- unfertilised human ova whose division and further development have been stimulated by
parthenogenesis?
(c) Are stem cells obtained from human embryos at the blastocyst stage also included?
- What is meant by the expression “uses of human embryos for industrial or commercial
purposes”? Does it include any commercial exploitation within the meaning of Article 6
(1) of [the Directive], especially use for the purposes of scientific research? - Is technical teaching to be considered unpatentable pursuant to Article 6(2)(c) of the
Directive even if the use of human embryos does not form part of the technical teaching
claimed with the patent, but is a necessary precondition for the application of that
teaching:
- because the patent concerns a product whose production necessitates the prior destruction
of human embryos, - or because the patent concerns a process for which such a product is needed as base
material?
In relation to the first question, the CJEU opted for a very broad definition of an
embryo, emphasizing that the definition is given solely for the purposes of
interpreting the Directive on Patents in Biotechnology. The Court stated that the
term human embryo for the purposes of the Directive encompasses not only
fertilized human ova but also “any non-fertilised human ovum into which the cell
nucleus from a mature human cell has been transplanted and any non-fertilised
human ovum whose division and further development have been stimulated by
parthenogenesis.”^45 The reasoning behind the inclusion of embryos created by
somatic cell nuclear transfer and parthenogenesis into the equation was that “they
are, as is apparent from the written observations presented to the Court, capable of
commencing the process of development of a human being just as an embryo
created by fertilisation of an ovum can do so.”^46 Concerning human embryonic
stem cells, the Court stated that “it is for the referring court to ascertain, in the light
of scientific developments, whether a stem cell obtained from a human embryo at
the blastocyst stage constitutes a‘human embryo’within the meaning of Article 6
(2)(c) of the Directive.”^47
The CJEU’s decision to define an embryo so broadly was surprising to many,
including to the author of this chapter. Namely, it is questionable if it is legally
correct to define entities created by somatic cell nuclear transfer or parthenogenesis
as embryos for the purposes of the Directive since it is clear from the Directive that
embryos enjoy a special status primarily due to the fact that they represent potential
human beings,i.e., they are a stage in the formation and development of human
(^45) See CJEU ( 2011 ), para. 38.
(^46) See CJEU ( 2011 ), para. 36.
(^47) See CJEU ( 2011 ), para. 37. In its decision that followed the CJEU’s judgement, the referring
court—theBundesgerichtshof—stated that human embryonic stem cells are patentable because
they cannot lead to the development of a human being according to the state of the art, provided
that a fertilized ovum was not destroyed for producing the embryonic stem cells. See Dombrowski
( 2012 ). Such a decision was expected because there aren’t any available scientific studies proving
that human embryonic stem cells are capable of commencing the process of the development of a
human being. Therefore, for now, they should not be considered embryos, even under the broad
CJEU’s definition.
72 J. Mutabžija