involving human embryonic stem cells are difficult to interpret, mainly due to the
lack of definitions of some very important terms and concepts encompassed by
those provisions. The CJEU, which is the main authority for interpreting European
law, has so far issued two decisions in which it tried to clarify Article 6 paragraph
2 item (c) of the Directive. Whether the Court succeeded in decomplicating the
issue will be discussed in the following sections.
4.2.1 CJEU Decision in Oliver Br€ustle
The CJEU first had the opportunity to shed light on the reach of Article 6 paragraph
2 item (c) of the Directive in case C 34/10 Oliver Br€ustle versus Greenpeace eV, in
which the Court’s judgement was issued on 18 October 2011.^44 In December 1997,
Mr. Br€ustle filed a patent application in Germany for an invention that concerned
isolated and purified neural precursor cells obtained from embryonic stem cells,
which were, in turn, initially obtained from an early embryo. The application stated
that a transplantation of those cells into the nervous system is a promising treatment
method of numerous neurological conditions such as Parkinson’s disease. Since in
nature such cell type can only be found during an early stage of development of the
brain, the invention was intended to solve the technical problem of producing an
unlimited number of isolated and purified precursor cells for treatment. Nowhere
did the patent application refer to the use of a human embryo. The patent was
granted, but soon after Greenpeace requested that it be declared invalid, claiming
breach of ordre public and morality. The German Federal Patent Court
(Bundespatentgericht) then declared the patent invalid, explaining that the inven-
tion is immoral, since it embraces precursor cells obtained from human embryonic
stem cells. The patent applicant filed an appeal against this decision to the Federal
Court of Justice (Bundesgerichtshof). This Court stated that the concept of an
embryo used in the legal system of a particular EU member state cannot be
interpreted differently from the corresponding concept from Article 6 paragraph
2 item (c) of the Directive on Patents in Biotechnology. Considering that the CJEU
did not prior to that point in time interpret this concept from the Directive, on
12 November 2009, the Federal Court of Justice referred several questions to the
CJEU in relation to the interpretation of the Directive. Those questions were as
follows:
- What is meant by the term “human embryos” in Article 6(2)(c) of [the Directive]?
(a) Does it include all stages of the development of human life, beginning with the
fertilisation of the ovum, or must further requirements, such as the attainment of a
certain stage of development, be satisfied?
(b) Are the following organisms also included:
- unfertilised human ova into which a cell nucleus from a mature human cell has been
transplanted;
(^44) CJEU ( 2011 ).
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 71