Canada: Federal Court Of Appeal Reinterprets Product Specificity Requirements: Patent Listing Is Determined By Patent Claims Construction And Not A Word Match

Last Updated: July 24 2015
Article by Marc Richard and Kelly A. McClellan, PhD.

Most Read Contributor in Canada, October 2018

On July 17, 2015, the Federal Court of Appeal set aside a judgment of the Federal Court that upheld Health Canada's refusal to list Canadian Patent 2,379,329 (the '329 patent) owned by Eli Lilly Canada Inc. on the Patent Register maintained under the PM(NOC) Regulations.1  

A key victory for innovators, the decision restores the principle (and prior practice) that allows listing of patents claiming ingredients not specifically named in the product, so long as a match exists between the claims as construed and the approved product.


Lilly sought to list its '329 patent on the register in relation to Trifexis®, a chewable tablet containing spinosyns and milbemycin oxime for the treatment of heartworm, and flea infestations in domestic dogs, cats and puppies.2 The '329 patent claimed oral formulations containing spinosad, where oral formulation is defined in the disclosure as potentially including many other known parasitic treatments such as "milbemycins".3

In refusing to list the '329 patent on the Register, Health Canada found the mention of milbemycins in the disclosure was insufficient to meet the requirements for listing under paragraph 4(2)(b) of the Regulations.4

Eli Lilly's application for judicial review of that decision was dismissed by the Federal Court.5 In applying the three step test applicable to listing decisions, the Judge accepted the expert evidence and construed the claims as including milbemycin oxime.6 However, the Judge upheld the Minister's refusal because she interpreted the prior Federal Court of Appeal decision in Gilead7 and the product specificity requirements introduced by the 2006 amendments as requiring a perfect word match between ingredients named in the patent claims and the approved therapeutic product.8


Before the Federal Court of Appeal, Lilly submitted the judge erred by failing to apply the claims construction from step 1 to step 3. In doing so, Lilly submitted the Judge imposed a perfect word match between the patent claims and approved product that neither the product specificity requirements nor Gilead required. To the extent that Gilead required a word match, Lilly also submitted that Gilead was wrongly decided.9

In thorough reasons, the Federal Court of Appeal accepted Lilly's submissions and allowed the appeal.

The Panel unanimously agreed that by failing to compare the patent claims as construed with the approved product, the Judge erred in applying the third step of the test applicable to reviews of listing decisions.10


For the majority, Justices Nadon and Boivin found the Trifexis matter was distinguishable from Gilead, where listing was refused since the claims as construed in Gilead did not match the approved product. 

To arrive at this conclusion, Nadon JA rejected the Minister's submission that the Judge erred in her construction of the patent claims at the first step because no guesswork is allowed in pharmaceutical science.11 Instead, Nadon JA upheld the Judge's construction and approach that a patent is to be read through the eyes of a skilled person willing to understand based on expert evidence12

Moreover, Nadon JA reiterated that the principles of claims construction have consistently been applied in prior decisions of the Federal Court of Appeal in reviewing listing decisions.13 In this regard, Nadon JA distinguished Trifexis from Gilead.14  Reviewing both the Federal Court and Federal Court of Appeal decisions, Nadon JA noted the evidence accepted on the patent claims construction did not support a match between the patent claims and the approved product.15

Nadon JA also reconsidered the "product specificity" requirement amendments introduced in the 2006 amendments.  Nadon JA clarified that the purpose of product specificity was only intended to replace former relevancy requirements as understood before 2006 (Tazidime FCA), and thus does not require a word match as that would ignore claims construction.16 


In concurring reasons Justice Dawson concluded that Gilead was wrongly decided.17

Justice Dawson found certain patent claims in the Trifexis appeal were analogous and could not be distinguished from Gilead.18 In agreeing with the majority's result, Dawson JA reiterated that eligibility for listing of the claims does not require each medicinal ingredient be specifically named, but instead requires an inquiry into what the patent claims.19 Dawson JA commented that denying listing of a patent that contains an innovative and useful ingredient is not consistent with the purpose of the PM(NOC) Regulations to regulate the early working exception20, consistent with the majority view.

Eli Lilly Canada Inc. was represented by Gowlings lawyers Jay Zakaib, Jennifer Wilkie and Kelly A. McClellan.


1 Eli Lilly Canada Inc., v Canada (Minister of Health), 2015 FCA 166 (Reasons)

2 Reasons at para 4-5

3 Reasons at para 7-9

4 Reasons at para 13

Eli Lilly Canada Inc., v Canada (Minister of Health), 2014 FC 152 (FC Reasons)

6 FC Reasons at para 68-9

Gilead v Canada (Minister of Health), 2012 FCA 254

8 FC Reasons at para 83-6

Miller v. Canada (Attorney-General), 2002 FCA 370

10 Reasons at para 98

11 Reasons at para 64-7

12 Reasons at para 52-4 and 65

13 Reasons at para 93-4

14 Reasons at para 88

15 Reasons at para 80, 83, 87 and 92

16 Reasons at para 95-6

17 Reasons at para 100

18 Reasons at para 100

19 Reasons at para 106-7

20 Reasons at para 107-8

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.

In association with
Related Topics
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