Canada: Teva Succeeds In Section 8 Bortezomib Action; Infringement Counterclaim Dismissed

On July 18, 2018, Justice Locke of the Federal Court granted Teva's claim for compensation under section 8 of the Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) for losses suffered while market entry of Teva's bortezomib product was delayed by Janssen's applications under the PMNOC Regulations relating to Patents Nos. 2,203,936 (936 Patent) and 2,435,146 (146 Patent). Teva had succeeded on allegations of obviousness in both proceedings: 2015 FC 247 and 2015 FC 184. Janssen markets its bortezomib product as VELCADE.

Millennium Pharmaceuticals (the 936 patentee and licensor under the 146 Patent) and Janssen argued that Teva was not entitled to section 8 damages because Teva would have infringed the 936 Patent, 146 Patent and the Patent No. 2,738,706 (706 Patent). Millennium, Janssen and additional plaintiffs brought a counterclaim for infringement of the same patents. Justice Locke rejected this defence and dismissed the counterclaim, finding that the relevant claims of the 936 Patent and 146 Patent were obvious and the 706 Patent was not infringed: Teva Canada Limited v Janssen Inc and Millennium Pharmaceuticals, Inc, 2018 FC 754.

Compound patent (obviousness)

The 936 Patent is a compound patent with claims covering bortezomib (claim 69) and a group of six compounds including bortezomib (claim 37). Bortezomib is a proteasome inhibitor, used in the treatment of certain blood cancers. It is a boronic acid analog of a dipeptide. The Court concluded that both claims were obvious and that the 936 Patent failed to meet the criteria for a valid selection patent.

According to Justice Locke, bortezomib fell within the scope of compounds identified in a PCT application and, accordingly, the 936 Patent was "effectively a selection patent". While bortezomib was not previously identified and no one had made the selection of its characteristic components, Justice Locke held that the selection of its components was not inventive for a number of reasons, including that it was obvious to try boronic acids as proteasome inhibitors. Justice Locke also held that selection of the components in combination was not inventive, finding that "[t]here are a finite number of possible practical combinations to try, and any of them would have been expected to offer some potency. The testing involved would have been routine and there was nothing inventive in the decision to conduct such testing."

Not a valid selection patent. As part of his obviousness analysis, Justice Locke also concluded that the 936 Patent was not a valid selection patent since the selection is not "in respect of a quality of a special character peculiar to the selected group". There was no evidence that the claimed compounds (including bortezomib) performed better than the other compounds considered or were selected based on the potency testing in the patent.

Commercial success of VELCADE. Justice Locke found that the success of Janssen's commercial product did not impact the obviousness analysis. Bortezomib alone – considered separately from the commercial formulation – "is too unstable to be commercially practical."

Formulation patent (obviousness)

The 146 Patent addressed the challenge of finding "formulations of boronic acid compounds that are conveniently prepared, bioactive when administered, and more stable than free boronic acid."

According to the Court, for the claims at issue, the difference between the state of the art and the inventive concept "is the use of mannitol and lyophilisation to form an ester of bortezomib." Justice Locke found the invention "obvious to try" because "[i]t was obvious to try lyophilisation and, having decided to do so, it was obvious that a bulking agent would be needed. Moreover, it was obvious to try mannitol as the bulking agent." Specifically, Justice Locke addressed the "obvious to try" factors as follows:

  • Lyophilisation was well-known as one of a finite number of known solutions. The skilled person would expect improved stability.
  • Justice Locke discarded much of the inventors' actual course of conduct as of "limited assistance" to the question of obviousness. Moreover, while the inventors tried many different solutions, their work did not appear "arduous or outside the routine".
  • The skilled person would be motivated to try lyophilisation, consistent with an inventor's view that "he would be remiss not to try it." The skilled person would have known, as part of their common general knowledge, that a bulking agent would be required; it would be obvious to try mannitol, which was "one of the most popular".

Commercial success of VELCADE. Similar to the 936 Patent, the commercial success of Janssen's product did not impact the Court's obviousness analysis. The commercial formulation offered improved solubility and dissolution properties that did not form part of the claimed invention.

U.S. CAFC decision not persuasive. The Court's conclusion on obviousness differed from the decision of the U.S. Court of Appeals for the Federal Circuit (CAFC) on the equivalent U.S. patent. Justice Locke did not find the CAFC's reasons persuasive because of differences in (a) the standard required to find invalidity, (b) the definition of the skilled person, and (c) the prior art.

Process patent (infringement)

The 706 Patent claims cover a process for the "large scale" production of "bortezomib or a boronic acid anhydrate thereof". The Court concluded that the processes for manufacturing Teva-bortezomib and Act-bortezomib (relevant as a result of Teva's amalgamation with Actavis) do not infringe the 706 Patent. Justice Locke provided limited details regarding the processes at issue, but indicated that infringement turned on construction issues decided in favour of Teva. This included rejection of Millennium's argument that use of certain solvents referred to in the claims is not essential because the skilled person would have known of alternatives that could be substituted without changing the way the invention works. Justice Locke found them to be essential as the terms used are "clear and unambiguous".

Conclusion

In view of the above findings, Justice Locke granted the section 8 claim (the parties had agreed upon the amount of compensation, which was not disclosed) and dismissed the counterclaim. 

Milllennium et al may appeal, as of right.

The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.

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