Rules of international law regarding application of the results of scientific researches in the field of biotechnology (on the example of therapeutic and reproductive cloning and human gene editing) and their patent protection

The article is aimed at highlighting a number of issues in the field of legal regulation of innovative medical technologies based on interference in the human genome and cloning (therapeutic and reproductive) in the context of international law (conventions, declarations, bilateral agreements). In this format, the author examined some international acts that created the legal paradigm for regulating scientific research in the field of study, determining the limits of the admissibility of the implementation of the indicated achievements of modern science in clinical medicine, which are designed to be an effective tool in the fight against severe hereditary diseases, etc., which potentially predetermines their demand. The focus of the author’s attention is on the patentability of these biotechnologies. The relevance of such a study is due to the range of issues addressed, since in the absence of proper regulatory regulation of the studied sphere of public relations, domestic high-tech medicine will be forced to engage in “catch-up” development. In the study, such methods of scientific knowledge were used as general scientific dialectics, formal logic and comparative legal methods. At the same time, the author proceeds from both subjective and objective presetting of processes and phenomena, and their interconnection. The novelty of the study is determined by its purpose, subject and range of sources considered. Thus, the author explores the provisions of both normative acts and documents (acts of so-called “soft law”), emphasizing the peculiarities of their legal nature. In this format, the author comes the conclusion that the system of international principles and standards, formed by the considered acts and documents, does not contain explicit permission to carry out scientific research in the biotechnology field with the subsequent commercialization of its results, which can be patented as inventions, that leads to the need to create national legal frameworks by modern states wishing to advance in this field that will result in a mosaic legal map of the world. Where innovative biotechnologies will be spread in the countries -“scientific offshores” providing loyal to these kinds of scientific researches legislation. The theoretical and practical significance of the results is determined by the fact that Russian readers will be provided with up-to-date scientific information on the state of international law in the field under study, which in practical terms will contribute to the awareness of the sufficiency (or insufficiency) of the developed international legal mechanism for regulating the sphere of biotechnology, including positions of patent and legal protection of a number of“breakthrough” biotechnologies of applied nature, and will also help to establish the unification level of domestic legislation with the approaches laid down in the studied international acts and documents.

soft law, genomic research, regulatory principles, patent, biotechnology, international treaty, BRICS, 3D - bioprinting, therapeutic cloning, reproductive cloning