Personalized_Medicine_A_New_Medical_and_Social_Challenge

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not inherently, without genetic manipulation, capable of developing into a human
being?
It must also be emphasized that the EU member states still have the discretion to
block patentability of inventions involving parthenotes under the generalordre
publicand morality clause. The patentability of these inventions is now solely in the
realm of each member state’s cultural norms, which means that there will most
likely be large differences in the treatment of the same inventions throughout the
European Union.


5 Conclusion


The biotechnology industry is one of the crucial fields for the development of
personalized medicine. However, the field is subject to constant changes and
developments due to which patent protection can be of utmost importance for
maximizing the benefits from innovations. Patents are generally considered to
stimulate scientific development and research due to the fact that they enable patent
holders to, in many ways, monopolize the technology to which a patent pertains,
thus enabling easier return on R&D investments. The commercialization of those
valuable innovative ideas is often the result of many years of research, develop-
ment, and enormous financial investments. Without patent protection, unscrupulous
competitors could unfairly exploit the technology relatively easily without proper
authorization.
Considering the significant advances in the field of human biotechnology in the
last decades, which are primarily a consequence of the successful isolation of
human embryonic stem cells and research in somatic cell nuclear transfer and
parthenogenesis with the goal of creating human embryonic stem cells with specific
genetic traits, the creation of tissues and organs for transplantation and specific
personalized treatment of life-threatening illnesses is not far from becoming a
reality. However, for that to happen as soon as possible, it is necessary not only
to clearly regulate the research related to human embryonic stem cells but also to
clearly define all the criteria that have to be met in order to be granted a patent for
inventions involving human embryonic stem cells. This has to be done on the level
of the European Union in both cases, regardless of differing social norms through-
out the EU, since the situation, in which research regarding a particular subject
matter is permitted in some EU member states and even financed on the level of the
European Union, but patentability of the same subject matter is blocked by the
Directive on Patents in Biotechnology, is utterly unacceptable if the goal is to have
an effective European legal framework for innovation and for marketing the
innovations.
It seems that the Directive failed to achieve its goals since instead of maintaining
and encouraging investment in the field of human biotechnology, it effectively
discouraged it in relation to one of its most crucial sectors. Furthermore, the
Directive proved to be too difficult to consistently interpret. It would perhaps be


76 J. Mutabžija

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