Principles of Biological Safety in Intellectual Property Law

The impact of many modern biotechnologies on health and the environment has not yet been sufficiently studied. In recent years, we have witnessed their intensive development and active application in all new areas of public life, which leads to the need to take into account the principles of biosafety in the legal regulation of not only traditional areas of sanitary and epidemiological supervision and control, but also in other areas, including civil law relations. It is necessary to form a unified legal framework at the intersectoral level in order to take into account the principles of biological safety where legal regulation of intellectual property protection should take a separate place. Thus, patent protection should not be granted to inventions and other results of intellectual activity, the development or use of which may entail an unacceptable level of biological risks (exceptions may be used in certain cases in the interests of national security). The paper examines doctrinal and legislative approaches to concretization and consideration of biosafety principles in law, and it presents proposals for making appropriate changes to Russian law developed on the basis of an analysis of the requirements of special and patent legislation.

1. Agafonov VB, Zhavoronkova NG. Theoretical and Legal Issues of Ensuring Biological Safety of the Russian Federation. Aktual’nye problemy rossijskogo prava. 2020;15(4):187-194, doi: 10.17803/1994-1471.2020.113.4.187-194. (In Russ.).

2. Iroshnikov DV. Security as a legal category. Moscow; 2019. (In Russ.).

3. Letov OV. Bioethics and Contemporary Medicine. RAS. INION. Center for the Humanities Information and Research. Department of Philosophy. Moscow; 2009. (In Russ.).

4. Maleina MN. Role of Legal Principles in Eliminating and Minimizing the Risks of Genomic Technologies. Lex Russica. 2019;(8):121-128, doi: 10.17803/1729-5920.2019.153.8.121-128. (In Russ.).

5. Mokhov AA, Sushkova OV (eds.). Genetic technologies and law during the formation of bioeconomics. Moscow: Prospekt Publ.: 2020. (In Russ.).

6. Mokhov AA. Bioethical principles and biosafety. Medical Law. 2021;4:16-21. (In Russ.).

7. Mokhov AA. Cases on prevention of harm in the future (on the example of genomic researches and implementation of their results in practice). Herald of Civil Procedure. 2019;2:105-120. (In Russ.).

8. Mokhov AA. Is synthetic biology a type of activity that creates increased danger to others? Civilist. 2023;1:5- 11. (In Russ.).

9. Mokhov AA. The Concept of Four «Bio» in Law and Legislation. Aktual’nye problemy rossijskogo prava. 2020;15(8):146-154, doi: 10.17803/1994-1471.2020.117.8.146-154. (In Russ.).

10. Mokhov AA. The potential of self-regulation in ensuring biological security. Civil Law. 2022;1:41-44. (In Russ.).

11. Morgunova EA. Ethical aspects of providing legal protection to the results of intellectual activity obtained during genomic research. In: Protection of individuals’ rights when using genomic technologies: A civil law aspect. Moscow: Prospekt Publ.; 2022. (In Russ.).

12. Nazarenko SV. Sotsialnyy kontrol nauchnoy deyatelnosti issledovatelya i ee rezultatov: metodicheskie i tekhnologicheskie osnovy [Social control of the researcher’s scientific activity and its results: methodological and technological foundations]. Economics, Sociology and Law. 2017;1:48-77. (In Russ.).

13. Novoselova LA, Vorozhevich AS, Domovskaya EV, et al. Legal Protection of the results of genetic research as objects of intellectual rights. Moscow: Prospekt Publ.; 2022. (In Russ.).

14. Romanovsky GB, Romanovskaya OV. Pravovoe regulirovanie biomeditsinskikh tekhnologiy v Rossiyskoy Federatsii [Legal regulation of biomedical technologies in the Russian Federation]. Vestnik Rossiyskogo gumanitarnogo nauchnogo fonda. 2015;3:102-112. (In Russ.).

15. Sergeev DN, Kazachenko IYa, Bolkov MA, et al. Legislation and criminal policy. Moscow: Prospekt Publ.; 2021. (In Russ.).

16. Shevyrev DN. Presumption of biological danger: the principle of human economic activities. Medical Law. 2022;1:39-44. (In Russ.).

17. Sinitsyn SA. Comparative patent law: Actual problems. Institute of Legislation and Comparative Law under the Government of the Russian Federation. Moscow: Infotropik Media Publ.; 2022. (In Russ.).

18. Umnova-Konyukhova IA. Biosecurity law, biolaw and biojurisprudence: the correlation of concepts and their content. Constitutional and Municipal Law. 2023;12:20-26. (In Russ.).

19. Yavorsky AN. Genetic technologies and biosafety: history and modernity. In: Mokhov AA, Sushkova OV (eds.). Genetic technologies and law during the formation of bioeconomics. Moscow: Prospekt Publ.; 2021. (In Russ.).

20. Yudin BG. The boundaries of the human being in the world of new technologies. Workbooks on Bioethics. Issue 12: Tishchenko PD (ed.). Bioethical Support for the innovative development of biomedical technologies. Moscow; 2011. (In Russ.).

21. Zhavoronkova NG, Agafonov VB. Theoretical and Methodological Problems of Legal Support of Ecological, Biosphere and Genetic Safety in the System of National Security of the Russian Federation. Lex Russica. 2019;1(9):96-108, doi: 10.17803/1729-5920.2019.154.9.096-108. (In Russ.).