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.
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