Canada: Leaving their mark

This article was originally published in The Patent Lawyer Magazine and is being republished with permission. To read the PDF version of the article  click here.

Over the past year, Canadian Federal Courts left their juristic mark on patent law. This article highlights recent patent decisions addressing the idiosyncratic Canadian concepts of "promise of the patent," "sound prediction," our treatment of methods for medical treatment, and our evolving management of remedies in patent cases. Canadian patent drafting and prosecution tips are also highlighted.

Plavix: The "promise of the patent"

Canada's Federal Courts continue to wrestle with the "promise of the patent" doctrine. The "promise," which invokes the language of guarantee and warranty, refers to the patent's utility. In some cases, the Courts have ventured beyond explicit promises made in the patent to dissect the specification and elevate statements of benefit or advantage to become promises of utility. Where those benefits or advantages were neither demonstrated nor soundly predicted, patents were invalidated for want of utility.

In Sanofi-Aventis v Apotex Inc., 2013 FCA 186, the Court of Appeal addressed the validity of the Plavix® patent through the lens of the patent's "promise." Previously, the trial judge in an impeachment action brought by Apotex found the patent invalid on the bases of inutility and obviousness. The trial judge made his finding notwithstanding an earlier decision of the Supreme Court of Canada in 2008, made in the context of a Patented Medicines (Notice of Compliance) Regulations proceeding, which endorsed the patent's inventiveness.

At trial, the judge held that the patent promised the claimed compound could be used in humans. He then found that although there was a factual basis and sound line of reasoning for such use, the patent claims were invalid for lack of sound prediction of utility on the basis that the patent included insufficient disclosure to support the prediction.

On appeal, the Federal Court of Appeal disagreed with the trial judge's finding of lack of utility. In particular, the Court of Appeal clarified that the "promise of the patent" doctrine does not apply in all cases. Where there is no explicit promise in a patent description, no promise should be "read in" to a patent. In the case of Plavix, there was no explicit promise of use in humans, but rather a mere identification of certain advantages over the prior art. As such, because those advantages were demonstrated by the patentee, the patent was declared to be useful. In addition, the Court of Appeal overturned the trial judge's finding of obviousness.

The Court of Appeal's decision is not the end of the road for the Plavix patent. Recently, Apotex was granted leave to appeal the Court of Appeal's decision to the Supreme Court of Canada. A hearing is scheduled for November 3, 2014.

Eurocopter: Sound prediction and punitive damages

In Bell Helicopter Textron Canada v Eurocopter, 2013 FCA 219, the Court of Appeal addressed the issue of sound prediction in the context of a mechanical invention. In Canada, the requirement for patent utility may be satisfied by evidence of demonstrated utility or a sound prediction of utility. Until Eurocopter, the concept of sound prediction had been applied to pharmaceutical and chemical patents. Indeed, Eurocopter argued that the doctrine of sound prediction could only apply to inventions in those fields since, for example, results in those fields are difficult to predict. In contrast, the utility of mechanical inventions can be demonstrated through mathematical calculations and known rules of physics.

The Court of Appeal disagreed with Eurocopter's arguments, holding that sound prediction may be relevant in mechanical or other non-pharmaceutical inventions. The Court of Appeal found that if there is no evidence of demonstrated utility, and merely "calculations to the effect that the embodiment should work in the manner claimed in the patent, or should give rise to the advantages," then utility must be soundly predicted if it is to be useful.

However, the Court of Appeal made the following comment which arguably softens the harshness of the doctrine in the mechanical fields:

"where the sound prediction is based on knowledge forming part of the common general knowledge and on a line of reasoning which would be apparent to the skilled person (which is often the case in mechanical inventions), the requirements of disclosure may readily be met by simply describing the invention in sufficient detail such that it can be practiced. A contextual approach is thus appropriate in each case."

Novartis: Methods of medical treatment 

In Novartis Pharmaceuticals Canada Inc v Cobalt Pharmaceuticals, 2014 FCA 17, the Federal Court of Appeal grappled, albeit briefly, with Canadian law on methods of medical treatment. Previously, the Federal Court had dismissed Novartis' application for an order prohibiting Cobalt's generic zoledronate, finding Novartis' patent claims to be invalid as they were directed to a method of medical treatment. The patent claims at issue included intermittent administration of "about" once a year for the treatment of osteoporosis.

