Canada: Pharma In Brief - Canada: Federal Court Issues Prohibition Order In Respect Of Zoledronate [ACLASTA®]

Case: Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited, 2013 FC 283

Drug: ACLASTA® (zoledronate)

Nature of case: Prohibition Application pursuant to s. 6 of the PM(NOC) Regulations

Successful party: Novartis Pharmaceuticals Canada Inc.

Date of decision: March 19, 2013


Novartis Pharmaceuticals Canada Inc. ("Novartis") brought an application pursuant to s. 6 of the Patented Medicines (Notice of Compliance) Regulations for an order prohibiting the Minister of Health from issuing a notice of compliance to Teva Canada Limited ("Teva") in respect of Teva's proposed zoledronate tablets until the expiry of Canadian Patent Nos. 1,338,895 (the "859 Patent") and 1,338,937 (the "937 Patent"). Zoledronate (sold by Novartis under the brand name ACLASTA®) is used, inter alia, to treat osteoporosis.

The '859 Patent is directed to a class of heteroarylalkane diphosphonic acids, of which zoledronate is a member. The '859 Patent does not contain a specific claim to zoledronate. Teva alleged that the '859 Patent was invalid for obviousness, lack of utility and insufficiency. The '937 Patent is directed to zoledronate and pharmaceutical compositions containing zoledronate. Teva alleged the '937 Patent is invalid for obviousness, lack of utility, insufficiency, and overbreadth.

The Court held that Teva's allegation of lack of utility in respect of the '859 Patent was justified, as "there is nothing in the description of the '859 Patent that any witness said would establish a basis for sound prediction that all members of the class would have utility." However, Justice Hughes found that Teva's allegations in respect of the '937 Patent were not justified and issued a Prohibition Order.

Claims in Issue

Both the '859 Patent and the '937 Patent were filed prior to October 1, 1987 and are thus considered "Old Act" patents. At filing, the patents had overlapping claims and would have been subject to conflict proceedings, however, the patent owners resolved amongst themselves that the '859 Patent would contain the genus claims and the '937 Patent would contain claims specific to zoledronate.

Novartis asserted Claim 14 of the '859 Patent, which the Court construed as claiming "a class of some 1.2 million compounds all sharing a selection of molecules at the R1 and R2 positions placed on a biphosphonic backbone; zoledronate is but one of such compounds. "The '937 Patent contains only two claims, both of which were asserted by Novartis. Justice Hughes construed claim 1 as claiming the compound zoledronate and claim 2 as claiming a pharmaceutical composition containing zoledronate and pharmaceutical excipients.


As both patents are "Old Act" patents, obviousness is to be assessed as of the date of invention. The date of invention for the '859 Patent was held to be no earlier than the priority application, wherein the 'class' of compounds was articulated. The date of invention for the '937 Patent was held to be July 1987, the date on which the inventors made and tested zoledronate in rats.

(i) Inventive Concept

The Court held that the inventive concept of the '859 Patent was "a family of (about 1.2 million members) novel compounds containing a 5-membered, ring, which is connected to the geminal BP [bisphosphonate] carbon by a one-carbon linker (-CH2-). These BP's have biological activity as calcium complex formers and inhibit bone resorption."

Although the claims of the '937 Patent are directed only to zoledronate, the description of the '937 Patent discusses a larger class of compounds. Consequently, the Court considered whether the inventive concept of the '937 Patent could be construed as being broader than just zoledronate. Justice Hughes distinguished the Supreme Court's recent VIAGRA decision, noting that as the '937 Patent only contained claims that related to a single compound the inventive concept could be limited to zoledronate "as a useful inhibitor of bone resorption in rats and that, as such, is suitable for use as a medicament in the treatment of diseases in humans associated with impairment of calcium metabolism."

(ii) Differences between the State of the Art and the Inventive Concept

Teva argued that, at the relevant dates, it was known that bisphosphonate compounds inhibited bone resorption. Teva's experts opined that, based upon the state of the art, the person of skill in the art would have known that members of the class of compounds would have bone resorption inhibition activity. They further opined that the person of skill in the art would know how to make zoledronate and know that it would have bone resorption inhibition activity.

