You are here: Home :: Area JESP :: Jurisprudence

Shun-liang Hsu

The Paradox Facing DNA Patenting in Europe

Nowadays there are increasing biological innovations standing in the filing queue to be passed by the authority so that the patentee can claim the trophy of exclusive right awarded by State. On the one hand, this may be seen as a sign that the heavily invested bio-industry is beginning to bear fruits, which according to some famous management school, serves as an important indication to demonstrate how competitive a State is as a whole. Whereas, on the other hand, because the controversy centering biotechnology has long time been the material per se, the access to such material and the potential applications, to apply the current practice in patent system to grant 20 years of exclusive right in exchange of disclosure of key techniques in biology may give rise to certain ethical issues of different fashion than those in other industrial sectors.

DNA, deoxyribonucleic acid consists of four building blocks, termed nucleotides – Adenine (A), Guanine (G), Cytosine (C) and Thymine (T). Usually in the cell nucleus, genes are contained in long DNA molecules and can be represented as letters in a four- letter alphabet used to write out the biological messages. Each cell of the human body maintains information-containing hereditary units, the genes that control identifiable traits of an organism. There are approximately 26,000 to 31,000 protein-encoding genes in the human genome.

In the knowledge-based era, patent provides an excellent vehicle to drive technology further into exploration of the unknown world. Despite any potential risk from upstream scientific R&D to downstream business strategy, government's policy often plays a pivotal role in the whole picture. As a result, political interpretation of a newly developed technology seems to always surpass the appealing benefits envisaged by different interested groups, being academia or industry. The reason why biotech craze can boom within the industry is likely to be attributed to the incentive a rather rigid patent system can provide. In addition to other pre-requisites, to determine whether a biological invention constitutes patentable subject matter, two notions have been raised to argue in practical evaluation. The first one is the substantial difference between discovery and invention and the second, the ethical judgment-whether or not an invention is contrary to ‘order public’ or ‘morality’. In review of the numerous appealing cases, it seems that no explicit criteria have satisfied groups of different interests so to serve as the general reasoning ground for objection parties to demur to a patent.

‘order public’ or ‘morality’ per se are concepts of uncertain nature. The grant of a patent is an act of state sovereignty – or, in the EPO's case, of sovereignty vested in an intergovernmental agency. The purpose of Art.53(a) EPC is to prevent the impression being given that an invention would be exploited to be contrary to legal fundamentals or to offend the sense of decency on any reasonable person bears the seal of state approval. In a lower level, differences of moral standards have already been foreseen under the setting of patent framework before EPC was implemented. What appears more fundamental than the utilitarianism's product-the patent, for example human dignity seems to be a question inappropriate to be subject to any utilitarian's premise for discussion.

Despite any potential drawbacks imposed by ethical deliberation, what seems fast growing nowadays is the piled up applications for gene patent and a still ambiguous principle tangled by vigorous ethical debate.

Journal of International Biotechnology Law, Walter de Gruyter

Print ISSN: 1612-6068
Volume: 3, 03/2006
Pages: 72 - 83

Show full article (external site)

Show all available items of this journal

 

Area JESP