Canada: Summary Judgment For Impeachment Action Of Viagra Patent Upheld By FCA

Last Updated: January 30 2014
Article by Andrea Berenbaum

On January 22, 2014 the Federal Court of Appeal ("FCA") in Pfizer Ireland Pharmaceuticals v Apotex Inc, dismissed an appeal from the judgment of the Federal Court which granted Apotex's motion for summary judgment in its action to impeach Pfizer's Canadian Patent No. 2,163,446 ("the '446 Patent").

Background

The '446 Patent was previously the subject of an application brought by Pfizer under the Patented Medicines (Notice of Compliance) Regulations ("PM(NOC) Regulations") for an order prohibiting the Minister of Health from granting authorization to Teva (then Novopharm) to market generic sildenafil for the use claimed in the '446 Patent. Those proceedings ultimately resulted in the Supreme Court of Canada ("SCC") in Teva Canada Ltd v Pfizer Canada Inc ("Sildenafil") dismissing Pfizer's application because of its finding that Teva's allegation of invalidity on the basis of insufficient disclosure was justified. In the decision which was initially released, the SCC had held the '446 Patent to be "void" but the original reasons and formal order were subsequently amended in response to a motion brought by Pfizer. (Please click here and here for further details.)

The basis of the SCC's finding in Sildenafil was that the disclosure of the '446 Patent was insufficient because it did not disclose that sildenafil, the active ingredient in ViagraTM, was the compound that had been demonstrated to work in patients.

Motion for Summary Judgment

After the SCC had released its initial decision in Sildenafil, Apotex filed a motion in the Federal Court seeking summary judgment of its action to impeach the '446 Patent.

The motion for summary judgment in the present case was granted by the Federal Court prior to the amendment to the Sildenafil reasons and formal order detailed above was made. In granting the motion, the Federal Court concluded that the determination by the SCC in Sildenafil that the '446 Patent fails to meet the requirement of sufficient disclosure is a legal determination binding on the Federal Court and was dispositive of Apotex's claim in the impeachment action that the '446 Patent is invalid due to insufficiency even if the SCC grants Pfizer's motion and deletes the declaration of invalidity from its judgment. The issue on appeal to the FCA was whether the Federal Court erred in law or misapplied the test for summary judgment in so concluding.

FCA Decision

Following the "long and consistent" line of jurisprudence to the effect that an application for a prohibition order under the PM(NOC) Regulations cannot, as a matter of law, result in a final determination as to the validity or infringement of a patent, the FCA agreed with Pfizer's argument in the present appeal that Sildenafil is based on a particular construction of the '446 Patent which cannot be conclusive for all purposes.

However, the FCA held that Pfizer failed to present evidence establishing a genuine issue for trial as is required of a respondent opposing a motion for summary judgment.

The FCA held in its reasons that

... to establish that there is a triable issue with respect to the construction of the 446 patent, it was incumbent on Pfizer to adduce evidence or to refer to evidence already adduced in this matter. In particular, Pfizer should have adduced or referred to evidence that addresses how the skilled reader would construe the specification, and why that construction casts doubt on the correctness of the construction adopted in [Sildenafil]. The record contains no such evidence.(paragraph 25)

The claims of the '446 Patent included a claim relating to the use of sildenafil for the treatment of erectile dysfunction (ED) and another claim relating to the same use of a compound designated as UK-114,542. In the present case, Pfizer pointed to evidence that UK-114,542 was in fact tested before the Canadian filing date and found to be useful for treating ED. However, the FCA asserted that

... what the patent discloses is that as of the filing date studies had confirmed that one of the compounds in the especially preferred group induces penile erection in important (sic) males. There is no disclosure that UK-114,542 was tested, and Pfizer has adduced no evidence that is capable of establishing that the skilled reader should have discerned from the specification that it was tested. (paragraph 26)

Accordingly, the FCA concluded the evidence that UK-114,542 was tested is not capable of establishing a genuine issue for trial on the question of the sufficiency of the disclosure.

In the present decision, the FCA also declined to resolve the debate regarding whether the relevant date for determining the sufficiency of the disclosure is the filing date of the Canadian patent application or the date on which the patent application becomes public. Accordingly, it appears there is presently still uncertainty as to this issue in Canada.

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.

Authors
Andrea Berenbaum
 
In association with
Related Topics
 
Related Articles
 
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 (you must 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

Mondaq.com (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 www.mondaq.com

To Use Mondaq.com 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.

Disclaimer

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.

General

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