UK: Methods Of Treatment: Is There Any Protection Available In Europe?

Last Updated: 27 March 2003
Article by Colm Murphy

Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body are not patentable in Europe because they are not regarded as inventions which are susceptible of industrial application. This provision, which is set out in Article 52(4) of the European Patent Convention (EPC), is also embodied in the National laws of the member states of the EPC. The exclusion is included solely on the grounds of public policy to ensure that those who carry out such methods as part of their medical or veterinary duties are not inhibited by the existence of patents.

Pharmaceutical companies, however, carry out significant research to identify new therapeutic uses for known compounds. Because these compounds are already known, patent claims directed to the compounds per se are not available. In the United States developments of this type may be protected using method of treatment claims. So how then can protection be achieved for such new therapeutic applications within the legislative framework that is in place in Europe?

What is Patentable?

Firstly, Article 52(4) EPC, being an exclusionary clause, must be interpreted narrowly. It does not, of course, apply to those treatments that do not include a therapeutic element or constitute a surgical or diagnostic method. A single step in a claim that involves a therapeutic, surgical or diagnostic procedure will be sufficient to render the claim unpatentable. A considerable body of case law has developed in Europe that provides guidance on the types of methods that are considered to fall outside the exclusion.

Generally, therapy is interpreted broadly and embraces prophylactic methods as well as curative treatments, so trying to argue that a method does not result in therapy because it is merely preventative will not work. The question of whether a medical practitioner is required to carry out the method, while providing a useful indicator, is not sufficient in its own right to decide whether a particular method will be excluded. However, if a medical practitioner must carry out the procedure, it is a likely indication that a method of treatment is being performed.

Non-therapeutic treatments are patentable if the non-therapeutic effect is distinct and separate from any therapeutic effect. Thus, for example, cosmetic methods will be patentable if it can be shown that the cosmetic effect is not inextricably linked to any therapeutic effect that may also be occurring. If the effects are not separable, merely calling the method "a cosmetic method" will be insufficient to meet the requirements of Article 52(4).

A diagnostic method must, of course, be practiced on the human or animal body for it to be excluded, in which case any diagnostic method performed on cells in culture, or a sample obtained from a patient, should fall outside the exclusion. A surgical procedure is prohibited from patentability regardless of its intended purpose, therapeutic or otherwise.

Article 52(5) EPC explicitly provides that any substance or composition for use in a method of treatment may still be patentable. Therefore, the Article 52(4) exclusion is designed to control what a doctor administers to a patient as opposed to how he administers it. This concept of novelty is not available in any other technical field. For example, in the mechanical field, a claim worded as "apparatus for use in a field Y", will not be novel if the apparatus per se is known. The prescribed use is not considered limiting to the apparatus features. In the event that a known compound does not have any previously recognised use in any medical application, the Enlarged Board of Appeal of the European Patent Office (EPO) in the landmark decision of G5/931 ruled that such a new use can be claimed broadly as "composition X for use as a medicament", and no specific indication of the therapeutic use is required for the claim to be considered allowable.

Whereas broad protection seemed to be available for first medical indications of a known compound, the same was not the case for discoveries of new and further therapeutic applications of compounds that had already been used in a medicinal context. This is because Article 54(5) EPC provides that a substance or composition comprised in the state of the art for use in a method of treatment is patentable "provided that its use for any method referred to in Article 52(4) is not comprised in the state of the art". This, therefore, seemed to preclude from protection known medicinal compositions that were found to have another medical application, in that the wording of Article 54(5) EPC excludes from protection compounds which were used in any medical application. So how then could protection be obtained for these potentially valuable new medical applications of such known compounds?

"Use claims are not applicable because a claim worded as "use of compound X for treating disease Y" is interpreted by the EPO as a method claim, and methods of treatment claims are not allowable. The Enlarged Board of Appeal in G5/83 also decided, however, that a claim generally worded as "use of compound X in the manufacture of a medicament for treatment of disease Y" would be acceptable to cover the new medical applications on the basis that there was no intention in the EPC to exclude second (and further) medical indications generally from patent protection and the novelty of the claim resided in the new therapeutic use and not the method of manufacture. This wording has become the generally accepted format for "second medical use" or "Swiss-type" claims and they are routinely granted by the EPO.

Proposed Changes

At a recent diplomatic conference of the member states of the EPC2, it was proposed to amend Article 54(5) to dispense with the requirement for a Swiss-type claim, so that the article would read as follows: "...the provisions of this article shall not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in any method referred to in Article 53(c), provided that such use is not comprised in the state of the art". Thus, first medical use claims may still be phrased "compound X for use in therapy", whereas second or further medical uses can be claimed as "compound X for use in treating disease Y". However, no date has yet been set for when these revisions will come into effect.

In addition to the standard Swiss-type claim where protection is afforded to the new medical use of the known pharmaceutical compound, the EPO has also gone a stage further and ruled that a new mode of administration of a compound can of itself constitute a new medical use if it is a critical factor in a medical treatment. If the mode of administration was not previously disclosed a claim of this type will be allowable. In the Board of Appeal case, T51/93 (unpublished), the mode of administration claimed was subcutaneous as opposed to the traditional intramuscular method normally used. Even though the medical use itself was not novel, administration of the compound subcutaneously was considered sufficient to confer novelty to the claim.

The EPO has also allowed claims in the Swiss-type form where the only novel feature resided, not in the new therapeutic use, but in a new dosage regime for administering a compound that was already known for treating the same disease but offered, for example, less toxic side effects. Claims of this type must, however, be of questionable validity in light of some recent decisions of the national courts of the member states of the EPC, where issues of infringement are addressed.

