Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

the goal of benefiting that embryo, there is no use of the embryo because it is not
exploited. In other words, an embryo is not a means to an end, but it is the end. If the
intention of the European legislator was to ensure patentability only of those latter
inventions, then it was not necessary to add any qualification to Article 6 paragraph
2 item (c) of the Directive, let alone the qualification “for industrial or commercial
purposes.” It would be more than sufficient if the text of the provision read “uses of
human embryos” and recital 42 of the Directive emphasized the patentability of
inventions useful to embryos.
Now, due to the current wording of the provision, two problems arise. First, the
wording implies that the application of therapeutic and diagnostic inventions on an
embryo, which are beneficial for it, represents a nonindustrial or a noncommercial
use of an embryo. However, even if we could consider that those inventions entail
uses of an embryo, the uses are certainly not nonindustrial or noncommercial. These
procedures could, logically, also be commercialized as any other therapeutic and
diagnostic procedures generating large profits for the players in the so-called health
industry. The second problem arising from such a solution of the European legis-
lator is the fact that it is not clear whether this is the only “exception to an
exception” or there are more. Namely, by reading the said provision, one could
conclude that there are other nonindustrial and noncommercial uses of an embryo
that are patentable. For example, are embryo uses in scientific research
nonindustrial or noncommercial? It is difficult to find a reason for which someone
would want a monopoly on scientific research, which would be the result of the
possible patent grant, if that reason is not the development and further exploitation
of commercial products. Someone who just wants to advance science or gain glory
for his/her scientific achievements could simply publish the results of the research
not seeking to monopolize them. Even if the patent holder really had only noble
intentions when the patent application was submitted, it is crucial that patent law
does not provide for a limitation of the use of the invention when granting patents,
so their holder can use the inventions for any purpose allowed by law, including
those industrial or commercial. Nothing is preventing him to change his mind and to
start using the results of his research within the duration of the monopoly for
commercial or industrial purposes. Therefore, the only right answer to the question
is their another “exception to the exception” in relation to the provision of Article
6 paragraph 2 item (c), in addition to the one mentioned in recital 42, has to be
negative, even though this makes the qualification “for industrial or commercial
purposes” obsolete and irrelevant.
The second question that has to be answered concerning Article 6 paragraph
2 item (c) of the Directive was already posed in the previous sections—what does
the term “human embryo” encompass? Does it include only entities created by
fertilization or also those created by somatic cell nuclear transfer, parthenogenesis,
or in any other manner? If the traditional definition would be adopted, the provision
would not cover therapeutic cloning or human embryonic stem cells isolated from
embryos created by processes other than fertilization. They would be patentable
provided they would not be caught by the generalordre publicand morality clause
from paragraph 1 of Article 6.


Embryonic Stem Cell Patents and Personalized Medicine in the European Union 67

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