European Union: EPO Practice - Patenting Human Embryonic Stem Cells in Europe

The patentability of biotechnological inventions in the European Union is governed by European Directive 98/44/EC (the "Biotech Directive").  One effect of the Biotech Directive is to prohibit patents on the use of human embryos for commercial or industrial purposes. 

This issue commonly arises in the field of human embryonic stem cells.  Embryonic stem cells are derived from early stage embryos, and the original methods for obtaining such cells involved destroying the embryo.  The European Patent Office (EPO) interprets the Biotech Directive as meaning that a patent may not be granted to any product or method that requires the destruction of a human embryo.  This has been further clarified by recent decisions of the EPO and the Court of Justice of the European Union (CJEU), which have considered what is meant by the term "embryo" in this context, and how this prohibition should be applied in the context of downstream products and processes. 

Definition of an "Embryo"

In a 2011 decision (Case C-34/10, Oliver Brüstle v. Greenpeace eV), the CJEU held that the term "embryo" should be interpreted broadly to cover all stages of human development after fertilization of a human egg, and also to cover all similar cells that are "capable of commencing the process of development of a human being."  This meant that a wide variety of cell types fell within the exclusion from patentability.

However, in December 2014, the CJEU was asked to consider this issue again, this time in the particular context of parthenogenetically activated human oocytes, i.e., human egg cells that had been chemically activated but that had not actually been fertilized.

In their 2011 decision, the CJEU specifically stated that this type of activated oocyte should be included in the definition of an embryo because these cells are "capable of starting" the process of development into a human being.

However, in their 2014 decision (Case C-364/13, Int'l Stem Cell Corp. v. Comptroller General of Patents, Designs and Trade Marks), the CJEU reviewed new technical information and came to a different conclusion.  They held that a human embryo should only cover cells that have the inherent capacity to develop into a human being.  The term "embryo" therefore does not cover all cells that are capable of starting to develop into a human being, only those that have the capacity to fully develop into a human being. 

Based on the evidence presented to the court in this case, it seems that parthenogenetically activated human oocytes will now be patentable in Europe.  It is also possible that some other cell types, which would have been excluded from patentability under the CJEU's 2011 decision, may now be patentable if it can be shown that they are not capable of fully developing into a human being.

Effect on Downstream Products and Processes

Prior to the CJEU's 2011 decision, the EPO had taken the view that the exclusion provided by the Biotech Directive would not apply if it was possible to obtain suitable human embryonic stem cells from a commercially available cell line.  For example, if human embryonic stem cells could be purchased from such a cell line at the priority/filing date of the patent, then any downstream methods, uses, or products derived from them could be patented.

However, in its 2011 decision (Case C-34/10, Oliver Brüstle v. Greenpeace eV), the CJEU also concluded that the "use of a human embryo" in the Biotech Directive does not have to be part of the invention that is claimed.  If a human embryo was destroyed at any earlier stage, even if that destruction occurred long before the implementation of the invention, then the invention cannot be patented.  This means that, for example, new uses of a commercially available human embryonic stem cell line may not be patentable, if that cell line was originally produced by a method that involved destroying a human embryo.  The effects of the Biotech Directive therefore apply not only to human embryos and their direct uses, but also to all downstream methods and products that derive from them.

This approach is now followed by the EPO.  For example, in decision T1441/13, issued in September 2014, the EPO's Board of Appeal refused an application directed to a method of producing differentiated cells from primate pluripotent stem cells, such as human embryonic stem cells.  The claimed method did not indicate the source of the cells, but the Board of Appeal concluded that the known and practiced method of obtaining human embryonic stem cells at the filing date of the patent application required the destruction of human embryos.

The Board also concluded that the first public disclosure of a method by which human embryonic stem cells could be obtained without destroying a human embryo was published by Chung et al. ("Chung") in January 2008.  In practice, therefore, claims relating to human embryonic stem cells may be allowed by the EPO if they have a priority/filing date of January 2008 or later, as they can rely on Chung's nondestructive methods of obtaining cells from human embryos.  However, if the patent application relates to particular human embryonic stem cells that could not be obtained using Chung's method, such as particular cell lines that are known to have been produced by a destructive method, such an argument is unlikely to succeed. 

If European patent claims encompass both destructive and nondestructive methods, it may be necessary to disclaim any products, methods, or uses that required the destruction of a human embryo.  The Board also made it clear that such a disclaimer can only be used in cases where nondestructive methods were available at the filing date.  In cases filed prior to January 2008, such a disclaimer cannot be used because suitable nondestructive methods were not available.


This is an area of law that is likely to keep developing as companies try to test the boundaries of the exclusion and to identify what inventions they can protect using the patent system in Europe. 

For example, the EPO's current use of a January 2008 cut-off date is based on the assumption that no earlier methods were available for obtaining human embryonic stem cells without destroying an embryo.  However, as the case law develops, earlier publications may become relevant.  For example, we must wait to see whether interested parties can establish a date earlier than January 2008 for the availability of stem cells produced from parthenogenetically activated oocytes.

This means is that there is likely to be uncertainty for companies working in this area for some time to come.

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.

Events from this Firm
27 Nov 2017, Seminar, London, UK

Finnegan partner Anthony Tridico will present “U.S. Patent Case Law Update” at the Chartered Institute of Patent Attorneys’ annual Patent Case Law Review.

28 Nov 2017, Seminar, Milan, Italy

Finnegan partner John Paul will present “Internet of Things: Patent Liability, Enforcement and Licensing” and will join the Mock WIPO Mediation at International Technology Transfer—Licensing and ADR, co-hosted by Licensing Executives Society and World Intellectual Property Organization.

29 Nov 2017, Seminar, Tel Aviv, Israel

Finnegan is a platinum sponsor IVC Research Center’s start-up forum, “The Most Promising Start Ups for 2017 – A Synergy of Big Data, Artificial Intelligence, Machine Vision and IoT.”

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.


From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .


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.