The Patentability of Stem Cells in Europe: The Decision

Last year, we reported that the German Federal Patent Court had referred questions concerning the interpretation of Article 6 of Biotechnology Directive, to the European Court of Justice (ECJ).

The Biotechnology Directive states:

“1. Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality; however, exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation.

2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable…..(c) uses of human embryos for industrial or commercial purposes.”

The German judge felt that more legal clarity was needed on the issue of the interpretation of the terms “human embryo” and “uses of human embryos for industrial and commercial purposes”.  In particular, is was asked whether a “human embryo” includes all stages of development beginning with the fertilisation of the ovum, or whether attainment of a certain development stage is required; and whether stem cells derived from an unfertilised human ova, or from a blastocyst, are still considered to be an embryo.

The ruling of the ECJ was published on 10 March 2011 and the Curia press release has provided the following summary of the decision (which is not yet available in English).

The Advocate General confirmed that an invention cannot be patentable where the application of the technical process for which the patent is filed necessitates the prior destruction of human embryos or their use as base material, even if the description of that process does not contain any reference to the use of human embryos.  However, the patentability of uses of human embryos for industrial or commercial purposes is not prohibited under the directive where it concerns only inventions for therapeutic or diagnostic purposes which are applied to the human embryo and are useful to it – for example to correct a malformation and improve its chances of survival.

Getting into the technical detail of the question asked of the ECJ, the Advocate General made the following observations.  Totipotent cells, appearing after fusion of the gametes and existing in that form only for the first days of development, have the essential characteristic of carrying within each of them the capacity to develop into a complete human being.  Thus those cells, since they represent the first stage of the human body which they will become must be legally classified as embryos, the patentability of which must be excluded.  This definition therefore covers unfertilised ova into which a cell nucleus from a mature cell has been transplanted and unfertilised ova whose division has been stimulated by parthenogenesis in so far as totipotent cells would be obtained in those ways.

Similarly, the blastocyst stage of development, reached around five days after fertilisation, must also be classified as an embryo, since, according to the Advocate General, the principle of human dignity, to which the directive refers, is a principle which must be applied not only to an existing human person, to a child who has been born, but also to the human body from the first stage in its development, i.e. from fertilisation.

By contrast, pluripotent embryonic stem cells, taken in isolation, do not fall within the definition of an embryo, since, individually, they are no longer capable of developing into a complete human being.  They can 'only' differentiate themselves into various organs forming parts of the human body.  However, the Advocate General concluded, it is not possible to ignore the origin of these embryonic stem cells.  The fact that they come from some stage in the development of the human body is not in itself a problem, provided that their removal does not result in the destruction of that human body at the stage of its development at which the removal is carried out.

Whilst not bound by decisions of the ECJ, the European Patent Office (EPO) is expected to take note of this ruling and the clear technical guidance it provides.  Therefore, we would expect the EPO to make an announcement on how this will affect their practice regarding the patentability of stem cells in the near future.  Policy statements are also likely to come from national patent offices within the European Union.  We will, of course, keep you abreast of developments.

In the meantime, if you would like any more information about this subject, please do not hesitate to contact Siân Gill.

Relevant links:
•    The ECJ decision in full
•    The Curia press release in full

Siân Gill 11 Mar 2011

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