Court of Justice of the European Union to decide again on the patentability of embryonic stem cells

02 March 2010

Dr Susanne Ulmar

In its decision of 17 December 2009, the German Federal Court of Justice referred several questions regarding the patentability of embryonic stem cells to the Court of Justice of the European Union (formerly the European Court of Justice). 

By way of background, a German scientist had a German patent protecting isolated and purified neural precursor cells, methods for their generation from embryonic stem cells and the use of the neural precursor cells to treat neural defects. 

Greenpeace filed a complaint against this patent and requested it be declared invalid due to violation of the public order to the extent that the patent covers precursor cells which are obtained from human embryonic stem cells.  

The German Federal Patent Court upheld this complaint to the predominant extent. The patentee appealed this decision to the German Federal Court of Justice. The German Federal Court of Justice stayed the proceedings and referred several questions to the Court of Justice of the European Union.

The German Federal Court of Justice arrived at the conclusion that the decision on the nullity action depended on whether the alleged invention is excluded from patent protection pursuant to the German Patent Act to the extent that precursor cells are concerned which are obtained from embryonic stem cells. The German Patent Act inter alia excludes from patent protection the use of human embryos for industrial or commercial purposes. This again depends on the interpretation of the European Directive 98/44/EC (Biotechnological Inventions Directive), which has been implemented into national law by means of this rule of exclusion.

Pursuant to the opinion of the German Federal Court of Justice, it is particularly relevant in these proceedings what “human embryos” are within the meaning of the Directive. It is in particular relevant whether embryonic stem cells, which are obtained from embryos at the blastocystic stage, are to be regarded as “embryos” as such stem cells do not have the ability to develop into a complete individual by that stage. Also, the question arises whether at least the blastocysts themselves, from which such stem cells are extracted, have to be regarded as human embryos within the meaning of the Directive. The decisive factor for this is whether the term “embryo” covers all development stages of human life starting from the fertilisation of the egg cell, or whether a fertilised egg cell has to be regarded as an “embryo” within the meaning of the Directive only when it reaches a later stage of development.

Furthermore, the German Federal Court of Justice felt it important to consider at what point one would talk about “use for industrial or commercial purposes“ for the purposes of the Directive and in particular whether any commercial utilisation, including the use for research purposes, should be covered. 

Finally, the German Federal Court of Justice is faced with the issue whether a “use of embryos” within the meaning of the Directive requires the use of the embryos itself to be part of the technical teaching claimed in the patent. This is relevant for the question of whether the exclusion rule also applies if the use of human embryos is not a part of the patent claim, but is a necessary requirement for it.

In this regard the European Patent Office decided a short while ago in connection with the so-called “WARF” patent that patent protection for products, which at the date of application could only be produced by a method that inevitably involves destroying human embryos, is excluded.  

It remains to be seen whether the Court of Justice of the European Union will assume a similarly restrictive approach or whether it applies a broader interpretation to the exclusion of patentability of human embryos.