Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

Patentability of human embryonic stem cell inventions also depends on the
answer to the third question—what is the reach of the wording “uses of human
embryos?” There are several possible interpretations. According to the first, wide
interpretation, this wording would negatively affect the patentability of the follow-
ing: (1) patent claims in which any use of an embryo is mentioned, related to either
products or processes; (2) patent claims related to products, in which a use of an
embryo is not mentioned, but the use of an embryo is part of the technical teaching
of the invention, which is part of the patent application and is necessary to work the
invention; (3) patent claims related to products, in which a use of an embryo is not
mentioned and the use of an embryo is not part of the technical teaching necessary
to work the invention, but its part is a product for the production of which it was
necessary to use an embryo in some of the earlier stages of the technology
development; and (4) patent claims related to processes in which the products
mentioned in (2) and (3) are used or produced. In other words, the wide interpre-
tation would cover not only the case when an embryo is directly used in every
working of the invention but also any product obtained with the help of an embryo
and the process in which that product is used as a starting material, regardless of
whether embryo use was just one of the steps in the emergence of the technology
preceding the invention, which does not have to be repeated, and regardless of what
is claimed in the patent claims. If this interpretation would be accepted,
nonmodified embryonic stem cells, embryonic stem cell lines, cells resulting
from embryonic stem cell differentiation, and genetically modified embryonic
stem cells and similar,i.e., all products and processes utilizing the technologies,
in the development of which it was at least once necessary to use an embryo, would
be unpatentable because they would be considered uses of human embryos
according to Article 6 paragraph 2 item (c) of the Directive.
Conversely, this wording can be interpreted narrowly so as to include only cases
when a use of an embryo is explicitly mentioned in the patent claims. If we applied
this interpretation, cases under (1) would be unpatentable, that is, a patent would not
be granted only if patent claims explicitly mentioned any use of an embryo.
Therefore, methods of isolating embryonic stem cells from embryos would be
excluded from patentability even by this interpretation,^43 as well as embryonic
stem cells isolated from an embryo, if the isolation is mentioned in the patent
claims. On the other hand, patents would be granted in cases in which patent claims
would not mention the use of embryos, but the use of embryos would follow from
the patent application or if it would be obvious from the state of the art that an
embryo has to be used for working the invention. A patent would, for instance, be
granted in cases when patent claims sought the protection of embryonic stem cells,
not mentioning the method by which they are obtained. It would not be relevant if,
for example, the patent application stated that embryonic stem cells encompassed
by the patent claims are obtained by isolation from embryos,i.e., by embryo use. In


(^43) This was also the position of the United Kingdom Patent Office before the CJEU’s decision in
Oliver Br€ustle and the EPO’s decision in G 02/06. See Porter et al. ( 2006 ), p. 654.
68 J. Mutabžija

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