Canada: Patentees Score A Victory In The Supreme Court Of Canada: Validity Of Selection Patents Upheld

Last Updated: December 3 2008
Article by Alfred A. Macchione, Steven Mason, Anita Nador and Steven Tanner

Most Read Contributor in Canada, September 2018

Overview

On Thursday, November 6, 2008, the Supreme Court of Canada released its much-anticipated decision in Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2008 SCC 61 (Sanofi). In this landmark decision, the Supreme Court gives considerable strength to pharmaceutical patents by rejecting Apotex's generalized attack on selection patents as "evergreening" and holding that selection patents do not differ in nature from any other type of patent. The case is also significant because it adds important clarification to the test for anticipation and brings the law with respect to obviousness into closer alignment with that of the United States and United Kingdom.

Background

The Sanofi case commenced as an application to the Federal Court of Canada brought pursuant to the Patented Medicines (Notice of Compliance) Regulations, in respect of the blockbuster drug PLAVIX (clopidogrel bisulfate). Sanofi is the holder of Canadian Patent No. 1,194,875. The '875 Patent contains "genus" claims that encompass about 250,000 compounds, including the racemate of clopidogrel. A racemate is a substance containing equal amounts of two structurally different compounds called optical isomers. Although isomers share the same molecular formula, they can have very different properties. Significantly, the '875 Patent does not distinguish between the isomeric forms of clopidogrel — both are encompassed within the claims.

Sanofi subsequently discovered that a particular isomer of clopidogrel is less toxic and better tolerated than its other isomer. It is the beneficial isomer that was claimed in Canadian Patent No. 1,336,777.

Apotex challenged the validity of the '777 Patent on the grounds of anticipation, obviousness, and double patenting. Sanofi was successful at trial and on appeal. The Supreme Court also found in favour of Sanofi and dismissed Apotex's appeal. As a result, the Minister of Health is prohibited from issuing regulatory approval to Apotex in respect of its clopidogrel product prior to the expiry of the '777 Patent.

The Decision

The Sanofi decision involves a so-called "old Act" patent. While the statutory law cited by the Court therefore comes from the Patent Act as it read pre-October 1989, the decision will undoubtedly have broad applicability even to so-called "new Act" patents.

Anticipation

Justice Rothstein (writing for the Court) relies heavily upon the House of Lords' decision in Synthon BV v. Smithkline Beecham plc, [2005] UKHL 59, which articulates the two-step approach to the anticipation inquiry: "prior disclosure" and "enablement." This approach, which had already been applied in some cases in the lower courts, is now solidified in Canadian law.

For a claim of a selection patent to be anticipated, the first requirement is that the prior patent must disclose subject matter that, if performed, would necessarily result in the infringement of the subsequent patent. There is no room for trial and error or experimentation by the skilled person. If no such disclosure is apparent from reading the document, there is no anticipation. In the case of the '875 Patent, since it did not disclose the special advantages of the isomer claimed in the '777 Patent, the disclosure requirement was not met. It was not sufficient that the compound claimed in the selection patent was also encompassed within a claim in the '875 Patent.

If prior disclosure is found, the second requirement to prove anticipation is "enablement," which means that the skilled person would have been able to perform or work the invention of the new/selection patent as disclosed in the prior/genus patent in light of common general knowledge without "undue burden." For the enablement inquiry, the person skilled in the art may engage in some "routine" trial and error experiments in order to get the invention to work, but "prolonged and arduous trial and error experiments" are not permitted. The Court noted that the evidence in this case demonstrated that the identification of a particular isomer of clopidogrel and its advantageous properties required extensive investigation over a period of months, which suggested that such investigation would have constituted an undue burden for the skilled person (although a determination on this issue was not made, given the Court's holding that the first part of the test was not met).

Obviousness

The key issue in Sanofi was whether the law of obviousness in Canada should be brought more in line with jurisprudence in the United States and United Kingdom, both of which accept that the "obvious to try" test can be relevant in an obviousness inquiry (most recently in KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727). The Court agreed it was time to incorporate an "obvious to try" test into Canadian law. However, it said that such a test was only one factor to consider and, importantly, that it "will work only where it is very plain or ... more or less self-evident that what is being tested ought to work." The mere possibility that "something might turn up" in the experiment is not sufficient to meet the obvious to try test.

