Canada: Pharma In Brief - Canada: Federal Court Releases Decisions In Ramipril Section 8 Cases

Case: Apotex Inc. v. Sanofi-Aventis (T-1357-09); Sanofi-Aventis v. Teva Canada Limited (T-1161-07)

Drug: ALTACE® (ramipril)

Nature of case: Section 8 of the PM(NOC) Regulations – validity and quantification of damages

Date of decision: May 23, 2012


On May 23, 2012, the Federal Court released its public reasons in three companion decisions, all written by Madam Justice Snider, in respect of litigation brought separately by Teva Canada Limited ("Teva") and Apotex Inc. ("Apotex") against Sanofi-Aventis and related companies ("Sanofi") pursuant to section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"). The claims concerned damages sustained by Teva and Apotex while they were prevented from marketing their generic ramipril products as a result of ultimately unsuccessful prohibition proceedings initiated by Sanofi.

The first decision, 2012 FC 551, concerned the validity of section 8 of the Regulations. The second two decisions, 2012 FC 552 (the "Teva Action") and 2012 FC 553 (the "Apotex Action") considered the quantification of Teva's and Apotex's damages. These are the first cases to proceed to a decision on issues of quantification under section 8.

Validity of section 8

The Court held that section 8 of the Regulations is enabled by the Patent Act and rejected each of Sanofi's invalidity arguments. The Court noted that the Alendronate1 decision, in which the Federal Court of Appeal considered the validity of section 8 of the Regulations on constitutional and jurisdictional grounds, provided strong direction to the Court in this case.

The Court held that many of Sanofi's arguments relating to the breadth of s. 8 did not arise. On this basis, the Court dismissed Sanofi's arguments that section 8 is overbroad because: (i) it imposes liability prior to the commencement of a prohibition proceeding; (ii) it imposes liability for a period after the issuance of an NOC; (iii) it does not allow a court to consider generic competition and imposes liability for sales made for unapproved indications; and (iv) it permits recovery where the marketing of the generic version would constitute patent infringement. With respect to the infringement argument, the Court also pointed out that this issue was decided by the Federal Court of Appeal in Alendronate. The Court also held that section 8 is not contrary to Canada's obligations under NAFTA or TRIPS.

The quantification decisions

The Teva and Apotex Actions both involved complex background facts and procedural histories. These complex backgrounds gave rise to highly fact specific determinations. Nonetheless, these decisions will provide useful guidance in future section 8 cases.

Some of the major issues that were in dispute are summarised briefly below.

Relevant time frame

In both cases, the parties disagreed on when the period of liability should begin and end. The Court noted that the language of section 8 provides discretion with respect to the commencement date, but not with respect to the end date.

Teva Action

The Court held that the liability period cannot begin before the statutory stay is imposed by the Regulations even where the generic product has been certified as "approvable" by Health Canada. In so doing, the Court rejected Teva's argument that section 8 calls for a determination of what would have happened in the complete absence of the Regulations. The purpose of section 8 is to compensate for losses as a result of the statutory stay.

Based on this holding, the Court considered it highly relevant that Teva indicated in its regulatory submission that it would wait until the expiry of one of the patents listed in respect of ramipril to obtain its NOC. Given this "business decision" the Court held that the appropriate commencement date for the purposes of section 8 liability was the date of expiry of the patent.

Apotex Action

The parties disagreed on both the start and end dates of the liability period.

The Court held that the period of liability began on the date Apotex's ramipril product was approvable. The Court rejected Sanoi's argument that the liability period should commence later than the approvability date on the basis that while it had been unsuccessful in obtaining a prohibition order based on a later Notice of Allegation filed by Apotex, it had obtained a prohibition order based on an earlier Notice of Allegation. The Court held that the dismissal of a later prohibition proceeding in respect of the same patent essentially "trumped" the existing prohibition order and the Minister would not have been prevented from issuing the NOC following the dismissal of the later proceeding.

The Court held that the period of liability in this case ended on the day on which Apotex received its NOC for its ramipril product. In so doing, the Court rejected Apotex's argument that the delay period should run until the last prohibition proceeding was formally dismissed, which in the unique circumstances of this case took place after the date on which Apotex obtained its NOC. Based on the compensatory nature of section 8, the Court held that the outstanding prohibition proceeding, which had been rendered moot by the Minister's prior decision that Apotex was not required to address certain patents, was "effectively dismissed" on the date Apotex received its NOC. Therefore, Apotex could not collect damages for the period in which it had its NOC notwithstanding the fact that the final prohibition proceeding had not been formally dismissed.

