Canada: Allegations Against Canadian Tenofovir Patent Found Unjustified (Again)

Gilead's Canadian Patent 2,261,619 (the "619 Patent")—the compound patent for tenofovir disoproxil fumarate ("TDF")—is no stranger to Canadian courts. Adding to its litigious history, the Federal Court recently dismissed each of Apotex's claims in an application under Canada's NOC Regulations to find—for a second time—allegations relating to the 619 Patent's validity unjustified.


The multitude of Canadian proceedings pertaining to the 619 Patent stems in part from the fact that TDF is the active ingredient in a number of anti-HIV medications: Gilead markets two different drugs containing TDF (TRUVADA® and VIREAD®), while Bristol Myers Squibb (BMS) markets ATRIPLA® which also contains TDF.

In late 2011, Teva served Gilead with a separate Notice of Allegation (NOA) with respect to each of TRUVADA® and VIREAD®, and another NOA on BMS in respect to ATRIPLA®. In response, Gilead and BMS commenced three separation applications (Court Files T-8-12, T-280-12 and T-1708-12) under Canada's NOC Regulations seeking orders prohibiting the Minister from issuing NOCs to Teva until the expiry of two patents, including the 619 Patent. Ultimately, the Court dismissed Teva's allegations of invalidity concerning the 619 Patent and granted an order prohibiting the Minister from issuing NOCs to Teva until expiry of the 619 Patent on July 25, 2017.1

While the prohibition proceedings were still pending, in August 2012, Teva commenced an impeachment action against Gilead, seeking, inter alia, a declaration that the 619 Patent was invalid, void and of no force and effect (Court File T-1529-12). Notwithstanding its unsuccessful result in the prohibition proceeding, Teva continues to prosecute its impeachment action, which is set to be heard in November 2016.

The Apotex Case

Despite allegations of invalidity already having been dismissed by the Court relating to the 619 Patent, an ongoing impeachment action with another generic manufacturer, and the 619 Patent's expiry in July 2017, Apotex too sent NOAs to Gilead in respect of both TRUVADA® and VIREAD®.

While TDF is the sole active ingredient in VIREAD®, TRUVADA® is a combination drug comprised of VIREAD® (TDF) and another drug: emtricitabine or FTC. In response, Gilead commenced two applications pursuant to Canada's PM(NOC) Regulations relating to VIREAD® (Court File No. T-1694-14) and TRUVADA® (Court File T-1693-14). In the TRUVADA® case, the Court had determined earlier that the 619 Patent was ineligible for listing on the Patent Register and therefore ineligible for inclusion in that proceeding2 (see our earlier report on the decision here).

In the VIREAD® case reported here, at issue was a single claim (claim 32) that disclosed the compound tenofovir disoproxil ("TD") and its salts, tautomers and solvates. While Apotex admitted infringement it alleged a number of grounds of invalidity including anticipation, obviousness, invalid selection and inutility. Ultimately the Court dismissed each of Apotex's allegations and granted an order prohibiting Apotex from receiving a NOC for VIREAD® until expiry of the 619 Patent.


As Teva had argued earlier (unsuccessfully), Apotex alleged that the 619 Patent was anticipated in light of European Patent Application 214. Central to Apotex' argument was whether a particular carbonate on TDF was disclosed as a possible substitution in the genus described in EP214. The Court concluded EP214 did not satisfy the disclosure requirement as the particular carbonate was not explicitly referred to and thus, the application did not provide so clear a direction that a skilled person reading and following it would in every case and without possibility of error be led to the claimed invention.

Selection Patent

Apotex argued that the 619 Patent was an invalid selection from the genus disclosed in EP214. As it had determined in respect of Apotex's anticipation allegation, the Court concluded on the evidence that EP214 did not include within its genus a class encompassing TD. Nevertheless, the Court was satisfied that even if EP214 included TD, the 619 Patent still presented a particular and special advantage over other members of the claimed genus not disclosed in EP214.


In addressing Apotex's allegation of obviousness, ultimately the Court was unsatisfied that the skilled person would have been directly led to the solution given the experiments demonstrating chemical instability of carbonate moieties for parent drugs similar to tenofovir and given the unpredictable results when combining moieties—it was simply not obvious that a carbonate subgroup ought to work.

Of particular note was the Court's comments with respect of one of Apotex's witness who filed an affidavit "in which he admitted contained two significant false statements", which related to the reference in the prior art to the application of the prodrug strategy to tenofovir. In this respect, the Court found that because the statements were simply "too important to the dispute [...] to have been accidental", that they were "obviously" inserted by the drafter of the affidavit. The Court made reference to the fact that it was "significant that these material untrue statements" remained in the affidavit "after whatever number of reviews and preparation took place leading up to a significant legal challenge as mounted here".


In considering Apotex' utility allegation, the Court made note of the difference between goals and outcomes that a patent promises: goals may relate to potential uses for the patent, while promises are explicit and define guaranteed or anticipated results from the patent (depending on whether the promise is demonstrated or soundly predicted). Gilead had argued the only promise of the 619 Patent was the offer of efficient oral delivery of tenofovir, while Apotex maintained that the Patent also promised an effective treatment for, among other things, HIV. The Court found that while the goal of the 619 Patent was to improve treatment for HIV, ultimately the promised utility was simply effective oral bioavailability of the parent drug through its prodrug.

In determining the utility of the Patent, Gilead relied solely on demonstrated utility (making no submission on sound prediction) based on laboratory notes as well as two examples stated in the Patent. On this evidence, and after noting that the Court is not bound only by the contents of the 619 Patent when determining demonstrated utility, the Court was satisfied that Apotex's inutility allegation was unjustified.


1. Gilead Sciences, Inc. et al. v. Teva Canada Limited et al., 2013 FC 1270; Bristol-Myers Squibb et al. v. Teva Canada Limited et al., 2013 FC 1271; Gilead Sciences, Inc. et al. v. Teva Canada Limited et al., 2013 FC 1272,

2. Gilead Sciences, Inc. et al. v. Apotex, Inc. et al., 2016 FC 231; aff'd 2016 FCA 140.

To view the original article please click here.

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.