Perm University Herald. Juridical Sciences. 2020. Issue 2 (48)


L. A. Novoselova, Kutafin Moscow State Law University (MSAL) 

This email address is being protected from spambots. You need JavaScript enabled to view it.
ORCID: 0000-0001-8463-178Х ResearcherID: G-5278-2017
Articles of «Scopus» & «Web of Science»:       ---

M. A. Kolzdorf, Intellectual Property Court

This email address is being protected from spambots. You need JavaScript enabled to view it.
ORCID: 0000-0003-3227-3348 ResearcherID: AAI-1625-2019
Articles of «Scopus» & «Web of Science»:       ---
Requisites: Novoselova L. A., Kolzdorf M. A. Geneticheskaya informatsiya kak ob"ekt intellektual'nykh prav [Genetic Information as Intellectual Property].Vestnik Permskogo universiteta. Juridicheskie nauki – Perm University Herald. Juridical Sciences. 2020. Issue 48. Pp. 290–321. (In Russ.). DOI: 10.17072/1995-4190-2020-48-290-321
DOI: 10.17072/1995-4190-2020-48-290-321

Introduction: advances in the field of genetic engineering and gene technologies make it possible not only to extract particular genes (fragments of genes) that encode certain properties of an organism (including human) but also to modify them. Such possibilities pose complex problems for mankind, including legal, moral and ethical ones. Among these problems is the potential for establishing a legal monopoly (in particular, using patent law mechanisms) on the results of such activities. The article discusses approaches existing in different legal systems to patenting a gene sequence, possibilities of recognizing a gene (its part) as an item covered by exclusive rights, primarily as an invention. There are identified criteria that ensure patentability of inventions where the subject matter is a gene sequence (gene, part of a gene) regarded as a substance: novelty, inventive level, industrial applicability. The paper also analyzes the possibilities and risks of protecting the rights to an identified gene sequence as a production secret (know-how). Purpose: to identify the most effective models for the legal protection of genetic research results, to determine approaches to the allowability of patenting a gene sequence as a substance, to define protectability criteria for such inventions provided that these criteria would mitigate the conflict between the rightholders’ and society’s interests. Methods: dialectical, formal logical, functional and other general scientific methods; special legal methods: comparative legal and formal legal, as well as the method of legal transformation of natural scientific concepts into legal categories. Results: there have been identified and characterized different approaches applied in various legal systems to patenting a gene (part of a gene) as a substance: fundamental allowability, existing restrictions. The features of the application of protectability criteria to inventions in this area have been studied. The existing risks and the mechanisms proposed for minimizing those in different legal systems have been identified. Based on a comparative analysis, the paper demonstrates the need for legal formalization of special requirements for the protectability of genetic inventions. Taking into account the possibilities of protecting a gene (its part) as know-how, the effectiveness and potential risks of using this protection model have also been analyzed. Conclusions: analysis of international legal documents and approaches of different legal systems demonstrates the need for a clearer distinction between the concepts ‘discovery’ and ‘invention’ in the field of genetic research. Currently, most legal systems, including the Russian one, recognize the fundamental possibility of patenting a gene (its part), but under certain conditions, applied to prevent monopolization of knowledge about nature as such. The selection of a protection model that does not involve disclosure of information on the obtained scientific results (know-how) is undesirable from the political and legal points of view. Granting exclusive rights to an invention related to a gene sequence identification entails risks to safety, health, and well-being of a person; therefore, stricter rules limiting such rights are necessary. At the same time, there should be offered incentives (proprietary first of all) supported by modern patent law that would promote research and new developments in the field of biotechnology.

