Patenting Microbial Strains
https://doi.org/10.17803/lexgen-2025-4-2-7-27
Abstract
A priority direction for Russian science is defined in the Decree of the President of the Russian Federation of November 28, 2018 No. 680 “On the development of genetic technologies in the Russian Federation”. The development of genetic technologies will be pursued in accordance with the corresponding Federal Scientific and Technical Program. In order to achieve this goal it will be necessary to develop mechanisms of legal support governing the use of genetic technologies from the stage of scientific research to the implementation of developed results in commercial production. The scientific interest in this problem is due to the currently insufficient legal regulation of relations arising in connection with the use of genetic technologies. However, due to the lack of empirical data, some aspects of the problem must be predicted on the basis of assumptions. Taken together, these problems hinder the active dissemination and implementation of genetic technologies. The purpose of this study is to establish and elucidate issues involved in patenting strains of microorganisms. Microorganism strains represent objects that can be used for scientific and other applications in the context of genetic technologies. Civil law currently permits the patenting of such objects due to their perceived status as an invention. However, despite its objective specificity, there are no additional regulations for governing this process. The concepts of microorganism and strain are presented along with the correct and applicable conditions for their patenting. Examples from foreign experience demonstrate a diversity of national approaches to the procedure for issuing a patent for such inventions. The author offers an opinion regarding the normative consolidation of the analyzed process. The existing Russian regulatory environment features many strong points that can be developed for the patenting of microorganism strains taking into account international experience.
Keywords
genetic technologies,
microorganisms,
microorganism strains,
natural product,
patents,
patentability conditions
Supporting agencies: The study was conducted within the framework of the project of the Ministry of Science and Higher Education of the Russian Federation, register number 30000F.99.1.BV16AA01000, “Scientific and methodological support of works on legal regulation of accelerated development of genetic technologies”.
About the Author
D. O. Osmanova
Kutafin Moscow State Law University (MSAL)
Russian Federation
Russian Federation
Diana O. Osmanova, Candidate of Science (Law), Associate Professor of the Department of Civil Law
Moscow
References
1. Balachandra Nair, R., Ramachandranna, P. C. (2010). Patenting of microorganisms: Systems and concerns. Journal of Commercial Biotechnology, 16, 337-347. https://link.springer.com/article/10.1057/jcb.2010.20#rightslink
2. Boltanova, E.S. (2023). Civil law. Special part. Moscow: INFRA-M Publ. (In Russ.).
3. Churilov, A.Y. (2020). Legal regulation of intellectual property and new technologies: challenges of the XXI century. Moscow: Justitsinform Publ. (In Russ.).
4. Correa, C.M. (2012). A guide to pharmaceutical patents. Geneva: South Centre. https://www.southcentre.int/wp-content/uploads/2016/05/Bk_2012_A-Guide-to-Pharmaceutical-Patents_EN.pdf.
5. Dozortsev, V.A. (2005). Intellectual Property Rights: Concept. System. Tasks of codification. Collection of articles. Moscow: Statut Publ. (In Russ).
6. England, P. (2022). A Practitioner’s Guide to European Patent Law. Bloomsbury Academic. https://doi.org/10.5040/9781509947676
7. Gavrilov, E.P. (2021). On Certain Issues Relating to Intellectual Rights Objects. Economy and Law, (10), 56–61. (In Russ.).
8. Gorlenko, S.A., Kalyatin, V.O., Kirii, L.L., Kozyr', O.M., Korchagin, A.D., Orlova, V.V., Pavlova, E.A., Sinel'nikova, V.N., Stepanov, P.V., Trakhtengerts, L.A., Shilokhvost, O.Yu. (2016). Commentary to the Civil Code of the Russian Federation (Part Four): in 2 vol. (article-by-article). Moscow: INFRA-M Publ. (In Russ.).
9. Grishaev, S.P. (2022). Civil Code of the Russian Federation. Part four. Article-by-article commentary. SPS ConsultantPlus. (In Russ.)
10. Ilić, N. (2024). Law and Economics of Patents: Theory, Economic Impact, and Future Trends. Springer. https://doi.org/10.1007/978-3-031-62860-3
11. Laskar, M. (2013, August 24). Patentability of Life Forms (USA, Europe & Asia). SSRN. http://doi.org/10.2139/ssrn.2408510
12. Morgunova, E.A., Shakhnazarov, B.A. (2023). The right of intellectual property in the conditions of development of new technologies. Moscow: Norma Publ., INFRA-M Publ. (In Russ.).
13. Ponkin, I.V. (2016). On the criteria of patentability of inventions in the field of biobjects, biomaterials and biotechnology. Intellektual'naya sobstvennost'. Promyshlennaya sobstvennost' [Intellectual Property. Industrial Property], (8), 41–50. (In Russ.).
14. Samodurova, S.S. (2024). Absolute unpatentability of inventions in the field of biomedicine on the grounds of contradiction to public policy. Zhurnal Suda po intellektual'nym pravam [Journal of the Intellectual Property Rights Court], (1), 102–108. (In Russ.).
15. Singh, K.K. (2014). Biotechnology and intellectual property rights: legal and social implications. Springer. https://doi.org/10.1007/978-81-322-2059-6
16. Smith, J. (1996). Biotechnology. Cambridge University Press.
17. Sprott, W.D. (2013). From Pine Straw to CDNA: The History of the Product of Nature Doctrine. Houston Business and Tax Law Journal, 14(2), 290–322. https://hbtlj.org/wp-content/uploads/2021/10/Sprott.pdf
18. Stasi, A., David, T. W. C. (2023). An Introduction to Legal, Regulatory and Intellectual Property Rights Issues in Biotechnology. Bentham Science Publishers. https://doi.org/10.2174/97898150806291230101
19. Thouvenin, F., Peukert, A., Jaeger, T., Geiger, C. (2024). Kreation Innovation Märkte-Creation Innovation Markets: Festschrif t Reto M. Hilty. Springer Verlag. https://doi.org/10.1007/978-3-662-68599-0
20. Thumm, N. (2004). Strategic patenting in biotechnology. Technology Analysis & Strategic Management, 16(4), 529–538. https://doi.org/10.1080/0953732042000295829
21. Tsilyurik, U.S. (2022). Patenting a method as an object of invention: issues of theory, law enforcement practice and improvement of legislation. Zhurnal Suda po intellektual'nym pravam [Journal of the Intellectual Property Rights Court], (2), 71–82. (In Russ.).
22. Xiaolan, R. (2024). Patent Administrative Litigation: Rules and Review. Springer Nature. https://doi.org/10.1007/978-981-97-1131-4
Review
For citations:
Osmanova D.O. Patenting Microbial Strains. Lex Genetica. 2025;4(2):7-27. (In Russ.) https://doi.org/10.17803/lexgen-2025-4-2-7-27
Views:
9
Email this article 