4.1.2 Processes for Cloning Human Beings and Uses of Human
Embryos for Industrial and Commercial Purposes
As an addition to the generalordre publicand morality clause laid down in Article
6 paragraph 1 of the Directive, which prevents the patenting of inventions if their
commercial exploitation is contrary toordre publicand morality, Article 6 para-
graph 2 prescribes that the following, in particular, shall not be patentable on the
basis of paragraph 1:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them
suffering without any substantial medical benefit to man or animal, and also animals
resulting from such processes.
This paragraph provides an illustrative, nonexhaustive list of inventions, which
are considered contrary toordre publicand morality and, thus, unpatentable. If an
invention can be classified as belonging to one of these four categories, the grant of
the patent for such an invention mustipso factobe refused. However, if an
invention cannot be thus classified, it must not be automatically presumed that it
is patentable, but one also has to consider whether the generalordre publicand
morality clause could prevent patentability. Hereinafter, particular focus will be
given to analyzing items (a) and (c) on the list since they are particularly significant
for the patentability of human embryonic stem cells.
The first category of inventions contrary toordre publicand morality on the list
is processes for cloning human beings. Recital 41 of the Directive defines the
process for cloning human beings “as any process, including techniques of embryo
splitting, designed to create a human being with the same nuclear genetic informa-
tion as another living or deceased human being.” This definition of cloning is
substantially the same as the one given in the Protocol. Applying this definition
in the interpretation of Article 6 paragraph 2 item (a) of the Directive, it can be
concluded that processes for reproductive cloning of human beings, or cloning with
the objective of creating a functional human being, are excluded from patentability.
However, the definition does not help in answering the question whether therapeu-
tic cloning is encompassed by the prohibition or not.^35 If it is taken into account that
(^35) Herdegen, for example, is of the opinion that this provision relates exclusively to reproductive
cloning. See Herdegen ( 2002 ), p. 154. However, certain documents related to the history of the
Directive on Patents in Biotechnology point to the conclusion that the intention of its drafters was
to exclude from patentability not only reproductive but also therapeutic cloning. For instance, in
drafting Article 6 paragraph 2 item (a) of the Directive, the formulation “processes for reproduc-
tive cloning of human beings” was replaced with the formulation “processes for cloning human
beings” because the adjective “reproductive” was considered too restrictive. In addition, the
European Group on Ethics in Science and New Technologies to the European Commission
considers the patentability of processes for creating human embryos by cloning with the objective
of isolating stem cells ethically unacceptable and calls for their unpatentability. See Saunders and
Mutabžija ( 2004 ), p. 22.
64 J. Mutabžija