The Advocate General has published an opinion concerning the interpretation of certain terms contained in Directive 98/44/EC, the “Biotech Directive”. In particular the opinion focussed on interpretation of the term “human embryo”. The AG considered that totipotent cells, those which have the capacity to evolve into complete human beings, as well as cells at the blastocyst stage of development, must be classified as human embryos and are therefore not patentable. In addition, procedures using pluripotent embryonic stem cells that necessitate destruction or modification of an embryo would not be patentable.

The AG considered that the principle of ‘human dignity’ within the Directive should be applied from fertilisation. Therefore, the definition of ‘human embryo’ must include totipotent cells and the blastocyst stage of development (about 5 days post fertilisation). Conversely, pluripotent embryonic stem cells which, taken in isolation, are individually not capable of developing into complete human beings, are not ‘human embryos’. Therefore, processes using such cells are patentable, provided they are not obtained to the detriment of an embryo. The AG further considered that it does not make a difference whether the description in the patent contains references to the use of human embryos. If the application of the technical process necessitates prior destruction of human embryos or their use as a base material, it is against public policy, and any such invention is not patentable.

The AG noted, however, that the use of human embryos is not prohibited where it concerns inventions for therapeutic/diagnostic purposes which are applied to the human embryo and are useful to it.

This opinion is important as it is the first time the Court of Justice has been called upon to consider the interpretation of these terms. The ruling of the Court of Justice of the European Union will be given at a later date.

Click here to read the CJEU judgment (C34/10) in full.

Click here to read the Curia Press Release.