Legal existentiality of bio-patents is an urgent problem of modern intellectual law-making

Keywords: legal existentiality, intellectual lawmaking, EU law system, transformation, harmonization, biotechnology, uniqueness, specificity, biopatents, incompetence, reservations


This article presents a brief, detailed breakdown of the heterogeneity of definitions of biotechnology, as objects of intellectual property, as well as related processes, in international legal acts of the European Parliament, the Council of the EU and the European Community, an attempt has been made to investigate the legal existentiality of biopatents and to characterize the importance of features of the essence of biotechnology, to substantiate the extreme conditionality of the procedure for patenting biotechnology, taking into account this specificity at the stage of creating a national regulatory framework, laid down in the main national regulations. The approaches of international legal acts regarding the consolidation of the principles of protection and protection of intellectual property rights, in particular, and, above all, on biotechnology, as in the a priority scientific, economic and state - strategic sphere, are partially disclosed and the peculiarities of their implementation in national legislation are defined. The warnings about the possible devastating consequences of the current incompetent approach by domestic legislators to the essence of biotechnology as objects of intellectual property, creation of mechanisms of intellectual lawmaking, given their unique ability to self-reproduce and self-reproduce, are pointed out. However, at the same time, it has been noted so far that there have been significant changes in the gradual approximation of legal standards to the standards of the European Community law system, in particular, in ensuring the protection of intellectual property rights in biotechnology, which will have a beneficial effect on the prospect of the emergence of a key innovative legal model with a unified legislative spirals with an understanding of the necessary separation of biotechnologies into an independent legal local intellectual sphere of civilization with an appropriate level of responsibility.

The multifaceted nature of the content of biotechnology has turned a science that studies the possibilities of using living organisms, their systems or their vital products to solve technological problems, as well as the possibility of creating living organisms with the necessary properties by genetic engineering, into one of the areas of industry of important macroeconomic importance. In all leading countries of the world, national and international programs on biotechnology, funded by public and private capital, are developed and are operating, in addition, the results of scientific research in the field of biotechnology. Implement long-term projects with a high degree of risk upon receipt of various commercial products, the development results of which must be reliably protected from competitors, possibly while ensuring the granting of exclusive rights to new products and technologies by patenting. Thus, the protection of the right to biotechnology makes the patent an instrument for transferring technology and protecting new markets in the global economy, where the use of such an instrument is most effective in industries with a high cost of research and development, but low production cost of the final product, typical for biotechnological, microbiological and pharmaceutical industry.

Convincingly, even in a quote by A. Einstein, «Nature shows us only the tail of the lion. But I do not doubt that the lion belongs to it even though he cannot at once reveal himself because of his enormous size.»24, there are warnings regarding a negligent attitude towards the natural uniqueness of biotechnologies and an understanding of the devastating consequences of an incompetent approach to the interpretation of the concepts and processes associated with biotechnologies when creating a domestic regulatory and legal framework for the protection of intellectual property rights in biotechnologies, the need for biopatents, taking into account the supremacy and legal existence of biotechnologies, as objects of intellectual property and a powerful generator of scientific and technological development ia of the country, the guarantor of innovation and financial stability, and, the innermost unexplored possibilities of biotechnology with unpredictable prospects for humanity.


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How to Cite
Kuzmych, I. (1). Legal existentiality of bio-patents is an urgent problem of modern intellectual law-making. Law Review of Kyiv University of Law, (4), 263-271.
Intellectual property law issues