Biotechnologies and intellectual property : some aspects of the relationship between the two of them
Publié le 18/11/2008 par Anthony Bochon
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.