Canada: Ontario Court Of Appeal Allows Sanofi And Schering To Plead That Federal Court Ramipril Patent Invalidity Decision Was Flawed Due To "Promise Doctrine"

In an action by Apotex for compensation from Sanofi and Schering under the Ontario Statute of Monopolies, U.K. Statute of Monopolies and the Trade-marks Act, the Ontario Court of Appeal has overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc. v Apotex Inc., 2017 SCC 36 [AstraZeneca]: Apotex Inc. v Schering Corporation, 2018 ONCA 890.


The litigation relates to Canadian Patent No. 1,341,206 ("206 patent"), owned by Schering, and the drug ramipril (ALTACE), previously marketed by Sanofi.

In 2009, applying the "promise doctrine" of patent utility, the Federal Court held that certain claims of the 206 patent were invalid (Sanofi-Aventis Canada v Apotex Inc., 2009 FC 676 ("invalidity decision") aff'd 2011 FCA 300). Relying on that invalidity decision, Apotex brought the present action in 2011 seeking damages beyond those available under section 8 of the PMNOC Regulations. The Federal Court has already awarded damages under section 8 (Apotex Inc. v Sanofi-Aventis, 2012 FC 553, var'd 2014 FCA 68, aff'd 2015 SCC 20).

The Supreme Court of Canada subsequently rejected the promise doctrine, finding in AstraZeneca that it was "unsound" law and not the correct approach for assessing patent utility (previously reported).

Decision under appeal

In light of AstraZeneca, Sanofi and Schering sought leave to amend their statements of defence to plead that the Federal Court relied on wrong legal principles in finding the 206 patent claims invalid. Leave was denied by Dunphy J. (reported here), primarily on the grounds that the defences amounted to re-litigation and collateral attack of the invalidity decision. On November 8, 2018, the Ontario Court of Appeal overturned the motion judge's decision and allowed Sanofi's and Schering's amendments.

"Special circumstances" exception to issue estoppel and collateral attack

The Court of Appeal determined that issue estoppel should not prevent the amendments. Contrary to the motion judge's reasons, the Court of Appeal held that statutory amendments are not the only changes in the law relevant to the special circumstances exception to issue estoppel; the exception also contemplates a decision by a court on a point of law. AstraZeneca was such a decision – by the Supreme Court of Canada – on a point of law "central" to the invalidity decision.

The Court of Appeal repeated earlier guidance by the Supreme Court of Canada that the "most important factor" in determining whether issue estoppel should apply is whether "taking into account the entirety of the circumstances, ... application of issue estoppel in the particular case would work an injustice" (Danyluk v Ainsworth Technologies Inc., 2001 SCC 44). The Court stated "...the strict application of issue estoppel in this case would work an injustice on [Sanofi and Schering]..." The Court noted the invalidity decision is "central" to Apotex's claim and it would be "fundamentally unfair" to deprive Sanofi and Schering of the opportunity to argue that the invalidity decision is suspect.

The Court of Appeal rejected the view that the potential for delay or expansion of the trial in the action (if re-litigation of validity is required) should bar the amendments. The Court of Appeal noted that Apotex is the party who is effectively raising the issue by pursuing its "novel claim" for an "extraordinary level of damages" beyond what it has already received in the Federal Court. In that context, Apotex cannot complain if Sanofi and Schering are given an "equal opportunity to defend."

Moreover, the Court of Appeal found that applying the special circumstances exception in the present case would not undermine the objective of finality underlying res judicata and related doctrines, contrary to the motion judge's reasons and a recent decision of the Federal Court of Appeal (Eli Lilly Canada Inc. v Teva Canada Ltd., 2018 FCA 53, leave to appeal refused, SCC Case No. 38077). The Court of Appeal noted that each case requires its own contextual consideration of the discretion not to apply issue estoppel. AstraZeneca represented a rare foundational change in the law, by the Supreme Court of Canada, on a fundamental legal point. As such, the present case is "precisely the type of special circumstance where the principle of finality should yield to the justice of the case."

The Court of Appeal also refused to apply the doctrine of collateral attack to preclude Sanofi's and Schering's amendments, concluding that to do so would "work the same injustice" as issue estoppel.

Federal Court's obviousness finding does not bar the amendments

As the Federal Court of Appeal had expressly declined to comment on the alternative finding of obviousness in the invalidity decision, labelling it "obiter", the Ontario Court of Appeal concluded that in these circumstances the invalidity decision "cannot be considered to be binding on the basis of obviousness" and it would be unfair to hold Sanofi and Schering to it.

Apotex has several Statute of Monopolies claims pending

The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and U.K. Statute of Monopolies. One such action is scheduled for trial in May of 2019.

Sanofi was successfully represented by Gunars Gaikis, Lynn Ing and Brandon Heard of Smart & Biggar.

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.

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
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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