Brussels, 11/03/2011 (Agence Europe) - On 10 March, Advocate General Yves Bot returned important conclusions in Case C-34/10 on the interpretation of the notion of “human embryo”, a first for the Court, which was asked for the first time to take position on a notion which is not defined by Directive 98/44/EEC (legal protection of biotechnological inventions) and, more specifically, on the notion of “use of the human embryo for industrial or commercial purposes” contained in the directive. This is a particularly sensitive area, where the stakes are not just moral and human but also economic and financial, and where the case law of the member states diverges. In this case, the question was whether the exclusion of the human embryo from patentability concerns all stages of life from the moment the egg is fertilised, or whether other conditions need to be satisfied, such as a certain stage of development having been reached.
Yves Bot points out that the directive does not ban the patentability of uses of human embryos for industrial or commercial purposes for inventions to be used for therapeutic or diagnostic purposes applied to the human embryo and useful to it, for example, to correct a malformation and improve its chances of survival. However, the principle of human dignity, which is contained within the directive, applies not only to existing human beings, but also to the human body in the first stages of its development, in other words fertilisation.
On this basis, he takes the view that totipotent cells, which appear after the fusion of the gametes and which exist in this form only for the first days of development, must be described as human embryos and excluded from patentability, as they carry within them the capacity to evolve into a complete human being. The embryo description must also be applied to the blastocyst stage of development, a subsequent stage in the development of the embryo (around five days after fertilisation).
By contrast, different embryonic stem cells, known as pluripotent cells, taken in isolation, do not fall within the definition of embryos, as they are individually no longer capable of developing into a complete human being and can “only” differentiate themselves into various organs forming parts of the human body.
However, he continues, removing these cells should not result in the destruction or alteration of the human body at the stage of its development when the cells were removed. Consequently, an invention using pluripotent stem cells, the harvesting of which would result in the destruction or alteration of an embryo, must be excluded from patentability. Indeed, to give an industrial application to an invention which uses embryonic stem cells would be tantamount to using human embryos as a simple base material, which would be contrary to ethics and public order.
Whilst making clear that the directive does not outlaw the patentability of using human embryos for industrial or commercial purposes for therapeutic or diagnostic purposes applied to the human embryo and useful to it - for example to correct a malformation and improve its chances of survival - the advocate general concludes that an invention cannot be patentable if the implementation of the procedure necessitates the prior destruction of human embryos or them to be used as base material, even if the description of that process does not contain any reference to the use of human embryos. (F.G./transl.fl)