they only have to be isolated from an embryo, which is a stage of formation and
development of the human body, to be considered inventions and not discoveries.
Their structure and/or function can remain exactly the same as the one they have in
an embryo. The same applies to other types of stem cells. However, what about
cells that are, according to the current state of the art, truly totipotent, such as the
zygote and the first eight cells created by its division? Even though patent theorists
in principle agree that they cannot enjoy patent protection according to Article
5 paragraph 1,^31 there is a view that totipotency should not be limiting in relation to
their patentability because if they are isolated, they simultaneously satisfy the
requirements from Article 5 paragraph 2 of the Directive.^32 According to such
interpretation, totipotent cells are at the same time a stage in development of the
human body in the sense of Article 5 paragraph 1 of the Directive and an element of
the human body in the sense of Article 5 paragraph 2 of the Directive. There are
many reasons to disagree with such argumentation. First, linguistically speaking,
paragraph 1 definitely prevails over paragraph 2. Namely, the wording of paragraph
1 conveys an absolute prohibition of patenting of the human body in various stages
of formation and development,^33 while paragraph 2 only speaks about the possi-
bility but not about the certain patentability of elements isolated from the human
body or otherwise produced by a technical process.^34 Furthermore, paragraph 1 was
laid down in Article 5 as a basic rule, which is suggested by the fact that it is placed
first in the Article, whereas paragraph 2 represents a qualification of the concept
“simple discovery” from paragraph 1. Finally, if totipotent cells would be consid-
ered patentable, then what would be the purpose and the objective of paragraph 1?
By applying the same logic, one could then claim that germ cells, embryos, or
fetuses, which also represent stages of formation and development of the human
body, are also patentable inventions since they can be isolated from their natural
environment. Isolation or production by means of a technical process does not
change the fact that totipotent cells, as well as germ cells, embryos, and fetuses are
stages of formation and development of the human body according to Article
5 paragraph 1, so paragraph 2 of this Article is inapplicable to them.
(^31) See, e.g., Denker ( 2008 ).
(^32) See Triller Vrtovec and Vrtovec Vrtovec ( 2007 ). Similarly also Webber ( 2005 ), pp. 242–243.
(^33) See the last part of the sentence in Article 5 paragraph 1 in the English language: “cannot
constitute patentable inventions,“ in the French language: “ne peuvent constituer des inventions
brevetables,” and in the German language: “k€onnen keine patentierbaren Erfindungen darstellen.”
(^34) See the last part of the sentence in Article 5 paragraph 2 in the English language: “may constitute
a patentable invention,” in the French language: “peut constituer une invention brevetable,” and in
the German language: “kann eine patentierbare Erfindung sein.”
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 63