President

with regards to its practical applicability (no patent has even been refused on
the basis of this clause), and with regards to its general meaning 88 .
It must therefore be taken into account that the concept of public order
and morality implies a complete overhaul of the widespread feeling of the
international community, a feeling that goes beyond the directives of a single
country, as recalled by the Guidelines on biotechnological inventions, which
suggest that “a fair test to apply is to consider whether it is probable that the
public in general would regard the invention as so abhorrent that the grant of
patent rights would be inconceivable” (EU Dir. 98/44/EC.). A trend for the
application of the “ethical clause” can be found in Article 6 second subsection,
which exemplifies a non-exhaustive list of non-patentable inventions: “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”. Also Article
27, paragraph 2, of the Agreement on Trade Related Aspects of Intellectual
Property Rights (TRIPS 2) authorises individual countries to exclude the
patentability of inventions that are in contrast with “order public or morality,
including to protect human, animal or plant life or health or to avoid serious
prejudice to the environment, provided that such exclusion is not made merely
because the exploitation is prohibited by their law”.
Chimeras and hybrids are not openly mentioned, but “Consideration”
number 38 of the EC Directive, clarifying the scope of Article 6, explicitly states
that the list has a merely indicative character for the purpose of interpreting the
reference to public order or morality and significantly adds that “whereas
processes, the use of which offend against human dignity, such as processes
to produce chimeras from germ cells or totipotent cells of humans and animals,
are obviously also excluded from patentability”. This principle is stresses by the
Guidelines for Examination in the European Patent Office (December 2007):
“Also excluded from patentability under Art. 53(a) are processes to produce
chimeras from germ cells or totipotent cells of humans and animals (EU Dir.
98/44/EC, rec. 38)”.
We could conclude that the creation of chimeras and hybrids is contrary,
beyond the cloning techniques adopted and the embryo’s legal status, to the
general clause of respect for ordre public and morality. However, in the
interpretative processes, the boundary between biological sequences easily
assimilated to any chemical reaction and human biological sequences which
imply protection of dignity profiles, is still uncertain, as recalled in the
Commission Report to the European Council and Parliament on the
“Developments and implication of patenting laws in the biotechnology sector”
(COM/2005-312). Generally, there’s no lack of interpretations that assimilate
chimeras and hybrids, obtained with any genetic material, to mere “interspecies
entity” biological artefacts or “Human/Non-human Interspecifics”. An
Australian society, Amrad, in 1999 obtained a patent that covered the
production of embryos containing human cells and cat, sheep, pig, bovine, goat
or fish cells 89 . Edinburgh university had originally obtained a patent (EP number
88 D. Neri, Etica e brevetti: il caso delle cellule staminali umane, “Bioetica”, 2008, 2, pp. 203 ff.
89 Subsequently, a provider of some of the base materials in the Chinese technological
development was sold to an American society, Chimicon international.
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