Canada: Pharma In Brief - Federal Court Of Appeal Upholds Prohibition Order: Relevant Date For Assessing Obvious-Type Double-Patenting Is Considered

Case: Mylan Pharmaceuticals ULC v Eli Lilly Canada Inc., 2016 FCA 119 (Court File No. A-47-15), aff'g 2015 FC 17

Drug: CIALIS® (tadalafil)

Nature of case: Appeal from application for prohibition granted pursuant to section 6 of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)

Successful party: Eli Lilly Canada Inc.

Date of decision: April 20, 2016


Eli Lilly Canada Inc. (Lilly) markets tadalafil in Canada under the name CIALIS® for the treatment of erectile dysfunction (ED). Mylan Pharmaceuticals ULC (Mylan) sought approval for a generic version of tadalafil.

The Federal Court prohibited the Minister from issuing a Notice of Compliance (NOC) to Mylan in respect of tadalafil, finding that Mylan had not justified its allegations of obviousness-type double-patenting or lack of sound prediction. The Court of Appeal upheld the decision.

Obviousness-type double-patenting

Canadian Patent No. 2,226,784 (784 Patent) is listed on the patent register in respect of CIALIS®. It claims tadalafil and 3-methyl tadalafil for use in the treatment of ED. The 784 Patent has a priority date of July 14, 1995, a Canadian filing date of July 11, 1996, and a publication date of February 6, 1997.

Lilly owns another patent—Canadian Patent No. 2,181,377 (377 Patent)—which claims tadalafil and the use of tadalafil in the treatment of various disorders, but not treatment of ED specifically. It had a priority date of January 21, 1994 and a Canadian filing date of January 19, 1995, both of which precede the priority date of the 784 Patent in issue.

The Court of Appeal focused on two issues in respect of obviousness-type double-patenting: claims construction and the correct date for the analysis.

The Court of Appeal found that the Federal Court erred in referring to the specification when construing the claims of the 377 Patent, holding that the rules of construction preclude reference to the specification when the claims are clear. As the 377 Patent unambiguously claimed tadalafil without any reference to its use as a PDE V inhibitor, no reference to the specification was required. The Court of Appeal ultimately found that the error had no effect, as it imposed a higher burden on Lilly.

As to the correct date for conducting the obviousness-type double-patenting assessment, the Court of Appeal identified three possible dates: (1) the priority date of the earlier 377 Patent (Lilly's preferred date); (2) the priority date of the 784 Patent; or (3) the publication date of the 784 Patent (Mylan's preferred date).  

The Court of Appeal rejected Mylan's preferred date finding that it would be inappropriate to use any date after the claim date of the impugned patent (in this case, the 784 Patent). The Court of Appeal reasoned that section 28.3 of the Patent Act limited the prior art to be considered in a classical obviousness analysis to prior art published before the claim date. There was no principled basis to permit prior art after the claim date to be considered in the context of an obviousness-type double-patenting analysis, but not classical obviousness.

As between the two remaining dates, the Court of Appeal did not determine which date was appropriate.  It found that there was no change in the common general knowledge between the two priority dates. Therefore, at either date, the claims of the 784 Patent would not have been obvious.

Notably, in a separate proceeding, Apotex similarly unsuccessfully alleged—among other things—that the 784 Patent was invalid for obviousness-type double-patenting. Apotex alleged that the Canadian filing date of the 784 Patent was the relevant date for the inquiry. Neither the Federal Court nor the Court of Appeal in the Mylan case considered this date in their analyses. In the Apotex decision, Justice Gleason held that the correct date was one of the priority dates of the two patents. However, she did not determine which was the correct date, as she came to the same result for both. The Apotex decision is currently under appeal and will be heard on May 5, 2016.

Sound prediction

Mylan also argued that the oral administration of 3-methyl tadalafil for treatment of ED was not soundly predicted because there was no disclosure of the oral bioavailability of 3-methyl tadalafil in the patent.

The Federal Court did not consider whether the utility of 3-methyl tadalafil had been soundly predicted, as 3-methyl tadalafil was encompassed by a Markush claim that encompassed tadalafil, for which the utility was soundly predicted.  The Federal Court reasoned that it was unnecessary to consider whether each compound would work. The Court of Appeal found that the Federal Court judge erred and that a Markush claim requires that each compound in the claimed class have utility. However, the error was of no consequence because there was evidence before the Judge that the utility of 3-methyl tadalafil had been soundly predicted.

Link to decisions:

Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., et al., 2016 FCA 119

Federal Court decision: Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 17

Apotex decision: Eli Lilly Canada Inc. v. Apotex Inc, 2015 FC 875

About Norton Rose Fulbright Canada LLP

Norton Rose Fulbright is a global law firm. We provide the world's pre-eminent corporations and financial institutions with a full business law service. We have more than 3800 lawyers and other legal staff based in more than 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.

For more information about Norton Rose Fulbright, see

Law around the world

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
Aird & McBurney LP
Bereskin & Parr LLP
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
Aird & McBurney LP
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