The Court stated that in order to fall outside the scope of a method of medical treatment, the frequency of administration must not be in the form of a range. Rather, it must be in "vendible product" form and not in the form of a guideline to physicians. The Court indicated that a claim for proper subject matter should be construed as, for example, "the substance X in the form of a 5mg tablet for the treatment of Y." The use of the word "about" was construed by the Court to require the intervention of a physician.

Every claim of Novartis' patent included directions that zoledronic acid was to be used to treat a bone condition. Some claims specified an exact dosage while others specified a dosage range or no specific dosage at all. However, every claim specified that the substance was to be used for intermittent administration. The Court held that the subject matter of these claims lay within the skill of the medical practitioner, and thus the claims were invalid. The Court found that a patent attempting to monopolize a treatment regimen would interfere with the ability of physicians to exercise their judgment, as physicians prescribing the patented drug in the manner disclosed in the patent would be infringing. The Court of Appeal agreed.

Canadian patent laws and regulatory practices possess certain subtleties that should be accounted for when filing patent applications in Canada. Accordingly, companies seeking Canadian patent protection for their innovations need to be aware of unique aspects of Canadian patent law and Canadian Intellectual Property Office (CIPO) practice that can significantly influence the scope and costs of obtaining patent protection in Canada.

Concerning computer implemented acceptable subject matter, it is important to recognize that most, but not all, technology may be considered patentable in Canada if given careful consideration from a Canadian perspective. The Canadian courts have confirmed that business methods are patentable in Canada, which can provide for increased scope of patent protection in computerrelated arts concerning some forms of software and business processes, as long as the patent specification is drafted to reflect the intent of a computer as an essential element of the invention directed to unique business method or software implemented features.

Concerning medical-related acceptable subject matter, claim format and content can make the difference between acceptance or rejection for certain technologies. For example, methods that provide practical therapeutic benefits to subjects may be considered "methods of medical treatment" that are not patentable in Canada. However suitable claims may be drafted to instead claim an allowable "use." Also, higher life forms – such as mice or other mammals, and plants – are not patentable in Canada, however a higher life form can still be patented by directing the claims to a cell comprising a patentable nucleic acid.

Refining remedies in patent cases

Apotex v Takeda and Abbott, 2013 ONCA 555 – (no to innovator profits): In this case, the Ontario Court of Appeal upheld the summary judgment dismissal of Apotex's claim for disgorgement of Takeda's and Abbott's profits in the context of a Section 8 PM(NOC) proceeding. Section 8 provides a generic drug manufacturer with the ability to claim compensation for losses suffered as a result of a delayed market entry caused by a patentee's application to prohibit such generic's market entry. A key finding of the Court of Appeal was that, according to section 8, the recoverable loss may be no more than the generic's damages and does not extend to an innovator's profits. In addition, the Court of Appeal rejected Apotex's allegation of unjust enrichment on the basis that the PM (NOC) Regulations provide a valid juristic reason for an innovator's exclusive presence in the market.

Bell Helicopter v Eurocopter, 2013 FCA 219 – (yes to punitive damages in Non-PM (NOC) patent cases): In addition to the Court's findings on sound prediction, Eurocopter is also notable for its ruling on punitive damages. Previously in Canada, punitive damages were not available for so-called wilful infringement. However, the Court of Appeal in Eurocopter upheld the order for punitive damages on the basis of Bell Helicopter's "slavish" copying of Eurocopter's patented product, and the fact that Bell Helicopter, as a "sophisticated" company, ought to have known of Eurocopter's patent. The Court of Appeal cautioned that punitive damages are only available in patent cases where "the evidence shows that there has been high-handed, malicious, arbitrary or highly reprehensible conduct that departs to a marked degree from the ordinary standards of decent behaviour." Nevertheless, the only remarkable behaviour in this case was the defendant's copying with imputed knowledge of the patent.

Teva v Pfizer, 2014 FCA 138 – (no to punitive damages in PM (NOC) cases): On May 27, 2014, the Federal Court of Appeal upheld the striking of Teva's claim for punitive and exemplary damages in its action for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations. Teva claimed such damages following Pfizer's failed prohibition proceedings involving the drug sildenafil, marketed by Pfizer as VIAGRA®. The Court noted that punitive damages may be awarded in patent actions generally (see Eurocopter, above) but held that the PM (NOC) Regulations specifically preclude claims for punitive and exemplary damages because the regulatory scheme is limited to providing compensatory relief. The Court noted that, by their very nature, punitive damages are not compensatory. The Court also held that section 8(5), which permits the Court to "take into account all matters" in assessing the "amount of compensation," cannot sustain a claim for punitive damages.

