Canada: Federal Court Holds Compound Patent To Cinacalcet To Be Anticipated And Obvious

The Federal Court released its reasons in Amgen Canada Inc v Mylan Pharmaceuticals ULC on November 3, 2015. The Court dismissed an application commenced under the Patented Medicines (Notice of Compliance) Regulations (NOC proceeding) by pharmaceutical company Amgen for an order prohibiting the Minister of Health from issuing a market authorization (notice of compliance) to Mylan for its version of Amgen's calcimimetic drug SENSIPAR®.    These reasons are a rare instance of the Federal Court invalidating a patent covering a chemical compound on prior art grounds. The Court's judgment also serves as a reminder that verifying the predicted properties of previously disclosed compounds is undeserving of a patent.


Canadian Patent No. 2,202,879 (the 879 Patent) disclosed and claimed a very large number of compounds, including the cinacalcet molecule and its pharmaceutically acceptable salts.  Claim 5 was directed to cinacalcet, the medicinal ingredient in SENSIPAR®.

Mylan alleged that the 879 Patent was invalid for anticipation, obviousness and obviousness-type double patenting.  Amgen acknowledged in the NOC proceeding that a prior art patent (the 828 Patent) disclosed cinacalcet generically as part of a claimed genus of over a trillion structures, but Amgen argued that because the inventors of the 828 Patent had neither made nor tested cinacalcet, claim 5 of the 879 Patent was the "selection invention" of cinacalcet from the compounds disclosed in the 828 Patent.  This selection, Amgen argued, was the "complete answer" to Mylan's invalidity allegations.  

Cinacalcet Not a Selection Invention

The Federal Court disagreed that cinacalcet and the 879 Patent as a whole were selection inventions.  Justice Phelan reiterated that a selection patent does not differ from any other type of patent, but he held that neither the 879 Patent nor evidence submitted by Amgen supported that the invention of the 879 Patent was a selection: cinacalcet simply did not differ qualitatively or quantitatively from other compounds disclosed in the 828 Patent.  In so doing, the Federal Court reaffirmed the principle that it is not an invention to make and test compounds that were previously disclosed, even generically or as part of an enormous class, if the selected species do not have unique and unexpected properties.


Having found that cinacalcet did not have novel properties, the Federal Court held that the prior art 828 Patent anticipated claim 5 of the 879 Patent.  Relying extensively upon Mylan's experts, the Court concluded that there was no inventive difference between the 828 Patent and cinacalcet.  Mylan's experts had opined that a skilled person would have made cinacalcet "as part of a routine development based solely on the teaching of the 828 Patent."  Specifically, the skilled person had to synthesize and test at most 200 compounds to arrive at cinacalcet, and this testing was mechanical.  On these grounds, the Court concluded that cinacalcet was not novel over the class of compounds disclosed in the prior art.    


On the issues of obviousness and obviousness-type double patenting, the Federal Court held that cinacalcet was not inventive and that claim 5 was not patentably distinct from the invention previously disclosed in the 828 Patent.  Relying again on Mylan's experts, the Court concluded that it would have been obvious to try to obtain cinacalcet because a skilled person would only need to make and test 200 compounds which, on the evidence, was easy and mechanical.  The simple verification that cinacalcet had the properties described or predicted in the prior art did not make it inventive.

Practical Implications

Practically speaking, Amgen Canada v Mylan Pharmaceuticals ULC highlights the crucial role that expert evidence plays in the Court's assessment of prior art disclosures.  The Court's reasons also confirm that the generic disclosure of compounds as part of a large prior art class will anticipate the alleged invention of a compound within that class, unless the claimed compound has unique and unexpected properties.  Moreover, the Federal Court's conclusion on the evidence that making and testing 200 compounds was simple and mechanical illustrates that an alleged invention may be obvious to try, and ultimately uninventive, if it only involves verifying predicted properties through well-known and easy tests.   

Read the Federal Court Reasons for Judgment [PDF].

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