UK: Biotechnology Newsletter

Last Updated: 6 December 2007
Article by Julie Fyles

Second Medical Use

Claims In Europe

Second medical use claims including a novel treatment regime are attracting controversy in Europe both in terms of whether they should be granted and whether courts should enforce them. The following case sheds a little more light on the issue.

The Technical Board of Appeal (TBA) of the European Patent Office (EPO), in Decision T 1020/03, held that second medical use claims whose novelty lies in a treatment regime should be patentable.

This particular case concerned the finding that a patient with a chronic disease, such as chronic renal failure, could be treated more effectively with insulin-like growth factor-1 (IGF-1) if exposed to cycles of treatment, as opposed to continuous treatment.

The claims were drafted as second medical use claims but included a cyclical treatment regime. They were rejected by the Examining Division which considered "The prescribing and modification of drug regimes … appear to be part of the typical activities and duties of the Doctor in attendance in exercising his professional skills in curing, preventing or alleviating the symptoms of suffering and illness." They were therefore rejected as being non-industrial medical activities falling within Article 52(4) EPC.

The applicant argued that the treatment regime was novel and that it provided for long-term therapy with reduced side effects which, in turn, brought about a potential increase in the market for IGF-1.

The TBA held that the claims were allowable because:

  1. Given the claims were in a Swiss format, the patent proprietor would only have a remedy against the maker or dealer of the composition that was to be used in the relevant treatment; the use of the composition for therapies was not covered by this claim format.
  2. The Enlarged Board of Appeal Decision G5/83, which established second medical use claims, said that "if the therapeutic application was novel and inventive, then a patentee could obtain protection for the use of a composition for making a medicament for use in this therapy even though the only novel feature was the therapy which itself was a non-commercial and non-industrial medical activity".
  3. The TBA considered it appropriate to "choose a broad interpretation (of the relevant exclusion) which does not require any restriction of the area where novelty can be looked for".
  4. "The fundamental considerations moving the Board, namely that any invention in the pharmaceutical field is in essence a new method of using a composition in a therapeutic treatment, and that any ingenious chemistry is merely incidental to this use. Use of any composition at a low enough level is likely to have negligible effect for good or ill, whereas use at too high a level may lead to severe ill effects, or possibly a fatality. An invention lies in finding the use (including both level of dose and the form of application) where at least some types of patient will receive a net benefit from application of the composition."
  5. "The marketing of pharma-ceuticals is tightly controlled within the EPC Contracting States by the relevant control authorities, including for the EU, the European Medicines Agency. This means that for most pharmaceuticals it can be established for what therapeutic treatment they are marketed. This makes it practicable to grant patent rights with Swiss form claims which are enforceable against identifiable suppliers of an old substance for a specific new therapeutic use, but not against the persons ultimately responsible for this use, the physicians. The Board does not see Swiss form claims, even when they refer to steps to be taken by a physician, as interfering with the liberty of the physician to do the best for the patient, but only as restricting the purpose for which suppliers may act freely."

The case also included a discussion of national decisions within EPC Contracting States and noted a divergence of view. In the UK, the House of Lords has yet to express its views on second medical use claims that are drafted in the form of a particular treatment regime. This decision will therefore be reported in a future newsletter.

We conclude this article with Judge Jacobs’ (as he was then) comments on second medical use claims whose novelty is defined by a treatment regime. "Patents are provided to encourage research. If new and non-obvious improved methods of administration of known drugs for known diseases are not patentable in principle – even with a Swiss form claim, then there will be less of a research incentive to find such methods."

Snippet: On 1 July 2007 Alison Brimelow CBE, previous Comptroller of the UK Patent Office, took over as President of the European Patent Office. During her time at the UK Patent Office, Alison made significant improvement in terms of organisation and efficiency and was both admired and respected by her colleagues. We wish her well in her new post.

Fast Track Europe

The European Patent Office is currently piloting a fast track scheme whereby European patent applications claiming priority from searched UK patents undergo an expedited procedure. Germany, Denmark and Austria are also participating in the pilot project with a view to determining whether better use of national searches can expedite procedures for at least some applicants at the European Patent Office.

Snippet: The Norwegian Parliament will ratify and accede to the European Patent Convention. It will become a member of the EPO at the beginning of next year.

Snippet: With effect from 1 July 2007 Sweden has notified the International Bureau that the time limit for entering the National Phase before it as a designated or elected office is 31 months. This means that the only States that do not yet apply the 30 month time limit for entering the National Phase under Chapter I, as fixed in PCT Article 22, are Switzerland, Luxembourg, Tanzania and Uganda.

Referrals To The Enlarged Board Of Appeal

There have been a number of referrals to the Enlarged Board of Appeal which concern the interpretation of the European Patent Convention as it applies to our field.

The first one concerns Article 53(b) which says:

European Patents shall not be granted in respect of:

(b) plant or animal varieties are essentially biological processes for the production of plants or animals; this provision does not apply to microbial processes or the products thereof.

The referring Board found that the correct interpretation of Article 53(b) has yet to be determined and posed the following two questions for the Enlarged Board to consider.

