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Patentability of embryonic stem cells in Europe

What is an embryo? Advocate General M. Yves Bot has provided his opinion on this in case C-34/10 (Brüstle v Greenpeace).

Mr. Brüstle was the owner of a German patent concerning the use of neuronal precursor cells for the treatment of neuronal defects. This patent was invalidated by the German Court because the neuronal precursor cells were produced from embryonic stem cells. During the appeal procedure, the German Federal Court of Justice decided to refer questions to the Court of Justice of the European Union concerning the interpretation of the term “human embryo” because this has not been defined in Council Directive 98/44/EC. Particularly, it was questioned whether the term “embryo” included all stages from the fertilization of the ovum.

Directive 98/44/EC intends to harmonize legal protection of biotechnological inventions in the European member states. In this Directive the use of human embryos for industrial or commercial purposes is declared unpatentable unless therapeutic or diagnostic methods are useful to the embryo itself. However, the term “embryo” is not described in any further detail.

Advocate General Bot has pointed to Article 5 of the Directive which states that the human body at the various stages of its formation and development cannot constitute patentable inventions. He therefore considers it clear that totipotent cells, which exist only the first days after fertilization and which each have the capacity to develop into a complete human being, must be legally classified as embryos. The same holds true for the blastocyst stage of development which is reached around five days after fertilization.
Another kind of stem cell, however, referred to as the pluripotent embryonic stem cell, is not capable of developing into a complete human being. They can develop into human organs. Therefore, these cells are not considered embryos by the Advocate General so that their use could, in principle, be patentable. However, the Advocate General has added the provision that this is only allowable if the pluripotent stem cells are not obtained to the detriment of an embryo. If the isolation of these cells results in the destruction or modification of the embryo, their use is not considered patentable either.

Generally, the European Court of Justice will follow the opinion of the Advocate General. However, it remains to be seen if the Court maintains this practice in such a highly controversial issue.