Court of Justice clarifies exclusion against patenting of embryonic stem cells

Under Article 5 of EU Directive 98/44/EC the “Biotech Directive”, the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. However an element isolated from the human body or otherwise produced by means of a technical process, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

Under Article 6 of the Biotech Directive, inventions shall be considered unpatentable where their commercial exploitation would be contrary to public order or morality. In particular it prohibits uses of human embryos for industrial or commercial purposes.

The judgment (C-34/10) concerned the patentability of an invention which had been patented in Germany by the University of Bonn for converting human embryonic stem cells in the form of neural precursor cells into nerve cells for the treatment of a variety of conditions including Parkinson’s disease. The reference to the CJEU had been made in the course of proceedings brought by Greenpeace seeking annulment of the German patent.

The CJEU’s ruling is broadly consistent with the Advocate General’s opinion which was published in March 2011 concerning the interpretation of certain terms contained in the Biotech Directive.

The CJEU first considered the meaning of ‘human embryo’ under the Biotech Directive. In doing so, the Court confirmed that it was not its role to answer questions of a medical or ethical nature, but was restricted to a legal interpretation of the relevant provisions of the Directive.

The Court took the view that the term ‘human embryo’ should be given a broad meaning to give effect to the purpose of the legislation and 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 all fall within the term ‘human embryo’ as they are capable of commencing the process of development into a human being.

Further, 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 or the teaching of the invention requires the destruction of human embryos. In that case too, the view must be taken that there is use of human embryos. 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, is irrelevant.

The CJEU also confirmed that the exclusion from patentability concerning use of human embryos also covers use for purposes of scientific research, with the exception that use for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it are patentable.