but does not itself provide legal services to clients.

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