Justice Hughes dismissed Teva's experts' opinions as being based on hindsight. The Court held that there was "too much uncertainty" as to whether particular chemical structures would be useful. Consequently, it was not "self evident" that what is claimed in either patent ought to work.


(i) '859 Patent

The evidence showed that the inventors named in the '859 Patent tested two compounds before the priority application was filed, neither of which was zoledronate, and only one of which falls within the scope of claim 14 of the '859 Patent. The inventors went on to make and test zoledronate prior to the filing of the Canadian application.

The Court held that the question in respect of utility was whether the testing of a few compounds could establish the utility for the claimed class. Justice Hughes found that "there is nothing in the description of the '859 patent that any witness said would establish a basis for sound prediction that all members of that class would have utility. In brief, the state of the art was at the empirical stage where compounds would have to be assessed individually. There was no consensus in the state of the art at the time that there was a basis for drawing conclusions as to a class." On this basis, the Court found Teva's allegation of invalidity to be justified.

(ii) '937 Patent

Justice Hughes held that the inventors made and tested zoledronate before the filing date and found it to be "useful for the stated purpose namely, a pronounced regulatory action on the calcium metabolism of warm-blooded animals".


The Court noted that Canadian law was not clear as to what the relevant date is for considering sufficiency. After reviewing English and Canadian jurisprudence, Justice Hughes determined that the "most appropriate date for consideration of sufficiency of a Canadian patent is the date of publication". In the case of an "Old Act" patent, this would be the date the patent was granted. In the case of a ""New Act" patent, this would be the date of publication.

For the same reasons as discussed with respect to utility, Justice Hughes found that Teva's allegations of insufficiency in respect of the '859 Patent were justified.

With respect to the '937 Patent, Justice Hughes distinguished the VIAGRA decision, as the claims in this case are directed to a single compound. As a result, the Court held Teva's allegation of insufficiency was not justified. The Court noted that, at the time of filing, the '937 Patent contained additional claims to several compounds. Justice Hughes noted that if sufficiency had been assessed as at the filing date, the Court would have found that the application was no different than that considered by the Supreme Court in VIAGRA, and would have found the allegation of insufficiency justified.

Link to decision:

Novartis Pharmaceuticals Canada Inc. v. Teva Canada Limited, 2013 FC 283

Norton Rose Group

Norton Rose Group is a leading international legal practice. We offer a full business law service to many of the world's pre-eminent financial institutions and corporations from offices in Europe, Asia, Australia, Canada, Africa, the Middle East, Latin America and Central Asia.

Knowing how our clients' businesses work and understanding what drives their industries is fundamental to us. Our lawyers share industry knowledge and sector expertise across borders, enabling us to support our clients anywhere in the world. We are strong in financial institutions; energy; infrastructure, mining and commodities; transport; technology and innovation; and pharmaceuticals and life sciences.

We have more than 2900 lawyers operating from 43 offices in Abu Dhabi, Almaty, Amsterdam, Athens, Bahrain, Bangkok, Beijing, Bogotá, Brisbane, Brussels, Calgary, Canberra, Cape Town, Caracas, Casablanca, Dubai, Durban, Frankfurt, Hamburg, Hong Kong, Johannesburg, London, Melbourne, Milan, Montréal, Moscow, Munich, Ottawa, Paris, Perth, Piraeus, Prague, Québec, Rome, Shanghai, Singapore, Sydney, Tokyo, Toronto and Warsaw; and from associate offices in Dar es Salaam, Ho Chi Minh City and Jakarta.

Norton Rose Group comprises Norton Rose LLP, Norton Rose Australia, Norton Rose Canada LLP, Norton Rose South Africa (incorporated as Deneys Reitz Inc), and their respective affiliates.

On January 1, 2012, Macleod Dixon joined Norton Rose Group adding strength and depth in Canada, Latin America and around the world. For more information please visit

Norton Rose will join forces with Fulbright & Jaworski L.L.P on June 1, 2013, creating Norton Rose Fulbright a global legal practice with significant depth of expertise across the USA, Europe, Asia, Australia, Canada, Africa, the Middle East, Latin America and Central Asia.

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

Click to Login as an existing user or Register so you can print this article.

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
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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 (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

To Use 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.


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.


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