Case Law

There have only been very few cases decided before the national courts concerning Swiss type claims, but a number of them do cast doubt on the validity of claims for which the only novel feature resides in the dosage regime or the mode of administration. The UK Court of Appeal, in the case of Bristol-Myers Squibb (BMS) v. Baker Norton Pharmaceuticals and NaPro Biotherapeutics, ruled that a claim that read: "use of taxol and sufficient medications to prevent severe anaphylactic reactions for manufacturing a medicament for simultaneous separate or sequential application for the administration of 135mg/m2 up to 175mg/m2 taxol over a period of about 3 hours or less as a means of treating cancer and simultaneously reducing neutropenia", was not a valid second medical use claim because the only novel feature was the dosage regime. The compound or medicament was already known for treating cancer and the dosage regime only represented further information about how to treat it. According to the Court there was, therefore, no new therapeutic use. The claim was considered to be a method of treatment and as such was declared invalid.

A similar conclusion was reached by the Dutch Court of Appeal in Bristol-Myers Squibb v Yew Tree of 25 June 1998. The courts in the Netherlands have also in the past refused to acknowledge the novelty of second medical use claims on the basis they are considered to be dressed up methods of treatment. In the latest decision from the Netherlands, General Hospital -v- Air Products,4 this interpretation was confirmed.


Although issues of validity have been addressed, what has been lacking to date is an indication of how the national courts will deal with the question of infringement of first and second medical use claims. In the first instance decision of BMS -v- Baker Norton and NaPro, the trial judge did not address the issue of infringement because the claims were considered invalid. The Court of Appeal did, however, consider infringement to assist in clarification of how the terms in the claims should be interpreted. They were of the view that clinical trials carried out on women with ovarian cancer in which taxol (175mg/m2) was administered intravenously every 21 days as a 3h infusion did amount to an infringement of the Swiss-type claim. However, not all cases of infringement will be as clear cut.

In the UK, a person infringes a patent for an invention if he commits any of the following acts in the UK during the term of the patent; (the relevant passages of Section 60 of the UK Patents Act only being provided):

  1. where the invention is a process, he uses or offers it for use in the UK when he knows or it is obvious to a reasonable person in the circumstances that its use there without the consent of the proprietor would be an infringement of the patent; and....
  2. if he supplies or offers to supply in the UK a person not entitled to work the invention, with any of the means, relating to an essential element of the invention, for putting the invention into effect....

Similar provisions apply in the other EPC countries. Where, for example, a third party sells only a composition, to prove infringement of a Swiss type claims it is necessary to establish whether the sale of the compound is for the purpose of treating the claimed illness, otherwise known as "contributory infringement". The primary infringers will be the medical practitioners who eventually administer the drug and who are exempt from infringement, unless they are using the compound in a manner which is not for private and non-commercial purposes. Thus, reference to the product literature accompanying any such composition will be required to establish contributory infringement, but this may not provide all of the answers if the drug is formulated in the same way to treat both the first and second medical conditions. Administration of the compound may have the effect of treating both the first and second medical indications. In the Air Products case in the Netherlands, the court did consider infringement. In this case, Air Products were selling a gas mixture but did not, itself carry out the steps of treating the illness covered by the patent. The court held that supplying the compound to put the invention into effect did not amount to contributory infringement because, first the gas mixture is readily available and second it was not shown that Air Products had incited its customers to carry out the method described in the patent.

One of the areas which is not at all clear is the question of Supplementary Protection Certificates (SPC) based on a Swiss-type claim in a granted European patent. EU Council Directive 1768/925 allows for the provision of SPCs for medicinal products and extends the period of protection for up to five years for these products, provided they are subject to regulatory approval before they can be placed on the market. The SPC is granted only for the active ingredient of the medicinal product that is the subject of the marketing authorisation permitting sale of the product on the market in the territory concerned and which product must be protected by a patent for that territory. However, an SPC cannot be granted for a product the active ingredient for which has, or is already, the subject of such a marketing authorisation. Thus, an SPC will not be allowed based on a second medical use claim if the active ingredient has already been the subject of a marketing authorisation. If a medicinal product has been sold for the treatment of the first medical indication, it will inevitably have been the subject of such an authorisation. To sell a product for any medicinal use, irrespective of whether it is for a first or second medical use, a marketing authorisation, including details of various clinical trials, is required. Thus, a product for treating a second or further medical use will be subjected to the same regulatory procedures but will not be eligible for an SPC if there exists a previous marketing authorisation for the same active ingredient.


In summary, useful protection for methods of treatment may be obtained in Europe by way of first and second medical use (Swiss) type claims, and such claims appear to be acceptable in principle to the courts of most of the member states of the EPC. The proposed revision of the EPC to specifically allow protection for such claims should clarify the position further. However, there are some issues to be addressed, such as their enforcement, which can only be decided in the national courts and which may well result in different outcomes between the member states.


1. OJ EPO 1985, 64

2 Diplomatic Conference for The Revision of The EPC, Munich 29 November 2000

3. UK Court of Appeal Decision, 23 May 2000

4 General Hospital -v- Air Products, District Court of The Hague, 16 February 2000

5. EEC Council Regulation No 1768/1992

© 2001. Boult Wade Tennant

This article appeared in the May 2001 issue of Nature Biotechnology magazine.

The content of this article does not constitute legal advice and should not be relied on in that way. Specific 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
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.