Canada: Pharmacapsules @ Gowlings - January 20, 2012 - Volume 11, Number 1

Edited by Jennifer L. Wilkie and Isabel Jaen Raasch.

Apotex Inc. v. sanofi et al., December 6, 2011, 2011 FC 1486, Plavix

On December 6, 2011, the Federal Court granted Apotex's impeachment action in respect of the '777 Patent, which relates to PLAVIX®. The Court declared the claims of the '777 Patent to be invalid.  As a consequence of the declaration of invalidity, the relief sought in sanofi's infringement action, heard at the same time, was dismissed. 

This was Apotex's second validity challenge to the '777 Patent.  In a previous PM(NOC) Proceeding,  Apotex' allegations of invalidity were found to be unjustified by all three levels of the Canadian courts. Of significance the validity of the '777 Patent had been upheld by the Supreme Court of Canada in 2006. The Court there had affirmed the decisions below that Apotex's allegations of anticipation, obviousness and double patenting were unjustified.  

In the impeachment proceeding, the Federal Court rejected Apotex' allegations that the '777 Patent was invalid for lack of novelty, insufficient disclosure, overbreadth and double patenting.  However, the Court held that the '777 Patent was invalid since it lacked utility. Further, in obiter, the Court stated that, if necessary, that it would have found that the patent was obvious – in direct contradiction to the Supreme Court decision on this issue in the previous litigation.

The finding in favour of impeachment was made on the allegation of inutility, and in particular lack of a sound prediction. The Court held that the '777 Patent "promised" that clopidogrel could be used in humans. 

The Court then held that although the patentee had an ample factual basis and sound line of reasoning for the utility, there was insufficient disclosure of these two elements in the patent specification. This finding was made despite the fact that the Court had held that sanofi had met its statutory disclosure requirement.

The Court also held that if the '777 Patent had been valid, it would have held that Apotex infringed it.

The full text of this decision can be accessed at:

"http://decisions.fct-cf.gc.ca/en/2011/2011fc1486/2011fc1486.html"

Allergan Inc. v. Canada (Health), November 17, 2011, 2011 FC 1316, Combigan:

This proceeding under the NOC Regs dealt with two patents covering Allergan's COMBIGAN product. Crampton J. granted an order of prohibition with respect to the more recently issued of the two patents (the '764 Patent) , finding that it was not obvious. In obiter, he then denied Allergan's request for a prohibition order regarding the more recent of the two patents (the '626 Patent), holding that Sandoz's product monograph would not induce infringement of the patent.

Sandoz's only attack on the '764 Patent was that it was invalid as being obvious. While using the Sanofi framework in conducting his obviousness analysis, Crampton J. rejected Sandoz's argument that the inventive concept must be determined solely from the language in the claims.  A court may only look beyond the claims in determining the inventive concept when the claims are confined to a bare chemical formula or to a selection patent.  Crampton J. found that it is "both necessary and permissible" to look to the whole of the disclosure in determining the inventive concept in cases where the inventive concept is not readily discernible from the claims themselves.

Sandoz alleged that they would not infringe the '626 Patent.  The issue before the Court was whether Sandoz's product monograph would induce infringement.  The three-part test for inducement from AB Hassle v Canada ([2002] 3 FC 221) was followed.  It was found that infringement was likely to occur if the NOC was issued, however, Allergan failed to establish that Sandoz's product monograph would influence doctors and pharmacists to the point that the infringement would not take place without the monograph, and thus did not satisfy part two of the test.

Despite the above finding, Crampton J. addressed Sandoz's argument that the '626 Patent was invalid for lack of utility. Crampton J. quickly dismissed this allegation, finding that the '626 Patent exhibited both demonstrated and soundly predicted utility.

The full text of this decision can be accessed at:

"http://decisions.fct-cf.gc.ca/en/2011/2011fc1316/2011fc1316.pdf"

Teva Canada Limited v. Wyeth LLC, December 9, 2011, 2011 FC 1442, venlafaxine

This was a successful motion by the defendants to dismiss the plaintiff's action for s.8 damages following a recent decision by Hughes J. (2011 FC 1169) in which he held that the plaintiff Teva was not permitted to continue ratiopharm's claim for s. 8 damages following their merger.

The motion was allowed despite the fact that the plaintiffs had filed an appeal. This was because Hughes J. was sceptical that there would be adequate time to prepare for the February 11, 2013 trial date once all appellate rights had been exhausted, and because the backlog in the courts has created a need to give consideration to other litigants seeking trial dates.

