DOI: 10.7256/2454-0706.2020.9.33797

Abstract: The object of this research is the determination of legal nature of genomic research data and their role among the objects of civil law. The subject of this research is the data of preclinical and clinical studies of pharmaceutical products, mostly those that contain biomaterial and biomedical cell products. The author underlines the problem of the absence of due legal regulation of genomic research data as the objects of law within Russian legislation, as well as protection of their rightsholders from anticompetitive use. The author reveals the possibility of recognizing genomic research data as the results of intellectual activity that are subject to legal protection as objects of intellectual property, as well as the need to enshrine them in the provisions of the Part 4 of the Civil Code of the Russian Federation. The main conclusion consists in the substantiation of the need for protection of genomic research data as the objects of civil law. Arguments are adduced on the potential reference of genomic research as the results of intellectual activity to the objects of intellectual property. The list of data that may comprise trade secret is subjected to critical analysis. The author proposes the original classification of the results of intellectual activity as the objects of intellectual property from the perspective of the presence of creative beginning as directly invented by human, and indirectly reflecting the result of human activity. The conclusion is formulated on the independent nature of the results of genomic research as the objects of intellectual property in the form of the results of intellectual activity. The author underlines the need for protecting genomic research data as a variety of results of such tests as the know-how, as well as corresponding revision of legal definition of trade secret captured in civil legislation.

DOI: 10.7256/2454-0706.2020.9.43372

Abstract: The object of this research is the determination of legal nature of genomic research data and their role among the objects of civil law. The subject of this research is the data of preclinical and clinical studies of pharmaceutical products, mostly those that contain biomaterial and biomedical cell products. The author underlines the problem of the absence of due legal regulation of genomic research data as the objects of law within Russian legislation, as well as protection of their rightsholders from anticompetitive use. The author reveals the possibility of recognizing genomic research data as the results of intellectual activity that are subject to legal protection as objects of intellectual property, as well as the need to enshrine them in the provisions of the Part 4 of the Civil Code of the Russian Federation. The main conclusion consists in the substantiation of the need for protection of genomic research data as the objects of civil law. Arguments are adduced on the potential reference of genomic research as the results of intellectual activity to the objects of intellectual property. The list of data that may comprise trade secret is subjected to critical analysis. The author proposes the original classification of the results of intellectual activity as the objects of intellectual property from the perspective of the presence of creative beginning as directly invented by human, and indirectly reflecting the result of human activity. The conclusion is formulated on the independent nature of the results of genomic research as the objects of intellectual property in the form of the results of intellectual activity. The author underlines the need for protecting genomic research data as a variety of results of such tests as the know-how, as well as corresponding revision of legal definition of trade secret captured in civil legislation.

DOI: 10.25136/2409-7136.2020.7.33796

Abstract: The object of this research is the determination of means of establishing the results of genomic research as the objects of intellectual property. The author analyzes the Russian normative legal acts regulating the questions of conducting genomic research and securing the rights to their results. The problem of absence of the universal definition and conceptual framework for genomic research in the national legislation is indicated. Analysis is carried out on the defended in legal community scientific positions pertaining to the need for separate consolidation and legal regulation of each type of product or organism that contains genes, or derivative from biomaterial, as well as the genes and genome themselves. The main conclusions consists in formulation and substantiation of the concept of “genomic research” and the results of genomic research. The original classification of the results of genomic research into static and dynamic is proposed. The author believes that the intellectual property law is most suitable for legal regulation and consolidation of the rights to results of genomic research. Inexpedience of determining each type of product or organism that creates or contains biomaterial as an object of intellectual property is substantiated. The author holds that the amendments to legislation should be introduced in exceptional circumstances when a new object possesses unique characteristics, and the existing tools of intellectual property law do not allow reflecting its specificity and protect the interests of its bearer.

DOI: 10.25136/2409-7136.2019.6.30137

Abstract: The aim of this research is to discover and analyze legal principles of using human corpse as biological material and source of genomic information. In the course of her research, Belaya has analyzed Russian laws that regulate the process of collecting and using tissues, body organs and corpse of a dead individual and set forth rules for collection, use, storge and destruction of genomic information. The researcher describes wills that express consent or non-consent of using an individual's corpse, tissue and organs after his or her death as well as procedures of obtaining such consent from relatives or legal representatives. The researcher focuses on the problems arising in the process of legal fixation and practical implementation of particular legal principles in the course of using human corpse as genetic material. The methodological base of the research includes a combination of general and special research methods such as analysis, legal modelling and forecasting, dialectical materialistic, structural functional, legal logical, comparative legal and systems approches. The main outcome of the rsearch is analysis of current laws on collection and use of human corpse as genetic material and source of genomic information, collisions and contradictions in associated legislation and recommendations on how to eliminate them. The author also offers her own classification of legal principles of using human corpse as genetic material and source of genomic information. She also defines general and special legal principles of using such objects of civil circulation.