Canada: Federal Court Finds PLAVIX Patent Invalid

Last Updated: January 17 2012
Article by Urszula Wojtyra

On December 6, 2011, Justice Boivin of the Federal Court held that Apotex infringed the patent that claims clopidrogel bisulfate (sanofi-aventis's PLAVIX) but that the patent was invalid: Apotex Inc. v. sanofi-aventis 2011 FC 1486, appeal pending.

The same patent ('777) had previously been the subject of litigation under the Patented Medicines (Notice of Compliance) Regulations. As reported in the November 2008 special edition of Rx IP Update, the Supreme Court of Canada upheld the Order of prohibition preventing the Minister of Health from issuing a Notice of Compliance ("NOC") to Apotex (2008 SCC 61). Following its loss in the Supreme Court, Apotex brought an impeachment action, and sanofi-aventis followed with an infringement action. The December 6 decision relates to both actions.

The '777 patent discloses and claims the enantiomer clopidogrel and its bisulfate salt, as well as processes for its manufacture. An earlier patent ('875) encompassed clopidogrel bisulfate within its claims and included an example describing the racemate. The claims also referred to enantiomers.

Starting with the position that the '777 patent is a selection patent, the Federal Court concluded that the invention of the '777 patent is a compound that is useful in inhibiting platelet aggregation, has greater therapeutic effect and less toxicity than the other compounds of the '875 genus patent, including the racemate and the opposite enantiomer, has the advantages of the salts (crystallize easily, not hygroscopic and sufficiently water-soluble) and the methods for obtaining that compound. Further, the Federal Court held that the patent made an explicit promise for the use of the compound in humans.

Invalidity. The Federal Court rejected Apotex's assertions that the '777 patent was invalid for overbreadth, insufficiency, lack of novelty and double-patenting. The Federal Court's decision is consistent with the Supreme Court's ruling on the latter two grounds.

The Federal Court found the patent invalid on the basis of lack of utility, both demonstrated or soundly predicted, and obviousness.

Demonstrated utility. Sanofi-aventis had argued that the promised utility had been demonstrated as of the Canadian filing date, at which time a phase 1 clinical study of the compound was underway. While some of the results of the double-blind study were known to sanofi-aventis at the date of filing, the study was not completed until one month later. The Federal Court held that the early results known by sanofi-aventis were inconclusive on the issue of the promised utility.

Sound prediction. With regards to sound prediction, the Federal Court found that sanofi-aventis had a "track record" studying compounds with similar structures to clopidogrel bisulfate. As a result of this "track record," sanofi-aventis established that it had a factual basis and sound line of reasoning for predicting that clopidogrel bisulfate could be used in humans. However, the Court found that the patent did not disclose this "track record," which the Court held was needed to assist the skilled person to predict the promised use. As a result, the patent failed the disclosure branch of the sound prediction test.

Obviousness. In contrast to the Supreme Court's finding that Apotex's allegation of obviousness was not justified in that proceeding, the Federal Court held the invention of the '777 patent "obvious to try." The Federal Court reasoned that the racemate of clopidogrel was part of the common general knowledge of the skilled person, that the skilled person would have been motivated to resolve the enantiomers of a racemate, and that a particular method of resolving the enantiomers would have been routine at the time.

Infringement. While in principle moot because of the finding of invalidity, the Federal Court nonetheless addressed sanofi-aventis's claim of infringement. The Federal Court held that Apotex infringed the '777 patent by, among other acts, importing clopidogrel bisulfate and exporting Apo-clopidogrel tablets to the United States.

In the U.S., the parties had entered into settlement agreements regarding the U.S. litigation relating to the U.S. patent claiming clopidogrel bisulfate. By the agreements, Apotex's liability for infringement in the U.S. was limited to 50% of its net sales. Apotex had argued that sanofi-aventis was precluded from recovering for the U.S. Apo-clopidogrel on the basis of these settlement agreements. The Federal Court disagreed, finding the agreements did not consider the '777 patent and were limited to the U.S. patent and U.S. litigation.

Sanofi-aventis's motion for an interim stay was dismissed. A number of generic manufacturers have since received NOCs for their clopidogrel bisulfate products.

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.

Urszula Wojtyra
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.