Apotex v Sanofi-Aventis, 2014 FCA 68/ Teva v Sanofi-Aventis, 2014 FCA 67 – (yes to regulations in the "hypothetical world"): In concurrent cases involving ramipril, the Federal Court of Appeal further defined the scope of section 8 of the PM(NOC) Regulations. Section 8 damages are calculated by considering the generic manufacturer's loss in a hypothetical world where it starts selling without the delay occasioned by the Regulations. The Court of Appeal addressed the unique facts presented and made the following more notable findings:

  • Both generic claimants and generic competitors are subject to the Regulations in the hypothetical world, except for the sole purpose of determining the start date of the period of liability.
  • As they are subject to the Regulations, generic claimants in the hypothetical world will send Notices of Allegation to address patents listed against the drugs they seek to copy thus largely erasing the notion that innovators will be "taken by surprise" by a generic launch.
  • Generic claimants will be subject to a reduction in revenues for "ramp-up" in the hypothetical world.

AbbVie v Janssen, 2014 FC 489 – (yes to modified permanent injunctions): In its decision of May 22, 2014, the Court addressed whether AbbVie was entitled to an injunction notwithstanding the fact its own product did not fall within the scope of the patent claims at issue. In Canada, a permanent injunction will normally follow once the Court finds that a patent is valid and infringed. In the unique circumstances of this case, the Court balanced AbbVie's rights to exclusive use of its claimed invention with the public need to have continued access to the infringing drug which could only be obtained from Janssen. The Court granted a limited form of injunction, which permits physicians to continue prescribing Janssen's infringing product to patients already receiving that drug and to new patients, provided that their own physicians have determined it's necessary for treatment. Janssen was required to pay a royalty to AbbVie for any continuing sales.

Sufficiency of disclosure of the Canadian patent application is an important consideration, as support for the required claim form or content must be found in the patent application description as filed. Therefore, consideration should be given to the way in which the subject matter of the Canadian patent application is described in order to best capitalize on Canadian patent protection for the invention. Important ramifications on actual content of the disclosure are related to promise of the patent and sound prediction principles recently decided upon by Canadian courts. Further consideration and care should be taken to have sufficient support in the disclosure to support claiming of feasible alternative embodiments.

Examination of a Canadian patent application is not automatic upon filing and must be requested by the applicant within up to five years from the Canadian application filing date. During this time, the applicant can take advantage of deferred examination to properly assess the best manner in which the Canadian patent claims should be pursued. For example, examination results obtained from corresponding patent applications in other countries can be influential once starting the Canadian examination process, which can be used to make sure that proper claim content is present in the patent.

Proper claim content in a Canadian patent should be considered as Canada does not use terminal disclaimers between applications owned by the same party. This can influence filing divisional applications in Canada, where it is advisable to include or add all desired claims in a pending patent application to allow the Canadian examiner to determine whether separate inventions are claimed, which can help avoid a later allegation in the courts of "double patenting". The divisional practice in Canada is something that should be considered by applicants when a number of alternative embodiments are desirable.

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.

Events from this Firm
16 Jan 2018, Seminar, Birmingham, UK

Join Gowling WLG's pensions team as they explain some of the biggest challenges facing trustees and employers in the coming year and provide practical ways of dealing with them.

23 Jan 2018, Seminar, London, UK

Join Gowling WLG's pensions team as they explain some of the biggest challenges facing trustees and employers in the coming year and provide practical ways of dealing with them.

25 Jan 2018, Seminar, Birmingham, UK

2018 is set to be another big year in employment, with employers set to face new challenges and responsibilities. At our event, looking ahead to next year, we will be discussing four key issues you might face in 2018, providing useful tips and answering your questions.

In association with
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
Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:
  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.
  • Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.
    If you do not want us to provide your name and email address you may opt out by clicking here
    If you do not wish to receive any future announcements of products and services offered by Mondaq you may opt out by clicking here

    Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

    Use of

    You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


    Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

    The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


    Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

    • To allow you to personalize the Mondaq websites you are visiting.
    • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
    • To produce demographic feedback for our information providers who provide information free for your use.

    Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

    Information Collection and Use

    We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

    We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

    Mondaq News Alerts

    In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


    A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

    Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

    Log Files

    We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


    This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

    Surveys & Contests

    From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


    If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


    This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

    Correcting/Updating Personal Information

    If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

    Notification of Changes

    If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

    How to contact Mondaq

    You can contact us with comments or queries at

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions