Decision of CJEU limits patentability of human embryonic stem cells techniques

The court ruled that exclusion from patentability of stem cell techniques that use human embryos for industrial or commercial purposes includes research purposes. The court further ruled that any human ovum stimulated by fertilization or parthenogenesis to further development and carrying the capacity to develop into a complete human constitutes a human embryo. The court referred back to the national court to decide, in the light of scientific developments, whether a stem cell obtained from a blastocyst is to be considered as a human embryo.

Background

Stem-cells are found in almost all multi-cellular organisms. Stem cells are totipotent or pluripotent: that is, they have the ability to renew themselves and to differentiate into a complete organism (=totipotent) or they have the ability to differentiate into a diverse range of specialized cell types (=pluripotent). There are two types of mammalian stem cells: embryonic stem cells, found in embryos, and adult stem cells, found in various tissues. Embryonic stem cells differentiate into embryonic tissue during the development of the embryo. Adult stem cells form a repair system and maintain the turnover of regenerative organs such as blood, skin and intestinal tissue.

Referral to the Court of Justice of the European Union

The German Federal Court of Justice has in 2009 referred several questions on the patentability of human stem cell related inventions to the CJEU. Previously, the German Patent Court (Bundesgerichtshof) had declared a patent of Mr. Brüstle relating to isolated and purified neural precursor cells invalid insofar as it relates to obtaining the precursor cells from human embryos. Mr. Brüstle appealed the decision and the German Federal Court stayed the proceedings for referring interpretation questions to the CJEU. Namely, Mr. Brüstle had inter alia pleaded that the stem cell lines according to his invention were harvested from blastocysts 4-5 days after fertilization while according to several European countries the term embryo is only used starting from 14 days after fertilization. Hence, the stem cell lines according to his invention would not be harvested from embryos, because a blastocyst is not an embryo yet. The European Parliament and Council Directive 98/44/EC on biotechnology inventions, which is implemented through Rules 26 and 28 EPC into the European Patent Convention (EPC), dictates in Article 6(2)(c) that “use of human embryos for industrial or commercial use shall be considered unpatentable”. However, there is no definition of the term “human embryo” in the Directive.

In the light of the debate, the German Federal Court decided to refer the following questions to the CJEU:

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, more in particular, does it include 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, or

(b)  because the patent concerns a process for which such a product is needed as base material?

Judgment of the Court of Justice of the European Union

The CJEU answered the questions as follows:

1.  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 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 are patentable.

3.  An invention is excluded 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 second part of the answer to question 1 actually seems (presently) not relevant for the outcome of the patentability of a stem cell. Whether a national court may consider that a stem cell obtained from a human embryo at the blastocyst stage constitutes a human embryo itself within the meaning of Article 6(2)(c) of Directive 98/44 or not seems irrelevant since the blastocyst is considered a human embryo and the blastocyst is used in the process of obtaining the stem cell. Ergo, such stem cell obtained from the blastocyst stage is not patentable.

Answer 3 of the CJEU seems to be in agreement with the earlier decision of the Enlarged board of Appeal. In its decision in case G 2/06 the Enlarged Board of Appeal of the European Patent Office came to the same conclusion that whenever the subject matter requires the prior destruction of human embryos or their use as base material, even if this has occurred in a stage long before the actual subject matter of the patent application, the subject matter is excluded from patentability.  Not to exclude from patentability such an invention would allow a patent applicant to avoid the non-patentability by skilful drafting of the claim.

Implications

The decision will have an impact on embryonic stem cell research as it bans the patentability on almost any invention relating to embryonic stem cell techniques in Europe.

Other than the EPO, the CJEU also ruled on the question whether artificially created (totipotent) stem cells fall under the definition of human embryo as well. The fact that the CJEU 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.

However, 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 Mr. Brüstle may be patentable after all. 

Authors:

• Thea van de Wijk
• Peter ten Haaft

Link: full text of the decision