Canada: Ontario Superior Court Refuses To Strike Generic's Damages Claim Against Pharmaceutical Innovator Based On 400-Year-Old Statute

Last Updated: September 14 2015
Article by Kiernan A. Murphy

On August 27, 2015, the Ontario Superior Court of Justice declined to strike1 a claim by Apotex against Eli Lilly and Company and Eli Lilly Canada Inc for treble damages and double costs pursuant to the almost 400-year-old Statute of Monopolies and its 118-year-old Ontario descendant (collectively, the "Monopolies Acts"). Apotex claimed these damages, along with damages under the Patented Medicines (Notice of Compliance) Regulations, following a prohibition proceeding involving the drug atomoxetine. There, Lilly had established that Apotex's allegations of invalidity were unjustified, but the Court nonetheless dismissed the proceeding on the basis that it was moot because it found the asserted patent invalid in a parallel impeachment action involving another generic manufacturer. Apotex then began this action for damages against Lilly in the Ontario Superior Court of Justice.

The Court held that it was premature to confine the Monopolies Acts to the history books before Parliament or a Court has had an opportunity to consider them in detail upon a proper factual background. The Court held that it was not plain and obvious that no claim could be advanced under either or both of those statutes.  

Not plain and obvious that the Patent Act and NOC Regulations are a complete code

The high threshold for striking a claim was not in dispute: it must be plain and obvious, assuming the facts pleaded to be true, that the pleading discloses no reasonable cause of action or that the claim has no reasonable prospect of success.

The Court was not satisfied that the Patent Act and the NOC Regulations constitute a "complete code" which preclude all other claims. For example, the Court found that the Patent Act itself does not address the consequences of an invalid patent as regards a frustrated competitor or consumer. The Court held that the jurisprudence addressing the "complete code" argument in respect of common law causes of action was inconclusive and thus, in the absence of a binding Court of Appeal decision accepting it, the law was not settled.

The Court disagreed that section 8 of the NOC Regulations is part of a complete and comprehensive scheme which provides both the duty and adjudicative machinery to deal with that scheme. The Court added that the outcome of the prohibition proceeding is irrelevant to the Monopolies Acts claims. Section 8 damages claims and Monopolies Acts claims were thus at least arguably distinct claims. The Court noted that neither the Patent Act nor its subordinate NOC Regulations explicitly purported to foreclose claims under the Monopolies Acts.

Not plain and obvious that the Monopolies Acts do not apply

The Court held that it was at least arguable that the 1624 Statute of Monopolies was among the body of law incorporated into Upper Canada in 1792 and thus survived through to the constitution in 1867. It was thus not plain and obvious that it is not in force in Ontario and other parts of Canada. The Court added that there was no question of validity raised about its more recent Ontario descendant, which is materially identical to the 1624 Statute of Monopolies.

The Court then found the Monopolies Acts to arguably apply to patents, at least in the manner alleged by Apotex. Having been found to be invalid and thus void ab initio, arguably the rights used to grieve Apotex were without lawful foundation and thus cannot be sheltered from the Monopolies Acts. The Court described Apotex's theory of the case to be that an unlawful monopoly was used to optionally and voluntarily list the invalid patent on the Patent Register where the foreseeable and intended effect was to cause Apotex to be grieved in obtaining its NOC and selling its product. The Court held that the purpose of the damages contemplated by the Monopolies Acts was to dissuade such use of unlawful monopolies.

The Court also did not find it plain and obvious that exemptions for "new manufactures" and "true and first inventor" applied as the patent in question was never a valid patent nor was it in respect of a "new manufacture" or "true first inventor". The Court applied similar logic to the argument that the Statute of Monopolies ought to be read down to avoid infringing on federal patent jurisdiction, holding that the claim arose from the invalidity of a patent, not the validity of one.


The Court permitted Apotex to take its Monopolies Acts claim to trial because it was not plain and obvious that Apotex's claim was bound to fail. The threshold has always been very low for allowing novel claims such as this one to proceed to trial. However, the Courts have yet to hold that a claim such as Apotex's Monopolies Acts claim is in fact viable. A trial judge, apprised of the complete factual circumstances and with a more fulsome review of the law, may well ultimately find claims such as Apotex's claim unfounded in law or untenable on the facts. Nonetheless, without further guidance from the Court, it is difficult to foresee what kinds of activities could potentially trigger claims under the Monopolies Acts, should such claims find traction in the Courts.


1 Apotex Inc v Eli Lilly and Company et al, 2015 ONSC 5396

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
8 Nov 2016, Seminar, Ottawa, Canada

The prospect of an internal investigation raises many thorny issues. This presentation will canvass some of the potential triggering events, and discuss how to structure an investigation, retain forensic assistance and manage the inevitable ethical issues that will arise.

22 Nov 2016, Seminar, Ottawa, Canada

From the boardroom to the shop floor, effective organizations recognize the value of having a diverse workplace. This presentation will explore effective strategies to promote diversity, defeat bias and encourage a broader community outlook.

7 Dec 2016, Seminar, Ottawa, Canada

Staying local but going global presents its challenges. Gowling WLG lawyers offer an international roundtable on doing business in the U.K., France, Germany, China and Russia. This three-hour session will videoconference in lawyers from around the world to discuss business and intellectual property hurdles.

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
Check to state you have read and
agree to our Terms and Conditions

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.

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 by clicking here .

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.


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.