Canada: Personalized Medicine: Patent issues In Canada And Europe

"Personalized medicine," in its broadest aspects, is essentially the tailoring of treatments to individual characteristics, needs and preferences. More commonly, the term is used to refer to the tailoring of treatments to an individual based on his or her personal genetic makeup and prior treatment history.

The development of personalized medicine approaches involves much time, effort and expense, and there is a strong interest in protecting innovations in this area in a meaningful way. In Europe and Canada, methods of medical treatment are not considered to be patentable subject-matter, with both jurisdictions taking the approach that patents ought not to interfere with the ability of physicians to exercise their skill and judgment. Protection for therapeutic methods can nevertheless still be obtained in both jurisdictions by drafting claims in an acceptable "use" format.

Treatment-related personalized medicine claims are by definition "second medical use" claims, in that they relate to the use of a known therapeutic. An added complication is that such claims typically also relate to the use of that known therapeutic to treat the same disease as previously treated, differing only in one or more or the population being treated, the route of administration, the dosage amount and/or the dosage regimen.

In the following, we summarise briefly the approaches being taken by the courts and the patent offices in Europe and Canada with respect to such claims.


In Europe, methods of medical treatment are specifically excluded from patentability by statute (Article 53(c) EPC, which also allows for use-limited product claims).1 Article 54(5) EPC, introduced with the EPC 2000 revisions, allows for claims to second medical uses.2

Prior to introduction of Article 54(5) EPC, the patentability of second medical uses had been established in the Enlarged Board of Appeal Decision G5/83. Several Technical Board of Appeal decisions considered the issue of what constituted a "specified new and inventive therapeutic application" in accordance with G5/83, particularly with respect to treatment of sub-populations. In one of the earliest and frequently referenced decisions, T19/86, which related to the claimed use of a known therapeutic for prophylactic treatment of the same disease in an immunologically different population of animals, the board concluded that G5/83 should be broadly construed. In particular, the board indicated that the question of whether a new therapeutic use is in accordance with G5/83 should be answered not only on the basis of the ailment to be treated, but also on the basis of the subject or patient to be treated.

In T19/86, the prior art and claimed populations were distinct (sero-negative versus sero-positive piglets), however, in many instances a claimed sub-population may overlap to some extent with the previously treated population. The issue of overlapping populations was considered in T0233/96, where the board interpreted preceding decisions as indicating that in order for a use of a known treatment in a patient sub-group to be novel, the sub-group could not overlap with the group previously treated. In addition, the sub-group must be distinguishable from the prior population by its physiological or pathological status, and selected based on a functional relationship between this physiological or pathological status and the therapeutic effect obtained (rather than being an arbitrary selection).

The board in T1399/04 also considered overlapping populations of patients, but in this case found that despite an overlap in treated populations, the claimed use was novel because the recited sub-group was defined by a previously undisclosed pathological and physiological status, and its selection was not arbitrary. In particular, the board focused on the demonstrated functional relationship between the claimed sub-group and the improved effect of the claimed treatment. In a more recent decision, T0734/12, the board likewise found claims directed to a known treatment using a particular dosage regimen in a specified sub-population of patients to be novel, even though the dosage regimen was known for the same treatment of a different but overlapping population. The board held that the claimed sub-population had a different physiological and pathological status to the prior population, thus rendering the claimed use novel. The use was, however, found to lack an inventive step, primarily because the patent did not include any data demonstrating an improvement over the prior art treatment.

In contrast to the fairly expansive approach taken in the above decisions, however, the approach being adopted by the European Patent Office (EPO) to claims relating to treatment of sub-populations appears to be more limited. The EPO has expressed the opinion that inventions in the area of pharmacogenomics such as those involving a new patient group defined by a biomarker, often lack novelty.3 Specifically, the EPO has indicated that in such cases, it assumes at least one patient with the biomarker inevitably has been previously treated, even if the art does not explicitly say so, and the claim is therefore anticipated. Thus, the EPO can be expected to raise novelty objections against a claim directed to use of a known treatment in a sub-population of patients with a specified biomarker, if it can be established that the biomarker is present in a significant proportion of patients.

There is some indication, however, that the EPO may consider a claim drafted as a diagnostic-style "identify and treat" claim reciting an active step of determining whether or not a patient has a particular biomarker and then treating the patient accordingly, to be novel. Novelty in this case resides in the step of determining whether the patient has the biomarker, and will be dependent on whether a link has been established between the presence/absence of the biomarker and an improvement in the treatment.

