Patentability of Inventions Related to Human Embryonic Stem Cells
|Position:||Adviser to the Civil Chamber, Supreme Court of Estonia|
1. Introduction - 2. Legal framework - 3. The definition of ‘embryo’ - 4. Pluripotent stem cells - 5. The uses of human embryos for industrial or commercial purposes - 6. Ordre public and morality exclusion - 7. Conclusions
Adviser to the Civil Chamber
Supreme Court of Estonia
Patentability of Inventions
Related to Human Embryonic
Imagine the case where it is possible to treat patients who have suffered a spinal cord injury by using human
embryonic stem cell*1 (hereinafter referred to as the hESC) therapy. At ﬁ rst glance, this might seem impossi-
ble, but Geron Corporation has already initiated a clinical trial of hESC-derived oligodendrocyte progenitor
cells. At that time, in 2010, Geron’s president, Thomas B. Okarma, considered this clinical trial a milestone
for the ﬁ eld of hESC-based therapies.*2 Embryonic stem cells are stem cells derived from the blastocyst
stage of the embryo (5–7-day embryo).*3 These stem cells are pluripotent; that is, they have the capacity to
develop into any of the 200 cell types that make up the human body*4 and can proliferate in the laboratory
(in vitro) indeﬁ nitely.*5 It is hoped that, because of the properties stem cells possess, it will become pos-
sible to use them in therapy for degenerative diseases or injuries*6, to use them to replace whole cells, and
to manipulate them to regenerate defective tissues or organs and cause them to grow back.*7 Clearly, the
potential beneﬁ t for mankind from hESCs cannot be underestimated. Still, hESC research, especially the
patentability of inventions pertaining to hESCs, has created heated debate in Europe. One reason for this is
that, for obtaining the hESCs from the blastocyst stage of the embryo, the embryo is usually destroyed.*8
1 A stem cell is a precursor cell that gives rise to specialised cells of various types as well as to more stem cells. It is an undiffer-
entiated cell that can divide without limit and whose progeny includes both further stem cells or cells destined to differentiate.
See D. P. Clark, N. J. Pazdernik. Biotechnology: Applying the Genetic Revolution. Amsterdam etc.: Elsevier/Academic Press
2009, p. 733; G. Van Overwalle. European Commission, European Group on Ethics in Science and New Technologies to the
European Commission. Study on the patenting of inventions related to human stem cell research, 30.12.2001. Luxembourg
2002, p. 8.
2 Geron Initiates Clinical Trial of Human Embryonic Stem Cell-Based Therapy. Available at http://www.geron.com/media/
3 D. P. Clark, N. J. Pazdernik (Note 1), p. 709.
4 G. Laurie. Patenting Stem Cells of Human Origin. – European Intellectual Property Review 2004 (26) 2, p. 60.
5 G. Van Overwalle (Note 1), p. 8.
6 European Group on Ethics in sciences and new technologies to the European Commission. Opinion on ethical aspects of
patenting inventions involving human stem cells. Opinion No. 16, 7 May 2002. Luxembourg 2002, p. 5.
7 D. P. Clark, N. J. Pazdernik (Note 1), p. 488.
8 M. Eder-Rieder. Aspekte der Stammzellentechnologie im Besonderen in Großbritannien, Deutschland, Österreich und
der Schweiz. – ZfEV 2007/4, p. 18; J. A. Johnson et al. Stemm Cell Research – CRS Report for Congress. – Practicing Law
Institute. Patents, Copyrights, Trademarks, and Literary Property Course Handbook Series, September 2005, p. 359. (840
94 JURIDICA INTERNATIONAL XVIII/2011
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