Canada: Torys Successfully Defends Patents For Viagra® And Lipitor®

Last Updated: October 12 2007

Article by Andrew Bernstein, Kamleh Nicola, Andrew Shaughnessy and Peter Wilcox

Torys lawyers have successfully represented Pfizer in two cases before the Federal Court of Canada, defending allegations against patents covering Viagra and Lipitor.

The Viagra® Decision: If It’s Only Worth A Try, It’s Not Obvious; Swiss-Type Claims Are For The Use Of The Medicine

In the Viagra case, the patent covered the use of sildenafil (the active ingredient in Viagra) for the treatment of erectile dysfunction. Apotex had alleged that the claims were invalid as being obvious, anticipated, broader than the invention, and were not claims to the use of the medicine.

Corresponding patents in the United Kingdom and other jurisdictions had been found invalid on the basis of obviousness, and the Canadian case turned on this very issue. Justice Mosley rejected the obviousness attack. He reinforced the value of inventions to society and reaffirmed that obviousness is a difficult test to satisfy. He considered all the relevant factors, including the teaching of the prior art as well as secondary indicia such as the surprise that accompanied sildenafil’s launch, its subsequent wide use and acceptance, and commercial success. The Court concluded that the most that could be said was that the prior art suggested that the class of drugs to which sildenafil belonged might have benefit in treating impotence (i.e., that the class of compounds might be “worth a try”).

Justice Mosley recognized that inventions do not come out of the blue, but are based on the body of work in the prior art and on incremental progress; that is, they are part “deductive science and part luck,” a standard consistent with Canadian case law, which holds that invention can arise equally through empirical research or lucky chance and inspiration.

Under Canadian law, a solution to a problem that might be “worth a try” is not obvious. This is particularly so when, as in this case, all the experts who were working in closely related fields could not answer the question, “If it was so obvious, why didn’t you do it?”

Another notable aspect of Justice Mosley’s decision is the way he treated the so-called Swiss-type claims. While typical-use claims are often drafted to read “the use of compound A for the treatment of condition B,” Swiss-type claims read “the use of compound A for the manufacture of a medicament for the treatment of condition B.” Whether or not these are “claims for the use of the medicine,” which entitles a patentee to assert these claims in Patented Medicines (Notice of Compliance) Regulations litigation, had been an unsettled question under Canadian law. Justice Mosley had no difficulty concluding that, “taking a practical approach to [claim] interpretation,” the Swiss-type claims were “claims for the use of the medicine” and entitled to the benefit of the protection of the Regulations.

The other validity allegations were also found not to be justified. As a result, Apotex is prohibited from obtaining marketing approval for its generic version of Viagra until after the patent expires in 2014. The decision is subject to appeal.

Lipitor®: Use Of Patented Intermediate In India Infringes Canadian Patent

In the Lipitor case, Ranbaxy Laboratories had alleged non-infringement of the patent covering crystal Form I of atorvastatin calcium. The dispute centred on the intermediates used in the process to make Ranbaxy’s active pharmaceutical ingredient. Justice Snider held that the intermediates included all of the elements of the claims.

Ranbaxy argued, however, that its product would be made in India and therefore the use of the patented intermediates would not infringe the Canadian patent. The issue turned on the application of the so-called Saccharin Doctrine. In the Saccharin case (a U.K. case), the defendant made saccharin in a foreign country, employing a certain process and intermediate. Saccharin Corp. owned a U.K. patent covering the process to make the intermediate. The defendant made the intermediate using the patented process, then converted the intermediate to saccharin and imported the saccharin into the United Kingdom.

Even though the process was carried out entirely outside the United Kingdom, the Court held that the patentee is deprived of some part of the invention when the saccharin (made using an infringing process) is imported and that the defendant had infringed the patent.

In the Lipitor case, Ranbaxy argued that the Saccharin Doctrine did not apply and that its application would require an “extension of a legal principle.” Ranbaxy argued that the Saccharin Doctrine is limited to process claims. It went on to argue that, as the intermediate in this case was covered by a product claim and not a process claim, there could be no infringement. Justice Snider rejected this argument and upheld the application of the Saccharin Doctrine in Canada, finding that there was no reason to limit the application of the Saccharin Doctrine to process claims. She concluded that the focus of the analysis was on whether the patentee had been deprived of any part of the invention.

This decision reaffirms the application of the Saccharin Doctrine in Canada. Ranbaxy is prohibited from obtaining marketing approval for its generic version of Lipitor until the expiry of the patent in 2016. The decision is subject to appeal.

As a result of this decision, pharmaceutical manufacturers, particularly generic drug manufacturers, will not be allowed to avoid infringement of Canadian patents by using patented intermediates or patented processes offshore, then importing the active ingredient or finished product to Canada. Like the Viagra decision, the Lipitor decision is further recognition of the importance of inventions.

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 Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
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
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration
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 you may opt out by clicking here

    Terms & Conditions and Privacy Statement

    Mondaq.com (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 www.mondaq.com

    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 Mondaq.com’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.

    Disclaimer

    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.

    Registration

    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.

    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 unsubscribe@mondaq.com 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.

    Cookies

    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.

    Links

    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.

    Mail-A-Friend

    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.

    Emails

    From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

    *** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

    Security

    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 webmaster@mondaq.com.

    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 EditorialAdvisor@mondaq.com.

    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 enquiries@mondaq.com.

    If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.

    By clicking Register you state you have read and agree to our Terms and Conditions