4.1 Legal Analysis of the Relevant Provisions of the Directive
on Patents in Biotechnology
The Directive on Patents in Biotechnology contains two articles that are directly
related to the issue of patentability of inventions involving human embryonic stem
cells. Article 5 regulates the patentability of the human body in various stages of its
form and development and the patentability of elements of human origin. However,
due to the fact that embryos are or have been used at one point or another in human
embryonic stem cell research, perhaps the most significant provisions for the issue
of patentability of the results of such research are laid down in Article 6, which
embodies theordre publicand morality exception to patentability. Paragraph 2 of
the said Article is of particular importance since it contains a list of objects that are
expressly excluded from patentability as contrary toordre publicand morality,
including processes for cloning human beings and uses of human embryos for
industrial and commercial purposes.
4.1.1 Human Body and Its Elements
Article 5 paragraph 1 of the Directive on Patents in Biotechnology is very important
for patent eligibility of human embryonic stem cells because it,inter alia, pre-
scribes that the “human body, at the various stages of its formation and develop-
ment” cannot constitute a patentable invention. Although it can be argued that the
exclusion of the human body from patentability is based on ethical reasons,^21 the
basic function of this provision concerns the problem of differentiating between
inventions and discoveries, which also follows from its position in the Directive.
Even germ cells before fertilization are considered a stage of formation and
development of the human body according to the Directive.^22 This provision affects
the possibility to patent totipotent stem cells, since they are capable of developing
into a fully functional human being, so it can be said that they represent one of the
stages in the formation and development of the human body. Therefore, as such,
they cannot constitute inventions. This provision would prevent patenting a single-
cell fertilized egg, which is called a zygote, and the first eight cells created by the
division of the zygote, since each of those cells could lead to a formation of a human
being if implanted into a womb, or if its development is otherwise stimulated.
(^21) This could be concluded from recital 16 of the Directive on Patents in Biotechnology, which
reads: “Whereas patent law must be applied so as to respect the fundamental principles
safeguarding the dignity and integrity of the person; whereas it is important to assert the principle
that the human body, at any stage in its formation or development, including germ cells [...]
cannot be patented.”
(^22) See recital 16 of the Directive on Patents in Biotechnology: “Whereas it is important to assert the
principle that the human body, at any stage in its formation or development, including germ cells
[...] cannot be patented.”
60 J. Mutabžija