Demarcation of the concepts ‘invention’ and ‘discovery’ in the context of legal protection of genetic engineering developments

The role biotechnologies play both in modern economy and social life is on the rise. Adequate legal regulation of the research and business activity in the sphere accordingly become sincreasingly important. Rapid development of genetic engineering results not only in new scientific problems but also in urgent need to answer questions both of ethical and legal nature. Legal aspects of the topic are exactly the subject of the report presented for the discussion at the round table. The classification of legal norms limiting research in genetic engineering based on the object of the restriction is given: the first group is presented by the norms, prohibiting the precise type of research activity, the second – by restrictions on the patenting of some scientific results. Norms limiting the scope of the objects that are considered patentable also fall into two categories: the introduction of the first category is stipulated by the necessity of the compliance with the principles of morality and humanity in the course of the research process, adoption of the second category ensures the freedom of research that presumes the absence of any restrictions on the use of theoretical knowledge. The latter aim can be achieved only if there is a clear demarcation between the terms “invention” and “discovery” in the patent law, along with the absence of the opportunity to acquire property rights to such a result of intellectual activity as scientific discovery. Analysis of law-enforcement practice, however, shows that in case of the developments of genetic engineering this demarcation line is often blurred. In particular, it results in patenting human genes and their sequences. The report deals with the historical and legal aspects of the phenomenon, foreign jurisprudence is analyzed, the necessity of international regulation in the sphere is formulated.