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

Background

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.

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