Canada: Pharma In Brief - Patents Found Obvious; Subsequent Appeal Moot

Cases: Janssen Inc v Teva Canada Limited and Canada (Health), 2015 FC 184 (T-2195-12); and Janssen Inc v Teva Canada Limited and Canada (Health), 2015 FC 247 (T-2194-12) aff'd 2015 FCA 36

Drug: VELCADE® (bortezomib)

Nature of case: Prohibition proceedings pursuant to PM(NOC) Regulations

Successful Party: Teva Canada Limited

Dates of decisions: February 16, 2015 for T-2195-12 and February 26, 2015 for T-2194-12

Summary

Janssen Inc (Janssen) brought two Applications pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations for orders prohibiting the Minister of Health from issuing a Notice of Compliance to Teva Canada Limited (Teva) in respect of bortezomib (VELCADE®) until the expiry of Canadian Patent No. 2,203,936 ('936 Patent) and 2,435,146 ('146 Patent). The Applications were heard before Justice Barnes of the Federal Court.

The only issue before the Court in both proceedings was whether Teva's allegation of invalidity based on obviousness was justified. In T-2194-12, Justice Barnes held that the '936 Patent, which pertains to the compound bortezomib, was obvious because it was a selection from a genus but lacked "a special property of an unexpected character" or "a substantial advantage over the genus from which it is selected". Moreover, the genus patent contained a "clear roadmap to bortezomib", which rendered the '936 Patent obvious.

In T-2195-12, Justice Barnes held that the '146 Patent, which pertains to bortezomib ester, was obvious because the "choice of a routinely used stabilizing method and the selection of a routinely used bulking agent to formulate bortezomib cannot be said to be inventive."

Accordingly, the Federal Court refused to grant Janssen's Applications for prohibition orders in both proceedings.

Obviousness

With respect to the allegations of obviousness, the Federal Court referred to the four-part test set out by the Supreme Court of Canada in Sanofi-Synthelabo Canada.  

The '936 Patent – T-2194-12 – 2015 FC 247

The '936 Patent is the compound patent for bortezomib.

Justice Barnes held that the inventive concept of the claim at issue was not limited to the compound bortezomib. This is because throughout the '936 Patent the compounds of the invention are discussed with respect to their function as proteasome inhibitors. Whereas the inventive concept of the '936 Patent includes functionality, it does not include potency or selectivity.

Teva argued, and Justice Barnes agreed, that the '936 Patent amounts to a selection from the '904 Patent, which is a genus patent that discloses bortezomib. Justice Barnes held that a "person of skill is not doing anything inventive when he chooses options provided in a prior patent to build a molecule that he expects will work." Furthermore, bortezomib does not possess "a special property of an unexpected character" or "a substantial advantage over the genus from which it is selected".

The '936 Patent was also considered obvious because the use of a pyrazinecarbonyl group for N-terminal protection of peptides was known in the prior art, and, regardless, most any blocking group would work due to proteases being relatively insensitive to the precise identity of the N-terminal blocking group.

Justice Barnes also held that Janssen's course of conduct was not "arduous or fraught with difficulty" and "was a matter of routine benchwork." Janssen "simply selected a blocking group from among a group of available choices with an expectation that it would provide the requisite protection to the active part of the bortezomib molecule."

Justice Barnes held Teva's allegation of obviousness was justified and refused to issue a prohibition order.

The '146 Patent – T-2195-12 – 2015 FC 184

The '146 Patent is the patent relating to bortezomib ester. Janssen and Teva disagreed as to the qualifications of the POSITA. Janssen argued that within a single patent, "specific claims can be parsed from the whole and construed in isolation from the rest of [the] patent by persons of skill with varying qualifications." Justice Barnes rejected this approach and held that since patents are to be read as a whole and a POSITA may have composite skills, the POSITA in the instant case has the composite expertise of both a formulator and a medicinal chemist.

With respect to the inventive concept of the '146 Patent, Janssen asserted the inventive concept of the '146 Patent as the identification of a pharmaceutically stable formulation of bortezomib that also readily achieves a pharmaceutically active form upon dissolution. Teva characterized the inventive concept as the lyophilized mannitol ester of bortezomib yielding a suitable stable formulation acceptable for use in pharmaceutical preparations. Justice Barnes preferred Teva's submissions on  this point.

Janssen argued that a "very wide gulf" existed between the prior art and the invention of the '146 Patent. This was because a POSITA would not find it self-evident that bortezomib would form a stable ester with mannitol, nor would it be self-evident that it would be possible to obtain a workable formulation. On the other hand, Teva argued that it was self-evident that the stability of bortezomib could be enhanced by preparing a lyophilized formulation with mannitol.

Justice Barnes recognized that there were but a few avenues to try to arrive at the invention of the '146 Patent, however this was not conclusive of an obvious invention. Instead, Justice Barnes held that the invention in the '146 Patent was obvious because the "choice of a routinely used stabilizing method and the selection of a routinely used bulking agent to formulate bortezomib cannot be said to be inventive." Justice Barnes held that a POSITA would choose lyophilization - as the inventor did - and that mannitol was one of only a few bulking agents to try. Moreover, there was no "teaching away" from either lyophilization or mannitol. Thus, the discovery of the invention in the '146 Patent was "routine" and "there was no reason to believe that what was tried was unlikely to work." Accordingly, there were no material differences between what was known in the prior art and what was claimed in the '146 Patent.

Justice Barnes held Teva's allegation of obviousness was justified and refused to issue a prohibition order.

Janssen's appeal

Janssen appealed from T-2194-12, which is the proceeding that pertained to the '936 Patent. This appeal was dismissed on the basis of mootness as previously reported in our Pharma in Brief dated February 20151.  

Link to decisions:

The Federal Court T-2195-12 decision may be found here.

The Federal Court of Appeal mootness decision may be found here.

Pharma in Brief re Federal Court of Appeal mootness decision may be found here.

Footnote

1 Our summary of the appeal decision predated the summary of the underlying Federal Court decision because the public reasons for judgment in T-2194-12 were released after the appeal decision.

Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global legal practice. We provide the world's pre-eminent corporations and financial institutions with a full business law service. We have more than 3800 lawyers based in over 50 cities across Europe, the United States, Canada, Latin America, Asia, Australia, Africa, the Middle East and Central Asia.

Recognized for our industry focus, we are strong across all the key industry sectors: financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and life sciences and healthcare.

Wherever we are, we operate in accordance with our global business principles of quality, unity and integrity. We aim to provide the highest possible standard of legal service in each of our offices and to maintain that level of quality at every point of contact.

Norton Rose Fulbright LLP, Norton Rose Fulbright Australia, Norton Rose Fulbright Canada LLP, Norton Rose Fulbright South Africa (incorporated as Deneys Reitz Inc) and Fulbright & Jaworski LLP, each of which is a separate legal entity, are members ('the Norton Rose Fulbright members') of Norton Rose Fulbright Verein, a Swiss Verein. Norton Rose Fulbright Verein helps coordinate the activities of the Norton Rose Fulbright members but does not itself provide legal services to clients.

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
Smart & Biggar/Fetherstonhaugh
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Smart & Biggar/Fetherstonhaugh
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