Canada: Apotex Fails To Establish It Would Have Obtained Non-Infringing Perindopril From Foreign Third-Party Suppliers; Original $61+ Million Profits Award Stands

Last Updated: April 30 2018
Article by Urszula Wojtyra

Servier and its related company ADIR were successful in another chapter of patent litigation relating to perindopril (Servier's COVERSYL): the Federal Court again dismissed Apotex's non-infringing alternative defence, finding that Apotex would not have called on foreign third parties to manufacture perindopril to supply Apotex affiliates in the UK and Australia. The Court thereby re-affirmed its original judgment that Apotex Inc. and Apotex Pharmachem Inc. (collectively Apotex) must pay all their profits attributable to infringement of ADIR's patent: ADIR v Apotex Inc, 2018 FC 346.

Background: Starting in 2006, Apotex manufactured perindopril tablets in Canada, and sold these in Canada and to its UK and Australian affiliates. As previously reported, in 2008, the Federal Court found these activities infringed ADIR's Canadian Patent No. 1,341,196 ("196 patent"): 2008 FC 825, aff'd 2009 FCA 222 and enjoined Apotex from infringing the patent. The plaintiffs elected an accounting of Apotex's profits as their remedy.

Initial reference decision and appeal: While Apotex did not dispute it was required to disgorge profits from its domestic sales, Apotex argued that its profits from sales to its UK and Australian affiliates were not attributable to infringement of the 196 patent. Apotex asserted it could have avoided infringement, and made the same or higher profits, by enlisting third-parties in foreign countries to manufacture the perindopril.

In 2015, the Federal Court dismissed the legal relevance of Apotex's alleged non-infringing alternative defence, but the Federal Court of Appeal held that was an error (as reported previously, ADIR v Apotex Inc, 2015 FC 721, overturned 2017 FCA 23). The Federal Court of Appeal thereby remitted back to the Federal Court the factual issue of whether, in a hypothetical world where Apotex did not infringe, Apotex could and would have obtained non-infringing perindopril from three specific third-party suppliers, and, if so, whether Apotex could and would have sold this material to its UK and Australian affiliates.

The "could have" analysis: In order to succeed on this branch of the test, Apotex had to establish that it could have transferred the required technology to the third-party suppliers, obtained the required marketing approvals, and manufactured the required quantities of the perindopril active pharmaceutical ingredient and tablets, all in the relevant timeframe. On the basis that it was the 'fastest means' for Apotex to obtain non-infringing perindopril, the Court proceeded on the theory that the third-party suppliers would have been included in Apotex's original regulatory applications.  

The Court found that each of the three third-party suppliers could have supplied the necessary perindopril but rejected Apotex's proposed timeline for replacement of all real world sales as 'utopic', requiring all events in the hypothetical world to occur perfectly, which the Court found unrealistic. Instead, using the 'broad axe' principle, the Court concluded Apotex could have started selling non-infringing perindopril one year after it had started selling in the real world.

The "would have" analysis: The Court concluded that this branch of the test is largely subjective, and that the "intentions, motivations and preferences of an infringing party must be considered." Therefore, inferences must be drawn from objective evidence led at trial and from what transpired in the real world in order to make a conclusion on this branch.

The Court held that Apotex did not establish it would have used a third-party supplier to produce non-infringing perindopril, relying on real world facts, including that:

  • Apotex chose to manufacture perindopril in Canada even though the evidence established it could have made more profits outsourcing to third-party suppliers,
  • Apotex had a preference for doing everything in Canada,
  • Apotex preferred to manufacture products at its own sites rather than contracting to non-affiliated third parties, and
  • Apotex only enlisted its foreign affiliates to manufacture perindopril product and ultimately sold that non-infringing product to its UK and Australian affiliates after it was enjoined from manufacturing in Canada.

The Court held that in the hypothetical world, Apotex would have done exactly what it did in the real world, pursued its technology transfers to its own foreign affiliates rather than third-party suppliers, and would have entered the foreign markets at a later date than it did in the real world.

The Court therefore re-affirmed the quantum of profits from its original judgment, holding that Apotex and Apotex Pharmachem must collectively pay over $61 million.

Apotex may appeal as of right.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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.

Urszula Wojtyra
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