Brussels, Belgium
November 19, 2008
Source:
Droit & Technologies
- Portail du Droit des Nouvelles Technologies
www.droit-technologie.org/actuality-1172/biotechnologies-and-intellectual-property-some-aspects-of-a-the-rela.html
Republished with
authorization from Droit & Technologies
Biotechnologies and intellectual
property : some aspects of a the relationship between the two of
them
By Anthony Bochon, Etudiant
(FUSL-ULB)
Intellectual property has
developed a keen interest on biotechnologies for more than two
decades. The implementation of the 98/44 EC directive concerning
the legal protection of the biotechnological inventions confirms
this increasing relationship between science and law. The
content of this article is aimed to define biotechnologies, the
necessity of patent protection for biotechnologies and the legal
hurdles to that protection. This article was part of an essay on
the directive 98/44 EC for the IP course attended during the 3rd
bachelor year of the author at the Facultés Universitaires
Saint-Louis (Brussels).
A. What
Is A Biotechnology?
An essential step in order to understand the scientific area
involved in the specific patenting discussed here is to define
the word “biotechnology”. The realm of the biotechnologies is
constantly extending and concerns various activities . Under the
word “biotechnology” or “biotechnologies”, several sciences and
techniques are covered, which use living organisms, cells, part
of cells and molecules in order to create or contribute to the
production of a product or a service .
The sciences that can be
involved in these processes are microbiology, biochemistry,
genetics and process technology which all contribute to the
scientific research on living material, its components and their
characteristics.
Biotechnologies exist, in the
strict and primary sense of the word, since the Antiquity. The
production of wine or beer – resulting from bacteria and yeast
fermentation – cheese – resulting from an alteration by bacteria
caused to a milk-based product – or bread – which becomes light
and bigger thanks to the yeast – are classical biotechnologies .
They use living organisms for the production of a product.
Modern biotechnologies have the characteristics to work,
directly, on the DNA, that is to say the deoxyribonucleic acid
which contains all the genetic information of a living organism
. Two main technologies appear in the biotechnologies’ world.
The first one is recombinant DNA technology consisting of
genetic manipulations which can be used for the production of
proteines, the development of transgenic plants or animals and
gene therapy – i.e. an attempt to repair dead cells of a patient
by replacing defective genes by normal ones. The second one is
cell fusion, particularly useful for the production of
monoclonal antibodies and for breeding new plants.
Biotechnologies are used as
well for medicine or pharmaceutical purposes as for agricultural
purposes – even for military purposes with biological weapons.
The production of new vaccines is certainly emblematic of the
development of modern biotechnologies since DNA researchers are
trying to find a vaccine against AIDS .
B. Discussing the Necessity of Patent
Protection for Biotechnological Inventions
Ethical questions arise when comes the idea that living
materials can be patentable, especially the human bodies,
precisely its part, its components, even if there are cells or
DNA sequences . On this point, there is a certain cultural
difference between Europe and the USA, which are less reluctant
towards the idea that genes, for example, are patentable.
The genesis of the directive
clearly shows the ethical challenge linked to the directive.
From 1988, when the Commission submitted a proposal for a
Council directive to the 1995 proposal which would be adopted in
1998, the European Parliament intervened in the procedure, this
subject appearing to be highly sensible from a political point
of view . Certain directive provisions remain controversial –
the sections C of this chapter the further developments in
chapters two and three clearly illustrate this.
The necessity of patent
protection, besides the ethical debate, can be assumed if the
competitive aspect of the research’s world is taken into
account. With the existence of patents granted on
biotechnological inventions, the laboratories are invited to
develop innovations: the costs of research are so high that the
non-existence of exclusive rights – what a patent normally
grants – on an invention can refrain laboratories from taking
risks and invest in new fields of science that haven’t been
explored before. The remuneration that a patent provides when
the invention is commercialized is a way to compensate the costs
of the research that led to the invention . This point of view
has been endorsed by the Commission in order to justify the
necessity of patents on biotechnological inventions.
But the temporary monopoly that
a patent creates is maybe not admissible in the case of
biotechnological inventions which also deal with health
problems. Patents can then be “blocking patents” , which don’t
permit new discoveries if these discoveries can only be done
thanks to a patented biotechnological invention . The existence
of contractual licenses – negotiated between the holder of the
patent right and the laboratory wishing to use the
biotechnological invention patented – or compulsory licenses is
a way to permit further scientific progress .
C. Legal Hurdles: Do Biotechnologies Fall
in the Scope of Intellectual Property ?
The core question about the relationship between intellectual
property law and biotechnologies is whether it is patentable or
not. Indeed, even if the words “biotechnological inventions” are
used, it doesn’t mean, a priori, that biotechnologies can be
considered as inventions under patent law.
A first major bunch of hurdles
comes from the legal instruments forbidding the appropriation of
the human body . These hurdles only concern the patentability of
human body elements, and not the patentability of plants and
animals. The Convention of the Council of Europe on the Human
Rights and the Biomedicine forbids in its article 21 the
commercialization of the human body: the patentability of DNA
sequences, for example, would go against the principle of
non-commercialization. The UNESCO Universal Declaration on the
Human Genome and the Human Rights sets forth that “the human
genome underlies the fundamental unity of all members of the
human family, as well as the recognition of their inherent
dignity and diversity. In a symbolic sense, it is the heritage
of humanity” . This is quite contradictory with the idea that a
gene sequence can be patented, i.e. be subject to an exclusive
right of use, even if it is a temporary monopole. Despite these
legal objections which maybe don’t have a substantial legal
force, the European Council adopted the directive 98/44 EC which
affirms in European positive law the idea that biotechnologies
are patentable too.
A second major bunch of hurdles comes from the patent law
classical definition of patentability. Indeed, it is living
material, preexisting before the patent, which is patented. This
somehow changes the approach towards the classical patentability
requirements which state that in order to be patentable an
invention has to be new, original and susceptible of industrial
application . This question will be largely discussed in chapter
two with the comment of the relevant provisions of the directive
concerning patentability conditions.
Attachment(s):
Belgian
law (April, 25th, 2005) (139 KB)
European directive (98/44) on the legal protection of
biotechnological inventions (69 KB)
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