Personalized_Medicine_A_New_Medical_and_Social_Challenge

(Barré) #1

ordre publicand morality clause, inventions are unpatentable if their commercial
exploitation is contrary toordre publicand morality regardless of whether the
patent applicant actually has the intention to commercially exploit the invention or
not, one must ask why Article 6 paragraph 2 item (c) of the Directive contains the
qualification “for industrial or commercial purposes” at all.
In the draft of the Directive from 29 August 1997, this provision did not include
the qualification and it read: “methods in which human embryos are used.”^40
However, almost in the last minute before the Directive was adopted, the text of
Article 6 paragraph 2 item (c) was changed and the provision took its current form,
which excludes only uses of human embryos in industrial or commercial purposes
from patentability. Thetravaux pre ́paratoiresof the Directive reveals that such
amendment was made to enable patenting of inventions whose purpose is thera-
peutic or diagnostic, which are applied on the embryo and are useful for it, and
prevent the patenting of inventions that include the uses of human embryos for
industrial or commercial purposes.^41 Contemporaneously with the amendment to
the text of the provision, a new recital was included in the Directive—recital 42.
The recital defined this “exception from an exception” stating that “in any case such
exclusion does not affect inventions for therapeutic or diagnostic purposes which
are applied to the human embryo and are useful to it.” It seems, however, that such
an amendment, the goal of which was to clarify the scope of Article 6 paragraph
2 item (c) of the Directive, had the opposite effect, complicating the interpretation
of the said provision.
To be exact, it is difficult to see the relevancy of distinguishing between uses of
human embryo for industrial or commercial purposes and therapeutic or diagnostic
inventions applied to the human embryo to cure it or to benefit it in some other way
when the application of these latter inventions to the embryo does not constitute a
use of the embryo.^42 The wording “uses of human embryos” implies the exploita-
tion of an embryo as a means to an end, such as drug testing on human embryos.
Conversely, when applying therapeutic or diagnostic procedures on an embryo with


of patents is to reward inventors and encourage further innovations. This reward and incentive
consist of the monopoly that the patent holder will enjoy in relation to the invention for a limited
period of time, in which he can use the invention in any way allowed by law, including commercial
exploitation or generating profits from the invention. All other motives of filing patent applications
claimed by the applicants are not relevant because patent law does not envisage the possibility to
limit the use of an invention in the process of granting a patent, and its holder is allowed to use it
for any purpose that is not prohibited by law, including those industrial or commercial purposes. A
patent holder might truly have the invention to use the patented invention for a noble purpose,
which does not have to be industrial or commercial, but once the patent is granted, patent law has
no means to prevent the patent holder to actually use the invention in industrial or commercial
purposes. That the intention to commercially exploit an invention is necessarily connected with
filing patent claims is also the position of Moufang ( 1994 ), p. 504, and Sterckx and Cockbain
( 2010 ), p. 91. See also CJEU ( 2011 ), para. 41.


(^40) See Porter ( 2010 ), p. 20.
(^41) See Council of the European Union ( 1998 ), para. 37.
(^42) Similarly Torremans ( 2010 ) and Piirman ( 2011 ).
66 J. Mutabžija

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