Embryonic Stem Cell Patents
and Personalized Medicine in the European
Union
Jasmina Mutabžija
Abstract This chapter scrutinizes the legal framework for research and patenting
of inventions involving human embryonic stem cells in the European Union.
Particular attention is given to the analysis of the relevant provisions of the
Directive on Patents in Biotechnology and the two cases in which questions were
referred to the CJEU, concerning provisions of the Directive that affect the patent-
ability of human embryonic stem cell inventions. The close examination of Article
6 paragraph 2 items (a) and (c) reveals that the biggest problems in the uniform
application of the provisions contained therein are caused by the lack of definitions
of some very important terms and concepts, such as “human embryo” and “uses of
human embryos.” It is suggested that it is not legally correct to define embryos as to
include organisms created by somatic cell nuclear transfer and parthenogenesis for
the purposes of the Directive because these organisms cannot complete the devel-
opment of a human being, and the embryo is protected by the Directive primarily as
an entity that has the capability to complete this process. Furthermore, it is put
forward that the concept “uses of human embryo” should not encompass uses of
human embryos in the stage of research, but it should prevent patentability only if
human embryos are used when working the invention. Any wider interpretation
would be in conflict with the wording of the generalordre publicand morality
clause from Article 6 paragraph 1 of the Directive.
1 Introduction
Even though the use of human biotechnology is extremely promising for the
development and advancement of personalized medicine, it is equally controversial
since elements of the human body are used in medical treatments and products to be
applied in those treatments. On the other hand, however, one could, among other
things, argue that human biotechnology enables a more natural way of treating
Jasmina Mutabžija Ph.D., LL.M.; PAR Business School, Rijeka, Croatia.
J. Mutabžija, Ph.D., LL.M. (*)
PAR Business School, Rijeka, Croatia
e-mail:[email protected]
©Springer International Publishing Switzerland 2016
N. Bodiroga-Vukobrat et al. (eds.),Personalized Medicine,Europeanization and
Globalization 2, DOI 10.1007/978-3-319-39349-0_4
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