The inclusion of supporting data in an application is thus emerging as a key factor in obtaining personalized medicine claims in Europe. Such data will be essential to establish that selection of any claimed sub-population/dosage regimen/route of administration is not arbitrary, but based on a functional relationship between the claimed feature and an improved effect of the claimed treatment.


In contrast to Europe, exclusion of methods of medical treatment and patentability of second medical uses in Canada are both based in case law.4,5  Also in contrast to Europe, where claims that are drafted in the correct "use" format are assumed to be directed to patentable subject-matter,6 care needs to be given to the exact wording used in medical use claims in Canada to ensure that an otherwise correctly formatted claim cannot be equated to a method of medical treatment. For example, inclusion of a medical or surgical step, or a step or aspect that may be construed as requiring the skill and judgment of a physician,7 will result in a medical use claim being deemed non-statutory. Many of the challenges encountered when prosecuting and defending personalized medicine claims in Canada stem from the fact the claims are being construed as relating to non-statutory subject matter.

Of note in this regard are three practice notices recently published by the Canadian Intellectual Property Office (CIPO) outlining revisions to the CIPO's practice for determining whether claimed subject matter is statutory.8 The most relevant of these practice notices to personalized medicine claims is PN2013-04 "Examination Practice Respecting Medical Uses," which expands on the guidance provided in the Manual of Patent Office Practice (section 17.02.03). The notice is primarily focused on claims that recite dosage regimens or dosage ranges, but also discusses other aspects of personalized medicine, including treatment of a sub-population of patients.

PN2013-04 follows a purposive construction approach when analyzing the claims to determine whether the claimed subject-matter is statutory, which requires that the "essential elements" of the claim be identified.9 If an essential element is considered to be a medical or surgical step, or to require a physician's skill or judgement, then the claim is considered to be directed to a method of medical treatment.10

In particular, the CIPO considers that if, purposively construed, the claim relates to "what" to use to treat a patient (for example, a composition, formulation or dosage form), then the claim is generally acceptable. However, if the claim relates to "how" to treat a patient (for example, a route of administration or a specific dosage schedule), then the CIPO considers that the claimed use is non-statutory. In adopting this approach, the CIPO references the Supreme Court decision of Apotex.11 Interestingly, the use claim considered in Apotex does not refer to "how" or "when" the drug is administered, but rather defines a dosage form, which was determined to be statutory.12 An alternate interpretation of Apotex would be that if no professional skill is required to determine the "how" or "when," in a manner analogous to providing a dosage form, then the claim should be acceptable. PN2013-04 appears to simplify the determination of the requirements for patentability by suggesting that any claim directed to providing an invention based on the "how" (or "when") is not statutory.

PN2013-04 further states that essential elements "that narrow treatment to a patient sub-population (rather than bring treatment to a new population) or administration site," are also considered to limit a physician's professional skill or judgment, and thus are non-statutory. Example 7.1 of PN2013-0413 is provided to illustrate this scenario and provides a sample claim relating to treatment of a "sub-population" of patients who respond more efficiently to a known treatment ("compound X") due to their genetic makeup. The CIPO indicates that such a use would be considered non-statutory as it restricts the choices of a physician on how to use compound X. Accordingly, claims directed to sub-populations are considered non-statutory under current Canadian practice, even though this determination is not based on any Canadian jurisprudence.

Interestingly, PN2013-04 also indicates that the use in Example 7.1 would not be considered to be a selection because " a selection, all of the range claimed must be novel," whereas some of the patients in the example would previously have been treated using the same drug without knowledge of their genetic makeup. This interpretation by CIPO of the test of a proper selection appears to be controversial and inconsistent with the conclusion arrived at by the Supreme Court of Canada in Sanofi.14

The features established in Sanofi as defining a valid selection include an advantage (or disadvantage) shared by the selected group; the whole of the group possesses the advantage, and the selection is in respect of a quality or character peculiar to the group. While Sanofi also established that the compounds of the selection cannot have been made before, it is of interest that in Sanofi the selected compound was a stereoisomer with beneficial properties when compared to the known racemic mixture of D- and L-isomers.  The beneficial isomer had therefore been previously administered to a patient as part of the racemic mixture, however, the court still determined that this selected isomer was not anticipated or obvious and was statutory. 

