This provision could also cause problems in relation to the patent eligibility of
embryonic stem cells in light of claims made by some scientists that stem cells
could be conditioned to become totipotent in the laboratory.^23 Taking into account
that until now, to the best of the author’s knowledge, no studies were published that
would actually prove the totipotency of human embryonic stem cells or that would
undoubtedly prove such differentiating potential of embryonic stem cells in other
species, from a legal point of view embryonic stem cells could not be considered a
stage in the formation and development of the human body in the sense of Article
5 paragraph 1 of the Directive.
Nevertheless, presuming that embryonic stem cells could satisfy the novelty,
inventive step, and industrial applicability requirements and that theordre public
and morality exception would not apply, one has to ask what to do in case one or
more patents are already granted in relation to inventions involving embryonic stem
cells and it is subsequently proven that they are actually totipotent. Here, two
different situations are possible: first, that totipotency is proven not to be an
intrinsic, natural characteristic of human embryonic stem cell,i.e., that they are
not totipotentper sebut can become totipotent with human intervention on the very
embryonic stem cell, such as the introduction of other elements, their genetic
manipulation, etc., and second, that totipotency is proven to be their intrinsic,
natural trait,i.e., that embryonic stem cells will show totipotency if exposed to
appropriate external conditions, without making modifications to the embryonic
stem cell itself.
In the first case, only modified embryonic stem cells would be totipotent and
would represent a stage in the formation and development of the human body in the
sense of Article 5 paragraph 1 of the Directive. On the other hand, nonmodified
embryonic stem cells would not be totipotent, and the provision would have no
effect on them. In other words, they could continue to constitute patentable inven-
tions.^24 Considering such possible outcome, it would be advisable to demand from
patent applicants to include a disclaimer in their patent applications so that protec-
tion is sought only for nontotipotent embryonic stem cells. This solution corre-
sponds to the manner of resolving problems in relation to patenting of natural
products, proposed by Eisenberg.^25 In the second case, embryonic stem cells would
have to be considered a stage in the formation and development of the human body
according to Article 5 paragraph 1 of the Directive. In that case, any granted patent
would have to be declared invalid according to the national laws of states in which
the patent was granted. Of course, this solution is neither simple nor practical
because the invalidating process would have to be conducted subsequently in
(^23) See, e.g., Denker ( 2006 ).
(^24) But see Denker ( 2008 ), who claims that patenting is barred whenever cells have the potential to
renew the embryo even if such potential is shown exclusively with significant human intervention.
However, if that reasoning would be applied, one could also say that the nucleus of every cell in the
body is totipotent since it supports embryo development if transferred to an unfertilized egg cell by
means of somatic cell nucleus transfer.
(^25) See Eisenberg ( 2000 ).
Embryonic Stem Cell Patents and Personalized Medicine in the European Union 61