Netherlands: Stem Cell Patents In The EU: To Be Or Not To Be?

Last Updated: 20 October 2011
Article by John Allen, Paul van Dongen and Florence Verhoestraete


The patent of Oliver Brüstle that is at stake relates to purified neural precursor cells and to processes for their production from embryonic stem cells. Neural precursor cells may be used for the treatment of neural defects (like Parkinson's disease), which use is also claimed in the patent. According to the patent the embryonic stem cells from which the neural precursor cells are created are pluripotent, which means that they have the potential to develop into all kinds of cell types, but not into a complete human being. Only so-called totipotent cells are capable of developing into a human being.

Greenpeace is of the opinion that the subject matter of Brüstle's patent is not patentable because it would contravene public order and morality. Greenpeace argues that for the application of the invention it is necessary to use pluripotent embryonic stem cells, and that such stem cells can only be obtained by destroying an human embryo (although this latter step is not described or claimed in the patent). Article 6(2)(c) of the Biotech Directive (98/44/EC) explicitly excludes - as being contrary to public order and morality - the use of human embryo's for industrial or commercial purposes. Therefore Greenpeace is of the opinion that Brüstle's invention should be excluded from patentability.

One of Brüstle defenses against this argument was that it was not necessary to destroy human embryo's in order to obtain pluripotent embryonic stem cells. According to Brüstle such cells can also be obtained by transplanting an unfertilized human ova with a cell nucleus from a mature cell, or by stimulating an unfertilized human ova into further developments by means of parthogenesis. However, both methods have in common that they lead to totipotent embryonic stem cells (like normal fertilized human ova). In a further stage of development (the so-called blastocyst stage) these cells become pluripotent, and may then be used for the invention. Also in this case the further development of the cell mass from which the pluripotent cells are obtained is disturbed.

Greenpeace argues that both methods lead to totipotent cells - capable of developing into a human being - and that these totipotent cells and all stages of development that follow, are to be regarded as a human embryo. As these embryo's will be destroyed when pluripotent embryonic stem cells are obtained, this still falls under the exclusion of Article 6(2)(c), according to Greenpeace.

Further points of debate were the questions whether the exclusion of the use of human embryos 'for industrial and commercial purposes' also encompasses using embryos for scientific research, and whether the exclusion also applies when the use of the human embryo is not part of the technical teaching of the patent, but is a precondition for the application of said teaching.

Preliminary questions

In the light of this debate, the German Federal Supreme Court (Bundesgerichtshof) decided to refer the following questions to the ECJ:

1. What is meant by the term "human embryos" in Article 6(2)(c) of [the Biotech Directive]?

(a) Does it include all stages of the development of human life, beginning with the fertilisation of the ovum, or must further requirements, such as the attainment of a certain stage of development, be satisfied?
(b) Are the following organisms also included?
- unfertilised human ova into which a cell nucleus from a mature human cell has been transplanted;
- unfertilised human ova whose division and further development have been stimulated by parthenogenesis?
(c) Are stem cells obtained from human embryos at the blastocyst stage also included?

2. What is meant by the expression "uses of human embryos for industrial or commercial purposes? Does it include any commercial exploitation within the meaning of Article 6(1) of [the Biotech Directive], especially use for the purposes of scientific research?

3. Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the Directive even if the use of human embryos does not form part of the technical teaching claimed with the patent, but is a necessary precondition for the application of that teaching?

(a) because the patent concerns a product whose production necessitates the prior destruction of human embryos,
(b) or because the patent concerns a process for which such a product is needed as base material?

Judgment of the European Court of Justice

The Court of Justice answers the questions as follows.

1. Article 6(2)(c) of [the Biotech Directive] must be interpreted as meaning that:

– any human ovum after fertilisation, any non-fertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any non-fertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute a 'human embryo';
– it is for the referring court to ascertain, in the light of scientific developments, whether a stem cell obtained from a human embryo at the blastocyst stage constitutes a 'human embryo' within the meaning of Article 6(2)(c) of Directive 98/44.

2. The exclusion from patentability concerning the use of human embryos for industrial or commercial purposes set out in Article 6(2)(c) of [the Biotech Directive] also covers the use of human embryos for purposes of scientific research, only use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it being patentable.

3. Article 6(2)(c) of [the Biotech Directive] excludes an invention from patentability where the technical teaching which is the subject-matter of the patent application requires the prior destruction of human embryos or their use as base material, whatever the stage at which that takes place and even if the description of the technical teaching claimed does not refer to the use of human embryos.

The fact that the ECJ rules that inventions for which it is necessary to destroy a human embryo are not patentable - even if this is not part of the patent claims or description - is not surprising . In its decision in case G 2/06 the Enlarged Board of Appeal of the European Patent Office ("EPO") came to the same conclusion, and the ECJ largely follows the conclusion of its Advocate General in the present case.

However, other than the EPO, the ECJ also ruled on the question whether artificially created (totipotent) stem cells also fall under the definition of human embryo. The fact that the ECJ rules that such stem cells are also to be regarded as human embryos and that inventions that necessitate the destruction of such cells are not patentable, may have significant impact on commercial stem cell research in Europe.

It is noted that insofar it is or will become possible to obtain pluripotent stem cells without destroying an entity that was capable of developing into a human being, inventions like that of Oliver Brüstle may be patentable after all.

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.

Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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