Nonetheless, CIPO's current practice, like the EPO's, is to reject any claims directed to the use of a known therapeutic to treat the same disease in a specified sub-population, such as patients with a specified biomarker. In Europe, these objections will be raised on the basis of lack of novelty, whereas in Canada, the objection will be that the claimed subject-matter is non-statutory. Both positions, however, appear to be at odds with the respective case law.

In Canada also, re-drafting such claims as "identify and treat" claims, which the EPO have indicated may be acceptable, is unlikely to be a viable option, as inclusion of a treatment step would result in the claim being construed as being directed to a non-statutory method of medical treatment. An alternative would be to amend the claim into a pure diagnostic claim. Another option may be to include a diagnostic step in a standard use claim in order to further define the patient being treated, for example, by specifying that the patient has been identified as suitable for treatment by screening the patient for a specific gene mutation.


This overview highlights some of the challenges in obtaining protection for personalized medicine inventions in Europe and Canada. While each jurisdiction is developing its own unique approach as to how to personalized medicine innovations should be protected, one commonality is that respective approaches currently being adopted by the patent offices are not necessarily in line with the relevant case law. Given that innovator companies are continuing to invest large amounts of capital into the personalized medicine space and to file patent applications for their innovations, it appears inevitable that the current patent office approaches will be challenged. It is to be hoped that more consistent case law and patent office practice will emerge as a result, as it has in more traditional practice areas. In the interim, there appears to be sufficient leeway in the respective patent office practices for applicants to obtain meaningful protection for personalized medicine inventions with some forethought and a creative use of claim language.


1 Art. 53(c) EPC states: European patents shall not be granted in respect of: ... (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

2 Art. 54(5) EPC formalizes the principle previously set out in the Enlarged Board of Appeal (EBA) Decision G5/83. Art 54(5) is read in conjunction with Art. 53(c) (see footnote 1), and Art. 53(1), (2) and (3): 

54. (1) An invention shall be considered to be new if it does not form part of the state of the art.
(2) The state of the art shall be held to comprise everything made available to the public by means of a written or oral description, by use, or in any other way, before the date of filing of the European patent application.
(3) Additionally, the content of European patent applications as filed, the dates of filing of which are prior to the date referred to in paragraph 2 and which were published on or after that date, shall be considered as comprised in the state of the art.
(5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

3 See the summary of a meeting between the EPO and the biotech committee of the European Patent Institute (epi) published in the June 2012 issue of epi Information.

4 Tennessee Eastman Company v. Commissioner of Patents, [1974] S.C.R. 11.

5 Re Application for Patent of Wayne State University, 22 C.P.R. (3d) 407.

6 See, for example, Decision T1399/04, paragraph 21.

7 MOPOP 17.02.03 Medical and surgical methods.

8 PN2013-02 "Examination Practice Respecting Purposive Construction"; PN2013-04 "Examination Practice Respecting Medical Uses"; PN2013-03 "Computer-Related Inventions." The approach identified in these practice notices is influenced by the jurisprudence pertaining to Amazon's "one-click" patent application (CA 2,246,933). While the technology in the "one-click" application is computer-related, many of the principles established in this jurisprudence are broadly applicable across technologies (see Scott Foster and Konrad Sechley July 13, 2012, "Impacts of the decisions on medical use claims in Canada," in Life Science & Law Current Issues 2012/13).

9 The CIPO's approach to purposive construction is set out in practice notice PN2013-03 "Examination Practice Respecting Purposive Construction".

10 "Where an essential element only serves to instruct a medical professional 'how' to treat a patient, rather than 'what' to use to treat the patient, this will lead to the conclusion that the claimed use encompasses a method of medical treatment." PN2013-04, footnote omitted.

11 Apotex Inc. v. Wellcome Foundation Ltd. 2002, 21 CPR (4th) 499.

12 "The AZT patent does not seek to "fence in" an area of medical treatment. It seeks the exclusive right to provide AZT as a commercial offering. How and when, if at all, AZT is employed is left to the professional skill and judgment of the medical profession." Apotex Inc. at paragraph 50.

13 "Examples of purposive construction analysis of medical use claims for statutory subject-matter evaluation."

14 Apotex Inc. v. Sanofi-Synthelabo Canada Inc. et al. (2008)  69 C.P.R (4th) 251 (Sanofi) at [1].

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
In association with
Related Topics
Similar Articles
Relevancy Powered by MondaqAI
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