Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

other words, such narrow interpretation would enable the patentability of the
aforementioned cases under (2), (3), and (4) provided that patentability would not
be barred by the generalordre publicand morality clause from Article 6 paragraph
1 of the Directive.
The third option would be a compromise between the wide and the narrow
interpretations, according to which the “uses of human embryos” would exclude
patentability in cases in which embryo use is mentioned either in patent claims or as
part of the technical teaching described in the patent application. Under this
intermediate interpretation, Article 6 paragraph 2 item (c) of the Directive would
prevent the patenting of the aforementioned cases under (1) and (2), whereas the
cases under (3) and (4) would be patentable. For instance, an invention concerning
the method of culturing or preserving embryonic stem cells would be patentable.
Patents could be granted even if patent claims mentioned embryonic stem cells as
products, provided that uses of embryos are not mentioned in the patent claims or in
the patent application, and provided that the patent claim was submitted at the time
when the state of the art was such that destroying embryos was not the only manner
of obtaining embryonic stem cells, and they could be obtained, for instance, from
already formed embryonic stem cell lines.
Answering the question which one of these three interpretations would be best, it
seems that the application of the wide interpretation is the least advisable, if not
even completely wrong. This is primarily due to it not being in accordance with the
generalordre publicand morality clause. To be precise, the items on list in
paragraph 2 of Article 6 were intended to be examples of inventions that should
be considered contrary toordre publicand morality according to paragraph 1 of the
same article. It is obvious from the wording of the provision, and also from recital
38 of the Directive, that the list is merely an exemplary explanation and an
illustrative specification of the generalordre publicand morality clause. From
this, it logically follows that the provision cannot be interpreted in the way that
would bring it into collision with that general clause. Adopting the wide interpre-
tation would result exactly in such disparity between the specific and the general
clauses since the wide interpretation mostly pertains to actions that happened long
before the commercial exploitation of an invention, in the stage of research and
development of not only the specific invention but also of the entire technology
preceding it, whereas Article 6 paragraph 1 of the Directive prescribes that only
actions classified as commercial exploitation have to be taken into account.
Although an embryo could have been really used in the development of the
invention in a particular case or the embryonic stem cell line that is the source
material for the invention could have been initially derived from an embryo, the fact
remains that the invention itself and its working do not have to include the use of
human embryos. This means that the invention cannot be embraced by Article
6 paragraph 2 item (c) of the Directive. The wide interpretation would lead to
unwanted consequences because it would introduce even more uncertainties into
the already complex provision of Article 6 paragraph 1 of the Directive. In addition,
this would be contrary to the principle that is deeply rooted in the European patent
laws, especially the European Patent Convention, that the exceptions to


Embryonic Stem Cell Patents and Personalized Medicine in the European Union 69

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