Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

the Grant of European Patents, which is identical to Article 6 paragraph 2 item
(c) of the Directive.^55
The arguments against adopting the wide interpretation of the provision in
question were already elaborately put forward in one of the previous sections of
this chapter, so they will not be repeated here at length. It suffices only to reiterate
that the CJEU’s interpretation brings the provision into conflict with the general
ordre publicand morality clause, which blocks the patentability only of those
inventions, the commercial exploitation of which is in breach of public order and
morality. Something that occurred in the phase of research, long before the com-
mercial exploitation of an invention takes place, is clearly outside of the scope of
the exception. Nevertheless, the CJEU thought otherwise. The practical implica-
tions of its decision entail a severe blow to the scientists and companies operating in
the human biotechnology field in the European Union since the decision practically
outlawed the patenting of almost all inventions involving human embryonic stem
cells, including those related to therapeutic cloning. The worries of the human
biotechnology sector were confirmed when the EPO amended its Examination
Guidelines to include to CJEU’s conclusions and started to reject patent claims
that would have most likely been granted under the EPO’s approach following the
Enlarged Board of Appeal decision in Stem Cells/WARF.^56


4.2.2 CJEU Decision in International Stem Cell Corporation


The second referral to the CJEU regarding the interpretation of the same provision
of the Directive came in April 2013 from the High Court of Justice (England &
Wales), Chancery Division (Patents Court), in case no. [2013] EWHC 807 (Ch),
International Stem Cell Corporation v Comptroller General of Patents. International
Stem Cell Corporation (hereinafter: ISCC) filed two patent applications with the
UK Intellectual Property Office claiming methods of producing pluripotent human
stem cell lines from parthenogenetically activated oocytes and stem cell lines
produced according to the claimed methods and methods of producing synthetic
cornea or corneal tissue, which involve the isolation of pluripotent stem cells from
parthenogenetically activated oocytes and product-by-process claims to synthetic
cornea or corneal tissue produced by these methods.^57 The Hearing Officer, acting
for the Comptroller, applied the reasoning from the Oliver Br€ustle case and refused
to grant patents because the applications concerned parthenotes,i.e., unfertilized
human ova whose division and further development were stimulated by partheno-
genesis.^58 These were, according to the CJEU, considered embryos, and due to this,
the applications in question related to “uses of human embryos for industrial or


(^55) See Mutabžija ( 2014 ), pp. 150–157.
(^56) See Mutabžija ( 2014 ), pp. 145–164. See also Minssen and Nordberg ( 2015 ).
(^57) See CJEU ( 2014 ), para. 10.
(^58) See CJEU ( 2014 ), paras 11 and 12.
74 J. Mutabžija

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