Canada: Pharma In Brief - Federal Court Of Appeal Relaxes The "Perfect Match" Requirement For Patent Listing Under The Patented Medicines (Notice Of Compliance) Regulations

Case: Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 (Court File No. A-146-14) [Lilly]

Drug: TRIFEXIS® (spinosad/milbemycin oxime)

Nature of case: Judicial review of refusal by the Minister of Health (Minister) to list CA 2,379,329 (the '329 Patent) against TRIFEXIS® pursuant paragraph 4(2)(b) of the Patented Medicines (Notice of Compliance) Regulations, SOR/93-133 (the Regulations)

Successful party: Eli Lilly Canada Inc. (Lilly) (on appeal)

Date of decision: July 17, 2015

Summary

The Minister of Health refused to list a patent on the Patent Register in respect of a fixed-dose combination product because it did not contain a claim for each medicinal ingredient in the approved product. The patentee sought judicial review. A Federal Court judge dismissed the application for judicial review because the claims of the patent did not refer specifically to both medicinal ingredients in the fixed-dose combination product. The Court of Appeal reversed the Minister's decision and held that the patent was eligible for listing on the Patent Register. A majority held that the Court's previous decisions did not require every medicinal ingredient to be recited in the claims — only that they all be claimed. In concurring reasons, a minority held that this case was not distinguishable from an earlier one with a contrary result and declared that the earlier case was wrongly decided.

Analysis

The issue: TRIFEXIS® and the '329 Patent

TRIFEXIS® is a fixed-dose combination of two veterinary antiparasitic medicinal ingredients, spinosad and milbemycin oxime. The manner in which this combination was claimed in the '329 Patent is the pivotal issue in the case. The '329 Patent claims an oral formulation of spinosad. The term "oral formulation", is defined in the description to comprise spinosad alone or in combination with certain classes of other medicinal ingredients. Several suitable classes are given as examples, including "milbemycins". The second medicinal ingredient of TRIFEXIS®, milbemycin oxime, is a member of that class but is not mentioned by name. Lilly sought listing of the '329 Patent under paragraph 4(2)(b) of the Regulations.

At first instance and in the Court of Appeal, this matter turned largely on interpretations of the Gilead case.1 Gilead concerned claims to the medicinal ingredients and formulation of COMPLERA® (tenofovir disoproxil fumarate/emtricitabine/rilpivirine), a triple-combination drug. In that case, the Court of Appeal accepted the Federal Court's construction of the relevant claims as "combinations and formulations of two medicinal ingredients plus a third one of the NNRTI class that could possibly include but is not specifically rilpivirine". It concluded that these claims were insufficiently product-specific because they did not name the medicinal ingredient, but only the broad class of compounds. Gilead's patent was denied listing under paragraphs 4(2)(a) and 4(2)(b).

In the Federal Court, Bédard J construed the relevant claims of Lilly's '329 Patent to be directed to formulations of spinosad that include other active ingredients such as milbemycin oxime. In her opinion, she was bound by Gilead to find that these claims did not achieve the degree of product specificity required by paragraph 4(2)(b). She reached this conclusion because she interpreted certain statements in Gilead to require that every medicinal ingredient of a combination drug must appear in an eligible claim in order to achieve a "perfect match".

On appeal, Lilly argued that Bédard J correctly construed the '329 Patent but misapplied paragraph 4(2)(b). The Minister argued that the '329 Patent was ineligible for listing because the claims did not include milbemycin oxime.

The Court of Appeal upheld Bédard J's construction of the relevant claims. The decisive question thus became whether those claims met the threshold of product specificity required by paragraph 4(2)(b).

The majority's reasons: reading down and distinguishing Gilead

The majority held that in order to satisfy paragraph 4(2)(b), the '329 Patent was required to contain a claim that included the two medicinal ingredients found in TRIFEXIS® according to the three-part test set out in Abbott.2 The Court found that unlike the patent in Gilead, the '329 Patent met this threshold for the following reasons:

  1. Gilead is distinguishable. The majority interpreted the Gilead Court's conclusion to be based upon a construction that did not include rilpivirine (the third medicinal ingredient in COMPLERA®). It emphasised that, by contrast, Bédard J had correctly construed the relevant claims of the '329 Patent to include the combination of spinosad and milbemycin oxime based upon the definition of "oral formulation" in the description.
  2. Gilead did not require a perfect match. The majority held that "the question at the third step of the Abbott test is not whether the words milbemycin oxime appear in the claims of the '329 Patent, but whether the claims of the '329 Patent claim milbemycin oxime in the formulation set out in the patent". A perfect match is not required.

The majority concluded that as a result of the foregoing, the '329 Patent was eligible for listing and allowed the appeal.

The concurring reasons: Gilead was wrongly decided

In concurring reasons, Dawson JA agreed with the majority on all but one point: She could not distinguish the claims in Gilead from those of Lilly's '329 Patent. In her opinion, Gilead's patent claimed and would have been infringed by a formulation of the three medicinal ingredients in COMPLERA®. Thus, she regarded the issue in Gilead to have been whether the patent could be listed given that did not specifically name rilpivirine as a medicinal ingredient

Madam Justice Dawson stated that "if the patent claims the approved medicinal ingredient there will be a sufficient nexus between the patent and the subject of the notice of compliance to allow the patent to be listed". She held that this interpretation was consistent with the text of paragraphs 4(2)(a) and 4(2)(b), as well as the purpose of the Regulations: to regulate the early-working exception under the Patent Act.3 She concluded that Gilead was wrongly decided.

Background on recent developments regarding product-listing eligibility

The patent-listing eligibility provisions of the Regulations were amended on June 19, 2015 in order to clarify the application of section 4, particularly as it relates to fixed-dose combination products.4 In the associated Regulatory Impact Analysis Statement, the government explained that aspects of the judgments in Gilead and a more recent case, ViiV, were inconsistent with the policy intent of section 4 because they excluded patents that ought to be eligible for listing.5 The resulting changes are explained in two "Pharma in brief" publications, referenced below. The Lilly case was decided on the law as it stood prior to the June 19 amendments. The Court of Appeal did not refer to either of the amendments or its decision in ViiV.

Link to decisions:

The decisions with respect to the TRIFEXIS® matter can be found by following these links:

Federal Court of Appeal: Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166

Federal Court: Eli Lilly Canada Inc v Canada (Attorney General), 2014 FC 152

In addition, the Pharma in brief publications on recent activity concerning patent-listing eligibility can be found at the following links:

Pharma in brief - Official Publication of Amended PM(NOC) Regulations Now Available — Patents claiming single medicinal ingredients are eligible for listing on the Patent Register for combination drugs

Pharma in brief - Amended PM(NOC) Regulations now in force — Patents claiming single medicinal ingredients are eligible for listing on the Patent Register for combination drugs

Footnotes

1. Gilead Sciences Canada Inc v Canada (Minister of Health), 2012 FCA 254, leave to appeal to SCC ref'd 2013 CanLII 14304 [Gilead].

2. Abbott Laboratories Limited v Canada (Attorney General), 2008 FC 700, aff'd 2008 FCA 354 [Abbott].

3. RSC 1985, c P-4.

4. Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2015-169.

5. ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 [ViiV].

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
Borden Ladner Gervais LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Borden Ladner Gervais LLP
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