Introduction: advances in the field of genetic engineering and gene technologies make it possible not only to extract particular genes (fragments of genes) that encode certain properties of an organism (including human) but also to modify them. Such possibilities pose complex problems for mankind, including legal, moral and ethical ones. Among these problems is the potential for establishing a legal monopoly (in particular, using patent law mechanisms) on the results of such activities. The article discusses approaches existing in different legal systems to patenting a gene sequence, possibilities of recognizing a gene (its part) as an item covered by exclusive rights, primarily as an invention. There are identified criteria that ensure patentability of inventions where the subject matter is a gene sequence (gene, part of a gene) regarded as a substance: novelty, inventive level, industrial applicability. The paper also analyzes the possibilities and risks of protecting the rights to an identified gene sequence as a production secret (know-how). Purpose: to identify the most effective models for the legal protection of genetic research results, to determine approaches to the allowability of patenting a gene sequence as a substance, to define protectability criteria for such inventions provided that these criteria would mitigate the conflict between the rightholders' and society's interests. Methods: dialectical, formal logical, functional and other general scientific methods; special legal methods: comparative legal and formal legal, as well as the method of legal transformation of natural scientific concepts into legal categories. Results: there have been identified and characterized different approaches applied in various legal systems to patenting a gene (part of a gene) as a substance: fundamental allowability, existing restrictions. The features of the application of protectability criteria to inventions in this area have been studied. The existing risks and the mechanisms proposed for minimizing those in different legal systems have been identified. Based on a comparative analysis, the paper demonstrates the need for legal formalization of special requirements for the protectability of genetic inventions. Taking into account the possibilities of protecting a gene (its part) as know-how, the effectiveness and potential risks of using this protection model have also been analyzed. Conclusions: analysis of international legal documents and approaches of different legal systems demonstrates the need for a clearer distinction between the concepts 'discovery' and 'invention' in the field of genetic research. Currently, most legal systems, including the Russian one, recognize the fundamental possibility of patenting a gene (its part), but under certain conditions, applied to prevent monopolization of knowledge about nature as such. The selection of a protection model that does not involve disclosure of information on the obtained scientific results (know-how) is undesirable from the political and legal points of view. Granting exclusive rights to an invention related to a gene sequence identification entails risks to safety, health, and well-being of a person; therefore, stricter rules limiting such rights are necessary. At the same time, there should be offered incentives (proprietary first of all) supported by modern patent law that would promote research and new developments in the field of biotechnology.
