Canada: NOC Proceedings (Intellectual Property Weekly Abstracts Bulletin (Week Of January 6th, 2014)

NOC Proceedings

Failure to Produce Evidence of Development Leads to Adverse Inference on Obviousness

Gilead Sciences Inc. v. Teva Canada Limited, 2013 FC 1270

Bristol-Myers Squibb v. Teva Canada Limited, 2013 FC 1271

Gilead Sciences Inc. v. Teva Canada Limited, 2013 FC 1272

Drug: tenofovir disoproxil

These proceedings, brought pursuant to the NOC Regulations, dealt with two patents. One set of reasons was issued. The application was granted in part.

With respect to the first patent, one claim was at issue, and its inventive concept was held to be the use of the carbonate promoiety disoproxil with the antiviral compound tenofovir. Infringement was admitted if the claim was valid. The Court held that the patent was not anticipated or obvious and the selection-related invalidity assertions were also held to fail. Thus, a prohibition order was granted with respect to this patent.

With respect to the second patent, the parties agreed that the inventive concept was the choice of the fumarate salt form of tenofovir dioproxil. The Court drew an adverse inference from the failure to produce the same sort of historical evidence it produced with respect to the other patent at issue. Thus, the Court held that in the face of an obviousness attack, the failure to produce such evidence leads to the conclusion that the development was routine. Thus, the obviousness challenge was successful.

Prothonotary's Decision Denying Sur-Reply Not Overturned on Appeal

Pfizer Canada Inc. v. Apotex Inc., 2013 FC 1249

Drug: celecoxib

Pfizer appealed an unreported Order mostly denying their request to file two affidavits in sur-reply. These affidavits would be the fifth wave of affidavits in the proceeding. The Court held that the Prothonotary's Order was discretionary, and could only be overturned if clearly wrong. Furthermore, the Court held that the case management Judge should be afforded "elbow room".

The Court held that the Prothonotary's analysis was persuasive, his reasons were cogent, and he did not apply the wrong principle or misapprehend the facts. Thus, the decision was not clearly wrong and the appeal was dismissed.

Reply Affidavits Allowed when New Documents Introduced in Responding Evidence

Allergan Inc. v. Apotex Inc. 2013 FC 1165

Drug: bimatoprost

In this case, there is a partial reversal of evidence. Apotex brought a motion for leave to file reply evidence. Allergan did not oppose parts of the proposed reply. However, this motion was with respect to those portions which were opposed. Allergan argued that the documents relied upon by its experts should have been known to Apotex, in particular due to the fact that Mylan and Cobalt referred to the documents in their NOAs. Apotex argued that there was a paucity of information about Allergan's case in the Notice of Application.

The Court held that it is not possible to know what the other side believes is relevant until it is put in play. "If the expectation is that if any piece of prior art or document is known to a party and they do not refer to it in their evidence then they cannot reply because they knew of it – this is an invitation for a party to include every single piece of known prior art and document so as not to be prevented from commenting on it." The Court held that the need to reply to documents raised for the first time in Allergan's expert affidavits is not case splitting. Thus the reply affidavits were allowed. However, the Court did caution that granting reply is not an invitation to do a further "document dump".

Actions

Infringement and Validity of Automatic Drilling System Patent Determined

Varco Canada Limited v. Pason Systems Corp., 2013 FC 750

This is a patent infringement action. The patent in issue relates to an automatic drilling system. The Court first addressed and rejected the attacks as to credibility made by the Defendants in respect of the inventor. After setting out the development of the invention, the Court construed the claims of the patent, and determined that the Defendants infringed the asserted claims. The Court also concluded that the Defendants are liable for inducing infringement by others. With respect to infringement by exportation, the Court concluded that the method claims are outside the Court's jurisdiction because the evidence established that the parts are manufactured in Canada but shipped in unassembled form, but the product claim is infringed because the sale of the infringing product occurs in Canada.

The Defendants asserted invalidity of the patent on the basis of anticipation, obviousness, inutility, overbreadth, and deemed abandonment/bad faith. The Court found that the prior art cited by the Defendants did not meet the test of either disclosure or enablement for the purposes of anticipation. The Defendants also alleged anticipation by prior use. In particular, the inventor had no ability to test the prototype developed and used a rig owned by a third party for testing. The Court noted that the Defendants have the burden to prove that there was disclosure of the invention that was sufficiently disclosing for the invention to be practiced. The Court found that the Defendants did not meet this burden. The Court noted that there was no evidence of an unconditional sale of the prototype and experimental use is not prior use. Furthermore, the Defendants' witnesses conceded that testing was necessary to determine if the invention would work. While there was no confidentiality agreement, and no evidence at the trial regarding industry practice, the actions of the inventor indicate an intention to keep the product confidential.

The Court found that the claims were not obvious or overly broad. In terms of inutility, the Court noted "[g]iven the evidence as to the operation of the Wildcat and the Pason AutoDriller, and the finding of infringement, the challenge of "inutility" has a false ring." Part of the inutility challenge relates to use of the terms "increase" and "decrease" in pressure in claims 9 and 10. In particular, "increased" was used when "decreased" should have been used, and vice versa. In response to an ex parte application to the Commissioner of Patents (the "Commissioner"), an amendment was permitted to these claims. The Court in a separate proceeding granted judicial review of the Commissioner's decision. In addressing the merits of the allegation of inutility, the Court in the within case concluded that a person skilled in the art would recognize the error and would not be confused or misled, and therefore the allegation of inutility failed. Finally, the Court concluded that the patent was not invalid on the basis of abandonment.

In terms of remedies, the Court noted that the Plaintiffs established a basis for the equitable relief of an accounting of profits, and no inequitable conduct on the part of the Plaintiffs that would prevent the award of this relief. The Court concluded that the remedy of disgorgement of profits is the appropriate remedy in the circumstances of the case, and awarded approximately $53 million to the Plaintiffs. The Court also calculated lost profits/reasonable royalty as an alternative, as well as a reasonable royalty amount as a further alternative. The Plaintiffs requested exemplary/punitive damages, which the Court indicated would have been awarded if damages had been awarded and not the disgorgement of profits remedy "because of the deliberate infringement carried out in the face of advice from Leier and recklessness as to the consequences." Costs were awarded pursuant to Column V of the Tariff.

Other Industry News

Health Canada has published a Guidance for Industry: Management of Drug Submissions.

Health Canada has published a Guidance Document for Industry and Practitioners - Special Access Programme for Drugs.

Health Canada has published a Guidance Document: Schedule A and Section 3 to the Food and Drugs Act.

Health Canada has published a Guidance Document on Post-Drug Identification Number (DIN) Changes.

Health Canada has published a List of Registrars Recognized by Health Canada under section 32.1 of the Medical Devices Regulations (MDR).

Health Canada has published a Guidance document on how to interact with the Natural Health Products Directorate electronically.

CIPO has published its PCT Schedule of Fees for Applications filed on or after January 1, 2014.

About BLG

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
 
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