Relevant Market

In determining what each generic manufacturer's market would have been, the Court held that it was entitled to consider generic competition, including the effect of any so called authorized generics. That said, the Court rejected Sanofi's argument that the Court should necessarily construct a single "but for" world applicable to all the ramipril section 8 proceedings. Instead, the Court held that each case should be determined on its own facts and evidence.
In respect of the burden of establishing the competitive generic market, the Court held that while Teva and Apotex had the ultimate legal burden of proving their losses, that did not mean that they needed to call every other generic manufacture to establish that they would not have entered the ramipril market. Rather, once Teva and Apotex proved their losses, Sanofi had an evidentiary burden with respect to the presence of other generics in the market.

In both actions, the Court held that Apotex and Teva, respectively, had the regulatory ability, capacity, and motivation to enter the ramipril market during the liability period. Sanofi also established that it would have introduced an authorized generic into the market following generic entry. Expert evidence was relied on in order to assess the relative market shares. In the Apotex Action, the court determined that Apotex would have held 100% of the generic market for a period, 70% of the generic market following the entrance of an authorized generic, and 50% of the market following the entrance of Teva.

In the Teva Action, the Court held that all three of Teva, Apotex and an authorized generic would have entered the market at the same time, and would have split the generic market evenly.

Trade-spend (rebates)

The issue of the appropriate rebate levels were raised in both cases. Unfortunately, the final values arrived at by the Court, and the values suggested by each party were redacted. It is therefore difficult to determine precisely how the Court arrived at its determination with respect to rebates. However, the Court clearly stated that rebates and other trade allowances or discounts should be deducted from revenue when calculating net profits.

The "double ramp up" and other future losses

In both actions, Apotex and Teva argued that since they suffered a ramp-up period in the actual world, they should not also be required to suffer a ramp-up period in the "but for" world.

The Court held that the generic manufacturers' attempt to avoid a second ramp-up was in effect a claim for losses suffered outside of the relevant period and was not compensable under section 8. Similarly, while Teva attempted to frame its "lost business value" as occurring within the relevant period by using a valuation date within the period, the Court agreed with the characterisation that these were nonetheless losses suffered outside of the period and therefore were not recoverable.


The Court referred the matter back to the parties in order to determine the final actual amount owed by Sanofi to each of Teva and Apotex in accordance with its findings.

Links to decisions:

Sanofi-Aventis v. Teva Canada Limited, 2012 FC 551 (Validity)

Sanofi-Aventis v. Teva Canada Limited, 2012 FC 552 (Teva Action)

Apotex Inc. v. Sanofi-Aventis, 2012 FC 553 (Apotex Action)


1 Apotex Inc. v. Merck & Co, 2009 FCA 187; rev'g 2008 FC 1185, leave to appeal to SCC refused [2009] SCCA No 347.

Norton Rose Group

Norton Rose Group is a leading international legal practice. We offer a full business law service to many of the world's pre-eminent financial institutions and corporations from offices in Europe, Asia, Australia, Canada, Africa, the Middle East, Latin America and Central Asia.

Knowing how our clients' businesses work and understanding what drives their industries is fundamental to us. Our lawyers share industry knowledge and sector expertise across borders, enabling us to support our clients anywhere in the world. We are strong in financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and pharmaceuticals and life sciences.

We have more than 2900 lawyers operating from 43 offices in Abu Dhabi, Almaty, Amsterdam, Athens, Bahrain, Bangkok, Beijing, Bogotá, Brisbane, Brussels, Calgary, Canberra, Cape Town, Caracas, Casablanca, Dubai, Durban, Frankfurt, Hamburg, Hong Kong, Johannesburg, London, Melbourne, Milan, Montréal, Moscow, Munich, Ottawa, Paris, Perth, Piraeus, Prague, Québec, Rome, Shanghai, Singapore, Sydney, Tokyo, Toronto and Warsaw; and from associate offices in Dar es Salaam, Ho Chi Minh City and Jakarta.

Norton Rose Group comprises Norton Rose LLP, Norton Rose Australia, Norton Rose Canada LLP, Norton Rose South Africa (incorporated as Deneys Reitz Inc), and their respective affiliates.

On January 1, 2012, Macleod Dixon joined Norton Rose Group adding strength and depth in Canada, Latin America and around the world. For more information please visit

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.

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.