Legal status of biomedintellectproduct classification mutation
Authors: Kuzmych Iryna 
Published: March 2021

The multifaceted nature of the content of biotechnology has turned a science that studies the possibilities of using living orga -nisms, 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 leadingcountries of the world, national and international programs on biotechnology, funded by public and private capital, are developed andare operating, in addition, the results of scientific research in the field of biotechnology. Implement long-term projects with a highdegree 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 theright 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 productioncost of the final product, typical for biotechnological, microbiological and pharmaceutical industry.The article is devoted, in essence, to the legal identification of a biomedical product, its content, as an object of intellectual pro -perty. It is indicated, using the example of strains and biosimilars, on the unique individual variability of properties and the content ofbiotechnologies, which is prone to constant mutation, as objects of intellectual property, which can directly affect the protection andprotection of biopatents. Risks of the use of post-patent non-comparable biotherapeutic drugs, which are not identical to the originalbiotechnological drugs in three directions: quality, safety, efficacy, are presented in detail, as an example of the necessary legislativecontrol. Attention is drawn to the need for legal classification and the lack of clarity in the definitions of intellectual property objectsfor biotechnology in international and domestic regulatory legal acts, which negatively affect the formation of the legal status ofbiotechnologies, and are mirrored on the use of legal tools for patenting.The article presents an examination of the current classical legislation in the plane of a legal innovation model, taking intoaccount the signs of legislative default and the absence of judicial practice, with a proposal for a reset of the domestic legislative systemin the field of intellectual property on biotechnology, which is strategically very important for the state. The problems of the nationallegal system in the field of intellectual property on biotechnology are outlined, taking into account the emergence of fundamentally newobjects of intellectual property generated by transplantation, cloning and robotization, regarding the determination of the legal status ofthese objects. It is investigated that high-quality provision of protection and protection of intellectual property objects consists in thedevelopment of a relevant legislative procedure on a highly specialized competent basis, taking into account the constant dynamic andinnovative intellectual exclusivity.