Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

bodies.^48 However, regardless of what was presented to the Court, it is common
ground that according to the current state of the art, the likelihood of birth if such
nontraditional embryos were to be implanted into a womb is either extremely slim
and purely theoretical in the case of somatic cell nuclear transfer or virtually
nonexistent in the case of parthenogenesis.^49 Therefore, it is difficult to argue that
those entities also represent potential human beings or a stage in the formation and
development of human bodies, especially those entities created by parthenogenesis,
which cannot lead to birth because the genes of the Y chromosome are completely
absent.
As to the second question, the CJEU correctly concluded that the concept of
“industrial or commercial purposes” also covers the use in scientific research.
Similarly to the argumentation put forward in one of the previous sections of this
chapter, the Court stated that “although the aim of scientific research must be
distinguished from industrial or commercial purposes, the use of human embryos
for the purposes of research which constitutes the subject-matter of a patent
application cannot be separated from the patent itself and the rights attaching to
it.”^50
Concerning the third question, the CJEU, unfortunately, opted for the wide
interpretation of the concept of “uses of human embryos.” To be precise, the
CJEU considered that this concept excludes the patentability of inventions, if
their technical teaching, which follows from the patent application, implies previ-
ous destruction of human embryos or their use as base material, regardless of the
stage in which this occurs and even if the description of the technical teaching for
which protection is claimed does not refer to the use of human embryos.^51 The
Court held that it is not important if the destruction of an embryo occurs at a stage
long before the implementation of the invention, as in the case of the production of
embryonic stem cells from a lineage of stem cells.^52 According to the Court, if this
were not to be taken into account, then the provision of Article 6 paragraph 2 item
(c) would be redundant since a patent applicant could avoid its application by
skillful drafting of the claim.^53 Incidentally, the decision quite incorrectly states
that this position of the Court is identical to the one of EPO’s Enlarged Board of
Appeal in case G 0002/06 (Stem Cells/WARF).^54 The CJEU probably misunder-
stood the Stem Cells/WARF decision because the reasoning of the Enlarged Board
of Appeal in Stem Cells/WARF clearly reflected the intermediate interpretation of
Rule 28(c) of the European Patents Implementing Regulations to the Convention on


(^48) See Article 5 of the Directive and recitals 16 and 38 of the Directive.
(^49) See, e.g., EGE ( 2002 ), p. 13.
(^50) See CJEU ( 2011 ), para. 43.
(^51) See CJEU ( 2011 ), para. 52.
(^52) See CJEU ( 2011 ), para. 49.
(^53) See CJEU ( 2011 ), para. 50.
(^54) See EBA ( 2008 ), paras 2–11.
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 73

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