illnesses compared to chemicals frequently used by the pharmaceutical industry.
Regarding the development of personalized medicine, huge leaps forward were
made in the last 15 years or so, following the successful isolation of human
embryonic stem cells. What also followed, however, was an endless and often
tiresome debate on the moral and ethical (un)acceptability of possible treatments
involving those cells, which poured over to the legal arena. The controversy is
fueled by the fact that the primary source of human embryonic stem cells is a human
embryo, an entity that, according to most, deserves special treatment, if not for
anything else then for being a stage in the development of a human being.
While the actual ethical arguments pro and con the application of human
embryonic stem cells in medical treatments are not discussed here, the main
objective of this chapter is to determine the effect the debate, which is a direct
consequence of different religious, philosophical, and ethical beliefs throughout
Europe, has had on the possibility to patent the technology revolving around human
embryonic stem cells on the territory of the European Union. To enable the reader
to more easily follow the discussion on patentability, a short overview of the basic
science of embryonic stem cells and their potential in medicine, as well as an
overview of the legality of stem cell research in the European Union, is firstly given
as a background. After that, EU legislation related to the patentability of stem cells
and its application in practice is comprehensively analyzed.
2 The Basic Science of Embryonic Stem Cells and Their
Potential in Medicine
Embryonic stem cells are cells that are unspecialized but have the ability to develop
into all cell types found in a developed human body, if exposed to the right
conditions and signals. In addition to this trait, unlike adult stem cells, which can
be found in very small quantities in the developed human body, which are mainly
thought to be able to differentiate into a few types of cells and which have a limited
self-renewal abilityin vitro, embryonic stem cells are thought to be practically
immortal. In other words, they have shown thein vitroability to proliferate—or
continuously divide—indefinitely, resulting in millions of stem cells. Importantly,
once a stem cell line is established, there is no further need to use an embryo as base
material for research—the cells from the established cell line can be used instead.
An embryonic stem cell is thought to be pluripotent, meaning they can develop into
any cell or tissue of the human body but are incapable of developing into a full
human being. Only the zygote—the fertilized human ova—and the first eight cells
created in the division of the zygote are thought to be totipotent or capable of
developing into a full human being.^1
(^1) For more information on the basic science of embryonic stem cells and stem cells in general see
e.g. DHHS ( 2001 ), NA ( 2006 ), and NIH ( 2009 ).
54 J. Mutabžija