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Brüstle v Greenpeace – The Patentability of Stem Cells in Europe

In our Spring/Summer newsletter, we reported the preliminary Opinion of the Advocate General of the Court of Justice of the EU (CJEU) concerning Brüstle v Greenpeace (C-34/10), relating to the patentability of stem cells in Europe. The CJEU has, this morning, now issued its Decision on this case. This Decision is not binding on the European Patent Office (EPO), but it is expected to take note of it, and EPO examiners are likely to follow the ruling when examining the claims of European patent applications.

By way of background, Professor Brüstle, a neuropathologist and renowned expert in stem cell research, had invented a way to produce, from embryonic stem cells, specialised cells for treating neurological conditions, such as Parkinson's disease. He obtained a patent, which was subsequently opposed by Greenpeace. The German Federal Patent Court referred certain questions to the CJEU concerning the interpretation of the European Biotechnology Directive (98/44/EC). In particular, Article 6 of the Directive precludes patentability for certain biotechnological inventions, including “uses of human embryos for industrial or commercial purposes”. However, rather unhelpfully, the Directive does not provide a definition of the term “human embryo”, and so it was left to the CJEU to provide such a definition, in this ruling.

The first question considered by the CJEU therefore was to provide a definition of the term “human embryo”, and whether or not it encompasses the ovum from initial fertilisation, or perhaps some later stage of development is required. The Court held that the concept of “human embryo” should be construed broadly, and therefore it took the view that any human ovum must be regarded as being a “human embryo”, as soon as it is fertilised, if that ovum could develop into a human being. The Court also confirmed that the term “human embryo” includes cells that are produced by artificial methods, such as those that were used to create Dolly the sheep, and which can commence the development into a human being.

Although the CJEU was asked to consider if “human embryo” also covers pluripotent stem cells removed from the blastocyst, as in Brüstle’s invention, the Court explained that it did not have to consider questions of a medical or ethical nature, such as this, and should instead restrict itself to a legal interpretation of the relevant provisions of the Directive. Therefore, the Court chose not to decide on this issue, and held that it is for the referring court (the German Court, in Brüstle’s case) to ascertain, in the light of scientific developments, whether or not they are capable of commencing the process of development of a human being and, therefore, are included within the concept of “human embryo”. It is noteworthy that the Advocate General had, in his Opinion to the Court, which issued on 10 March 2011, taken the view that pluripotent embryonic stem cells should not be regarded as “human embryos”, because they are, in contrast to totipotent cells, incapable of developing into a human being, and that inventions relating to pluripotent stem cells can be patentable, but only if they are not obtained to the detriment of an embryo, including its destruction or its modification.

The CJEU was also asked to decide what is meant by the expression “uses of human embryos for industrial or commercial purposes”, as used in Article 6 of the Directive, and whether or not there was a distinction between using embryos for scientific research (as in Brüstle’s patent) and using them in a purely commercial process. The CJEU has held that the uses of human embryos for therapeutics or diagnostic purposes, which are applied to the human embryos, and are useful to it, are patentable. However, their use purely for the purposes of scientific research is not patentable.

The final question put to the CJEU concerned the patentability of stem cells when the patent is silent on using human embryos, but they are nevertheless required. The situation addressed by this question is where the patent does not mention the use of human embryos in its description, but there is a supposition that firstly, stem cells are obtained from a human embryo at the blastocyst stage and, secondly, that the removal of a stem cell results in the destruction of that embryo. The Court has held that an invention is excluded from patentability where the implementation of the process requires either the prior destruction of human embryos, or their prior use as base material, even if, in the patent application, the description of that process, as in the Brüstle case, does not refer to the use of human embryos.

In summary, the CJEU’s Decision has largely followed the Advocate General's Opinion, giving a broad interpretation of the term “human embryo”, though it is odd that the Court refused to reiterate the Advocate General’s Opinion that pluripotent cells are not regarded as human embryos. It seems that, for a stem cell not to be regarded as a human embryo, it must not be capable of developing into a human being. Furthermore, for a stem cell to be patentable, it should be obtained by a method which does not involve the destruction of a human embryo.

Anton Hutter 17 Oct 2011

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