Tuesday, December 13, 2011

The End of Embryonic Stem Cell Research in Europe? The European Court of Justice Decision, Case C-34/10, October 18, 2011

The European Court of Justice (“ECJ”) ruled in the case Brüstle v. Greenpeace (Case C-34/10) brought up by Greenpeace seeking annulment of the German patent – Patent No. DE19756864C1 – held by Mr. Brüstle concerning isolated and purified neural precursor cells, processes for their production from embryonic stem cells and the use of neural precursor cells for the treatment of neural defects. The main focus of the decision is the interpretation of Article 6(2)(c) of Directive 98/44/EC (1998 OJL (L213) 13-18) of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions.

The German Federal Patent Court (Bundespatentgericht, “BPatG”) ruled on December 5, 2006, Case 3 Ni 42/04, on the basis of Paragraph 22(1) German Patent Protection Act (“PatG”) in conjunction with Paragraph 21 Subsection 1 Point 1 PatG in conjunction with Paragraph 2 Subsection 2 Point 3 PatG, that the patent at issue is invalid in so far as it covers precursor cells obtained from human embryonic stem cells and processes for the production of those precursor cells. The court held that the patent also violates the German Embryonic Protection Act (“ESchG”), which prohibits research with human embryos. Mr. Brüstle appealed against the judgment to the German Federal Court of Justice (Bundesgerichtshof, “BGH”), December 17, 2009, Case Xa ZR 58/07.

In accordance with the guiding principles of European Union Law, the national law of the Member States must be interpreted in terms of the rules and regulations set by the European Union; the court held that the outcome of the application for the annulment of the patent de-pends on the interpretation of Article 6 of the Directive, which is implemented in the PatG as well as the ESchG. Thus, the BGH referred specific questions to the ECJ and requested a preliminary ruling regarding:

1. the interpretation of the term “human embryos” in Article 6(2)(c) of the Directive;
2. the interpretation of the expression “uses of human embryos for industrial or commercial purposes” and the question if this especially includes the use for the purposes of scientific research;
3. and if an invention is unpatentable even if the use of human embryos does not form part of the technical teaching claimed with the patent, but whose production necessi-tates the prior destruction of human embryos. See, in detail: Bundesgerichtshof [BGH] [German Federal Court of Justice], December 17, 2009, Case Xa ZR 58/07; ECJ, October 18, 2011, Case C-34/10, para. 23.

The Concept of Human Embryo

Because the Directive lacks a definition of the term “embryo” and after considering the preamble and the scope of the directive, the court ruled:
"any human ovum after fertilisation, any nonfertilised human ovum into which the cell nucleus from a mature human cell has been transplanted, and any nonfertilised human ovum whose division and further development have been stimulated by parthenogenesis constitute[s] a human embryo" (Case C-34/10, para. 53);

"stem cells obtained from a human embryo at the blastocyst stage, […] whether they are capable of commencing the process of development of a human being, […] are included within the concept of human embryo” (Case C-34/10, para. 37).

Human Embryos for Scientific Research

The Directive is limited to the patentability of biotechnological inventions; it does not regulate the use of human embryos in the context of scientific research directly. Considering Recital 14 of the Directive, the court ruled:
"[the] use of human embryos for industrial or commercial purposes' within the meaning of Article 6(2)(c) of the Directive also covers use for purposes of scientific research" and are not patentable;

"only use[s] for therapeutic or diagnostic purposes which [are] applied to the human embryo and are useful to it [are] patentable". (Case C-34/10, para. 46)

Inventions Based on the Destruction of Human Embryos

Taking into account that a human embryo is destroyed when a stem cell is removed during the blastocyst stage, for example, in the production of neural precursor cells (Case C-34/10, para. 48), the court held that when the destruction occurs at a stage long before the implementation of the invention it is irrelevant (Case C-34/10, para. 49). Therefore, the court ruled:
"an invention must be regarded as unpatentable, even if the claims of the patent do not concern the use of human embryos, where the implementation of the invention requires the destruction of human embryos" (Case C-34/10, para. 49);

"the fact that destruction may occur at a stage long before the implementation of the invention, as in the case of the production of embryonic stem cells from a lineage of stem cells the mere production of which implied the destruction of human embryos is, in that regard, irrelevant" (Case C-34/10, para. 49).

This recent decision may do more to impede the progress of embryonic stem cell research in Europe than any inherent limits in the state of science itself. The court used a very broad definition of the term “embryo” without using any scientific reference points. With its definition of “embryo” the court included nearly all possible stages in the development. Although, the court recognized that non-fertilized ova are incapable of developing into a human being, it nonetheless placed them on the same level as an embryo. The implications of this decision are widespread in Europe; the decision is binding and cannot be appealed. It remains to be seen how the German courts and legislature, as well as those of the other Member States will react and comply.

-- Bianca Buechner, Ph.D., LL.M. Candidate
Indiana University Robert H. McKinney School of Law


Christian Munthe said...

Thank you, very interesting. Together with the piece in The Guardian today, this the first more systematic account to analyse the ECJ decission in legal terms. Just one small think. I don't think it is entirely correct to talk about unfertilised ova in this context, since what is referred is the end-result of what is known as somatic cell nuclear transfer, i.e. the same technique used for what in the populat press is called cloning. It is not reproductive cloning, since the end-product of the NT is never transfered into a uterus, but left in the lab to develop until the cells are pluripotent. However, had it been so transferred it may very well have resulted in pregnancy (no known attempt has been made on humans, so we can't be sure, of course, but it is at least as likely as in the cases involving higher mammals)). In effect, it seems that the product of performing NT on an unfertilised ovum would have to be equated with a zygote in a lab. Not that this changes much of your argument, though.

Bianca Buechner, Ph.D., LL.M. said...

Dear Professor Munthe,

Thank you very much for your very interesting comment. I really appreciate your feedback. Your comment demonstrates that the ECJ has been too brief in its explanation of the term "human embryo." The ECJ's use of "human embryo" leaves too much room for interpretation. The variable (and sometimes incorrect) use of the term will challenge the European Union's goal of consistency in this special field of research. I would be delighted to hear more of your thoughts on this topic.

-- Bianca Buechner