Justice Rothstein sets out a four-step approach for assessing an allegation of obviousness:

  1. (a) Identify the notional "person skilled in the art."
    (b) Identify the relevant common general knowledge of that person.
  2. Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it.
  3. Identify what, if any, differences exist between the matter cited as forming part of the "state of the art" and the inventive concept of the claim, or the claim as construed.
  4. Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps that would have been obvious to the person skilled in the art or do they require any degree of invention?

It is in the fourth step that the issue of obvious to try will arise (although it is only a factor to consider). In this respect, Justice Rothstein observed that the obvious to try test may only be appropriate in cases where advances are won by experimentation. In such cases, he held that the following factors should be considered:

  1. Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art?
  2. What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials would not be considered routine? On this issue, the Court suggested that evidence about the actual course of conduct in reaching the invention might be useful (was it relatively straightforward or costly and time-consuming?).
  3. Is there a motive provided in the prior art to find the solution the patent addresses?

The evidence in Sanofi was that there were just five methods that might be used to isolate the particular isomer of clopidogrel that was the subject of the '777 Patent, that all steps to test the isomers used to identify their benefits were known, and that there was a motivation to find compounds with the benefits disclosed in the '777 Patent. Importantly, Justice Rothstein held that just because there are known methods of separating the isomers, that "does not mean that a person skilled in the art would necessarily apply them." Justice Rothstein also held that nothing in the earlier patent or common general knowledge provided a specific motivation for the skilled person to pursue the invention of the selection patent. Although it was known that the properties of a racemate and its isomers may be different, it was not known what they would be or what these differences were. The possibility of finding the invention is not enough. The specific invention must be "self-evident" before the attempt is made. Justice Rothstein also observed that it took over a year for Sanofi to find the invention after spending millions of dollars developing the racemate without even exploring the possibility that a particular isomer would be superior. In light of these factors, the Court found that the invention claimed in the selection patent was not self-evident or obvious from the prior art and common general knowledge.

Double Patenting

Justice Rothstein reaffirmed the approach articulated by Justice Binnie in Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067 to the prohibition against double patenting, which will invalidate a second patent covering the same invention as the first. There are two types of double patenting: (1) coterminous double patenting, and (2) obviousness-type double patenting.

The justification for imposing the prohibition against double patenting is to prevent evergreening. However, Justice Rothstein stated that "a generalized concern about evergreening is not a justification for an attack on the doctrine of selection patents."

Justice Rothstein held that the invention claimed in the two patents was not the same, even though the same clopidogrel isomer claimed in the selection patent was also encompassed within the claims of the '875 Patent. The breadth of the invention claimed in the previous patent was larger than the breadth of the invention claimed in the selection patent, and the particular isomer claimed in the selection patent had beneficial and non-obvious properties over those compounds claimed in the prior patent.

Conclusion

This decision is an important victory for patentees in Canada. According to the evidence in the case, about eight out of every 10 pharmaceuticals currently on the market involve selection patents. It is important that financial incentives are available to drug researchers to continue searching for new and better drugs, and this decision decisively confirms that protection for such innovation is available in Canada. In dismissing Apotex's appeal, the Court clearly held that selection patents in Canada are valid in principle.

Moreover, the Court articulated a clear test for anticipation and obviousness that should present serious obstacles for validity challenges in view of how those tests were considered and applied to the facts of this case.

Finally, this decision demonstrates the Court's willingness to revamp Canadian patent law by taking into account foreign jurisprudence to a degree never before witnessed in other Supreme Court decisions involving patents. Notably, the "worth a try" test, previously discredited by lower courts as a consideration in the obviousness inquiry, was incorporated into Canadian law in part based on the confluence of the law in the United States and the United Kingdom. That approach points towards potential further harmonization of Canadian law as further issues of patent law come before the Court.

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
 
In association with
Related Topics
 
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