  1. Does a non microbial process for the production of plants which contains the steps of crossing and selecting plants escape the exclusion of Article 53(b) EPC merely because it contains, as a further step or as part of any of the steps of crossing and selection, an additional feature of a technical nature?
  2. If question 1 is answered in the negative, what other relevant criteria for distinguishing non-microbiological plant production processes, excluded from patent protection under Article 53(b) EPC, from non-excluded ones? In particular, is it relevant where the essence of the claimed invention lies and/or whether the additional feature of a technical nature contributes something to the claimed invention beyond a trivial level?

The case that led to this referral concerned a method of producing broccoli having elevated levels of glucosinolates, a class of compounds with anti-cancer potential.

The second case referred the following points of law to the Enlarged Board of Appeal.

  1. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04), which comprises or encompasses a step consisting in a physical intervention practised on the human or animal body (in the present case, an injection of a contrast agent into the heart), to be excluded from patent protection as a "method for treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if such step does not per se aim at maintaining life and health?
  2. If the answer to question 1 is in the affirmative, could the exclusion from patent protection be avoided by amending the wording of the claim so as to omit the step at issue, or disclaim it, or let the claim encompass it without being limited to it?
  3. Is a claimed imaging method for a diagnostic purpose (examination phase within the meaning given in G 1/04) to be considered as being a constitutive step of a "treatment of the human or animal body by surgery" pursuant to Article 52(4) EPC if the data obtained by the method immediately allows a surgeon to decide on the course of action to be taken during a surgical intervention?

Referrals such as these are clearly welcomed by members of our profession, because the resultant decisions (to be reported in due course) enable us to advise clients with greater accuracy.

Snippet: With effect from 2 April 2007 the UK Patent Office changed its name to the UK Intellectual Property Office.

The Thorny Issue Of Added Matter

A recent case in the UK High Court, European Central Bank v. Document Security Systems Inc reminds us about the dangers in the UK (and EP) of amending patent claims to refer to integers that are not explicitly disclosed in the original application and thus invalidating the patent document.

The judge for this case, Kitchen J, stressed that "the (added matter) test is merely whether the alleged added matter goes beyond what was disclosed in the application. The fact that the alleged matter would be obvious based on what was disclosed is of no help to a patentee if there was no actual disclosure".

Helpfully, the Judge set out six guidance points on making an added matter analysis.

  1. The Court must construe both the original application and amended specification to determine what they disclose. For this purpose, the claims form part of the disclosure.
  2. The exercise must be carried out through the eyes of the skilled addressee, who will approach the documents with the benefit of the common general knowledge.
  3. The two disclosures must be compared to see if any relevant added matter has been added. This comparison is strict, and matter will be considered "added" if it was not clearly and unambiguously disclosed in the filed application.
  4. Both the express and implicit disclosures are relevant.
  5. Only subject matter relevant to the invention is a problem. The provision is aimed at preventing the applicant from obtaining an unwarranted advantage by extending the application as originally filed, and also to protect third parties who rely on original disclosure to judge the scope of the granted monopoly. If the feature merely excludes protection for part of the subject matter of the claimed invention as covered by the application as filed, then these principles are not offended against.
  6. Hindsight must be avoided. Therefore, it is appropriate to view the disclosure through the eyes of a skilled person who has not seen the amended disclosure and does not know what he is looking for.

Unity Of Invention

We are reporting the following TBA case on unity of invention because quite often the European Patent Office, in its capacity as International Searching Authority, raises a unity issue against a set of claims and invites an applicant to pay additional search fees.

Where the unity issue seems ill-founded, it is possible to pay additional search fees under protest and so have the issue of unity re-examined. However, there is a feeling that overturning the initial ruling is an uphill struggle. The following case demonstrates some success.

The claims at issue are second medical use claims (a popular format in this Newsletter). Claims 1-48 concerned

Use of a secretagogue compound or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the stimulation of appetite, food intake and/or weight gain in an individual suffering from liver failure.

Claims 49-67 concerned

Use of a secretagogue compound or a pharmaceutically acceptable salt thereof for the preparation of a medicament for the stimulation of appetite, food intake and/or weight gain in an individual suffering from renal failure.

On first inspection the unity issue seems justified.

However, the ISA raised the unity issue on the basis that the common concept pertaining to the two claims, i.e. use of a secretagogue for the stimulation of appetite, food intake and/or weight gain in an individual suffering from liver failure or renal failure, was known having regard to D1. Since the common concept was not novel, there was a lack of unity.

Under review, D1 was said to describe secretagogue compounds and give a detailed list of their use including treating renal failure resulting in growth retardation; reducing cachexia and protein loss due to chronic illness such as cancer or AIDS.

However, it was decided that in order to assess the novelty of the claimed subject matter, it is not permissible to combine separate uses belonging to different embodiments. In particular, the described use of the secretagogue compounds, in D1, for reducing cachexia due to chronic illnesses such as cancer or AIDS may not be combined with the use of secretagogue compounds in patients with renal failure in order to arrive at the conclusion that reducing cachexia in patients with renal failure is also disclosed, thus this combination is not directly and unambiguously derivable from the documents.

Accordingly, the Board of Appeal considered that the claimed subject matter was novel over D1 and that the issue of inventive step would require a detailed discussion with the applicant. In the circumstances, the requirement of unity was said to be met and both the additional search fee and the protest fee was refunded.

This case therefore illustrates that it is possible to overturn decisions concerning unity of invention and that, as always, the devil is in the detail.

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.

In association with
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
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.