Personalized_Medicine_A_New_Medical_and_Social_Challenge

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commercial purposes,” which are unpatentable in accordance with Article 6 para-
graph 2 item (c) of the Directive. The ISCC, however, appealed this decision
insisting that it be clarified what the CJEU meant by saying that parthenotes were
capable of commencing the process of development of a human being—did it mean
“capable of commencing the process of development that could lead to a human
being,” or did it mean “capable of commencing the process of development even if
that process is incapable of leading to a human being?”^59 The Comptroller agreed
that the test formulated by the CJEU was not sufficiently clear and that the written
observations lodged with the CJEU in the Oliver Br€ustle case may have inaccu-
rately presented the scientific and technical background relating to parthenogene-
sis.^60 Therefore, the High Court submitted the following question to the CJEU:


Are unfertilised human ova whose division and further development have been stimulated
by parthenogenesis, and which, in contrast to fertilised ova, contain only pluripotent cells
and are incapable of developing into human beings, included in the term‘human embryos’
in Article 6(2)(c) of Directive 98/44...?
Following the Advocate General’s opinion, in which it was stated that in order to
be classified as a “human embryo” a nonfertilized human ovum must necessarily
have the inherent capacity of developing into a human being, the CJEU indirectly
admitted the mistake it had made in Oliver Br€ustle but blamed the mistake on the
written observations presented to the Court, which apparently lead the Court to
conclude then that parthenotes as such inherently had the capability of developing
into a human being and should, therefore, be treated in the same way as a fertilized
ovum.^61 In the present case, the CJEU basically stated that if according to current
scientific findings a human parthenote in itself, without additional genetic manip-
ulation, did not have an inherent capability of developing into a human being, then
it could not be considered a human embryo in the meaning of the Directive. The
CJEU left to the referring court to decide whether parthenotes have such inherent
capability or not.^62
This is certainly a welcome clarification of the Court since the decision in Oliver
Br€ustle was so restrictive that it basically banned patenting in all crucial areas of
human embryonic stem cell research, thus completely disregarding the objectives
of the very Directive it was intended to interpret. The CJEU’s decision in ISCC
brings some hope for human embryonic stem cell researchers. However, the
decision in ISCC, useful as it is, also opens new questions and reopens some old
ones, such as when is it considered that an organism develops into a human being—
at birth or at some point before that? In other words, what is the definition of a
human being? Furthermore, does the same reasoning apply to entities created by
somatic cell nuclear transfer, which are, according to the current state of the art, also


(^59) See CJEU ( 2014 ), paras 14 and 15.
(^60) See CJEU ( 2014 ), para. 16.
(^61) See CJEU ( 2014 ), paras 31, 32, and 33.
(^62) See CJEU ( 2014 ), para. 38.
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 75

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