The full text of this decision can be accessed at:

"http://decisions.fct-cf.gc.ca/en/2011/2011fc1442/2011fc1442.pdf"

Janssen Inc. v. Teva Canada Limited, December 15, 2011, 2011 FC 1480, levofloxacin:

This was a motion to add four parties as plaintiffs to the action. By way of history, Janssen Inc. and Daiichi Limited were successful in a 2006 infringement action against Novopharm (now Teva). Prior to this decision, a bifurcation order had been issued that separated the issues of patent invalidity and infringement from that of monetary remedies. The parties who sought to be joined to the remedies action were related to the plaintiff Janssen Inc. and were involved in either the manufacture, sale or distribution of levofloxacin. Their motive for joining the action as plaintiffs was the potential for recovery of damages under s. 55(1) of the Patent Act as "persons claiming under the patentee".

Hughes J. found that a determination of whether these parties were in fact "persons claiming under the patentee" could only be determined following a trial, and that this trial might require discovery, further evidence, expert evidence and submissions from the parties regarding this new evidence. He distinguished prior case law (2004 FCA 57) where such a motion was allowed on the basis that in the prior case law the proceedings were still at an early stage, and thus the additional evidence and discovery required could more easily be accommodated.

Hughes J. noted that, if he were to join any of the new parties, their claim(s) for damages would be limited to six years from the filing of the present motion, which took place on August 30, 2011. Given that Teva's infringement was found to have taken place between November 29, 2004 to November 17, 2006, the effect of the limitation period would have been to preclude the new plaintiffs from approximately nine months of damages.

Hughes J. also made it clear that any or all the four parties seeking joinder were free to start a new action for damages at this time.

The full text of this decision can be accessed at:

http://decisions.fct-cf.gc.ca/en/2011/2011fc1480/2011fc1480.html

Merck Frosst Canada & Co. v. Apotex Inc., November 25, 2011, 2011 FCA 329, norfloxacin:

This appeal dealt with a number of issues relating to s. 8 of the PM(NOC) Regulations. First at issue was the interpretation of the word "pending" in a transitional provision of the 1998 Regulations. The question was whether the 1993 or the 1998 version of the Regulations applied in determining s. 8 damages. The second issue was whether the 1998 Regulations were invalid because they cause retroactive or retrospective effects, or interfere with vested rights, without authorization in the Patent Act. The final question was whether the Federal Court erred in concluding that Apotex suffered a loss as a result of Merck's prohibition application.

The FCA confirmed O'Reilly J.'s trial decision that the prohibition application was pending as of the relevant date for the transitional provision, and thus the 1998 Regulations applied. At this date, the prohibition application had been heard by the Supreme Court but a decision had not yet been released. It was held that an application is "pending" if it "remains alive either at first instance, or on appeal". In this case, it would have been pending until the release date of the Supreme Court's judgment.

The FCA rejected Merck's argument that the 1998 Regulations were invalid because they retrospectively imposed a set of rules that were fundamentally different from those that applied when Merck applied for the prohibition. It was held that the new s. 8 did not revolutionize the substantive law, that the legislative amendment did not deprive Merck of any rights that it previously held, that there is no right to the continuance of the substantive standards in laws and that any change in the law was such that Merck would not have been prejudiced by reliance that Merck may have placed on any part of the 1993 Regulations that was affected by the 2008 amendments.

Merck's submission that the FC erred in concluding that Apotex suffered a loss as a result of the prohibition application was also rejected. The FCA found that there was a sufficient factual basis for the FC to make the factual findings that it did. One of Merck's arguments under this heading was that Apotex could not have acquired norfloxacin from Novopharm under its supply agreement as to do so would have been an contrary to the terms of Novopharm's compulsory licence. This argument was rejected as res judicata and subject to issue estoppel, having been considered by the Supreme Court in its previous consideration of this case ([1998] 2 S.C.R. 193).

The full text of this decision can be accessed at:

http://decisions.fca-caf.gc.ca/en/2011/2011fca329/2011fca329.pdf 

Canadian Generic Pharmaceutical Association v. Canada (Minister of Health) and GlaxoSmithKline Inc., December 15, 2011, 2011 FCA 329, fluticasone furoate:

This appeal affirmed two lower decisions (2011 FC 465 and 2010 FC 1211) where it was held that the CGPA lacked standing to bring the application to dispute the listing of fluticasone furoate on the Patent Register on the basis that it was not directly affected. The FCA affirmed that the FC and the prothonotary both applied the correct legal principles in denying standing.

The CGPA was also denied public interest standing on the basis that it failed to establish that generic manufacturers do not have a reasonable and effective means at their disposal to challenge the listing of a drug on the Register.

For a summary of the decision at the Federal Court, see:

Pharmacapsules @ Gowlings, June 1, 2011 - Volume 10, Number 3 at:
http://www.gowlings.com/KnowledgeCentre/enewsletters/pharmacapsules/HtmFiles/V10N03_20110601.en.html#recent

The full text of the FCA decision can be found at:

http://decisions.fca-caf.gc.ca/en/2011/2011fca357/2011fca357.html

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
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