The European Patent Law and Biotechnology: Ethical, Legal and Economic Aspects of Human Genes Patentability

Abstract: This thesis analyses the debate around the patents on human genes from three most important angles: ethical, legal and economic. In the ethical context, patents on gene-related inventions are often seen as inappropriate because of the alleged special status of human DNA. The special status stems from their alleged responsibility for everything from diseases to social propensities and personal traits. If so, patents could be seen as ethically undesirable because they would grant monopoly power over the very determinant of humanness. Yet, despite the fascination of the scientific community with DNA, the special status does not find any foundation in science. The formation of either a disease or personal traits is not determined solely by genes but rather by a complex interplay between different participants of cell reproduction process and the environment. Therefore, since DNA seems not to have any special status, patent protection cannot be denied because of the violation of it. Ethics provide also an additional argument on the basis of which patents could be rejected: the threat of commodification or even enslavement of people. Genes occur in each and every individual, therefore they should belong to everybody constituting the common heritage of mankind. Patents however grant monopoly rights (understood often as ownership rights) over the protected inventions. It implies that these exclusivity rights are granted to a single person or entity entailing in the popular understanding the restrictions on the use or right to dispose over one's own body by all the other individuals. This has been often perceived as a form of a contemporary enslavement. This logic however overlooks one important element: patent protection has not been granted on the genes being still a part of human body but their isolated and substantially modified copies. Therefore, patents cannot entail enslavement of people because they do not apply to their own body parts. The other argument advanced by the patent-opposing voices posits that patents lead to commodification of people. Patents apply market rhetoric to the objects they protect thereby subordinating human genes to market terms or market exchange. The major concern is here that the perception of some body parts (i.e., genes) as a marketable good will expands to cover the entire human. Interestingly, such concerns are not voiced in relation to other body elements such as hormones, blood or bone marrow, which are similarly researched on and often rendered into patentable inventions. Therefore, the unease about the commodificating consequences of particularly patents on human genes is to be traced back to the special meaning ascribed to them. However, since the special status-argument does not stand the critics, also the assertion that patents will eventually lead to commodification of people does not seem persuasive. Overall, the only meaning human genes may be ascribes is a symbolic one. But it is not sufficient to justify the denial of patents on gene-related inventions. In the legal context, genes are often seen as a product of nature rather than a patent eligible invention. This view however does not see the differentiation between genes occurring in nature and those, which have been isolated, purified and modified for the purposes of a particular industrial application. This distinction still upholds the dividing line between product of nature and product of human ingenuity: the naturally occurring genes cannot be patented as opposed to those isolated and purified ones. It has to be noted however that genes indeed pose a challenge to the existing patent regime. Therefore, each of the requirements of patentability must be reviewed again to sketch an exact scope, which is to be fulfilled by gene-based inventions. The dividing lines between the patentable and not patentable genetic material appear however still obscure. Also the economic efficiency of the patent protection on gene-based inventions is questionable. Contrary to the expectations standing behind the decision to protect gene-related inventions by patents, the recent developments are frightening: there is an impasse in the research and development process in the biotechnological and pharmaceutical fields reflected by the inability of the industry to conduct post-invention research. The main reason for this impasse is the excessive proliferation of property rights coupled with the grant of too wide patent protection. As a consequence, the downstream research is completely impossible, too expensive or not profitable. It follows that the development of new therapies and pharmaceuticals is not only not promoted by patents but rather impeded by them. What would be the best solution to the current deadlock? Most frequently three ways are proposed: narrower utility requirement, patent pools and compulsory licensing. The last one seems to be the most comprehensive and persuasive.