Keywords: intellectual property; patents; inventions; genetic information; gene; gene patenting; know-how
  download the full-version article
References: 1. Аbdullin А. I. Pravovaya okhrana biotekhnologicheskikh izobretenij: evropejskij opyt [Legal Protection of Biotechnological Inventions: European Experience]. Vestnik ekonomiki, prava i sotsiologii – The Review of Economy, the Law and Sociology. 2008. Issue 6. Pp. 66–78. (In Russ.).
2. Vorozhevich А. S. Patentovanie rezul'-tatov geneticheskikh issledovanij: zarubezhnyj opyt [Patenting the Results of Genetic Research: Foreign Experience]. Khozyajstvo i pravo – Business and Law. 2019. Issue 6 (509). Pp. 9–20. (In Russ.).
3. Vvedenie v intellektual'nuyu sobstvennost'. Publikatsiya Vsemirnoj organizatsii intellektual'noj sobstvennosti № 478 (R) [Introduction to Intellectual Property. Publication of the World Intellectual Property Organization No. 478 (R)]. Geneva, 1998. 652 p.
4. Gutnikov O. V., Sinitsyn S. А., Аyuro-va А. А., Tsomartova F. V. Zashhita isklyuchitel'nykh prav na izobreteniya, ispol'zuemye v lekarstvennykh preparatakh: problemy pravovogo regulirovaniya i napravleniya sovershenstvovaniya zakonodatel'stva: monografiya / otv. red. O. V. Gut¬nikov, S. A. Sinitsyn [Protection of Exclusive Rights to Inventions Used in Medicines: Problems of Legal Regulation and Directions for Improving Legislation: Monograph; ed. by O. V. Gutnikov, S. A. Sinitsyn]. Moscow, 2019. 208 p. Access from the legal reference system 'ConsultantPlus'. (In Russ.).
5. Inshakova А. O., Ryzhenkov А. Ya., Bogdanova T. D. Pravovaya zashhita biotekhnologij v RF: preimushhestva patentovaniya i kriterii patentosposobnosti [Legal Protection of Biotechnologies in Russia: Benefits of Patenting and Patentability Criteria]. Vestnik Volgogradskogo gosudarstvennogo universiteta. Seriya 5. Yurisprudentsiya – Science Journal of Volgograd State University. Jurisprudence. 2015. Issue 3 (28). Pp. 26–34. (In Russ.).
6. Kol'zdorf M. Spornye voprosy patentovaniya genov cheloveka [Controversial Issues of Human Genes Patenting]. Khozyajstvo i pravo – Business and Law. 2019. Issue 3 (506). Pp. 60–69. (In Russ.).
7. Kommentarij k chasti chetvertoj Grazhdanskogo kodeksa Rossijskoj Federatsii (postatejnyj) / otv. red. E.A. Pavlova [Commentary to Part Four of the Civil Code of the Russian Federation (Article by Article); ed. by E. A. Pavlova]. Moscow, 2018. 925 p. (In Russ.).
8. Kommentarij k Grazhdanskomu kodeksu Rossijskoj Federatsii (chasti chetvertoj) (postatejnyj): v 2 t. / otv. red. L. А. Trakhtengerts. 2-e izd. [Commentary to the Civil Code of the Russian Federation (Part Four) (Article by Article): in 2 vols.; ed. by L. А. Trakhtengerts. 2nd ed.]. Moscow, 2016. Vol. 2. 524 p. Access from the legal reference system 'ConsultantPlus'. (In Russ.).
9. Novoselova L. A., Petrosyan G. G. Genom kak ob"ekt intellektual'nykh prav v rossijskom prave: Konstitutsiya Rossijskoj Federatsii i sovremennyj pravoporyadok [Genome as an Object of Intellectual Rights in Russian Law: the Constitution of the Russian Federation and the Modern Legal Order]. Moscow, 2019. Part 3. 264 p. (In Russ.).
10. Ponkin I. V. Patenty na biotekhnologicheskie izobreteniya, svyazannye s genetikoj chelovecheskogo organizma [Patents for Biotechnological Inventions Related to Genetics of a Human Organism]. Kopirajt. Vestnik Rossijkoj akademii intellektual'noj sobstvennosti i Rossijskogo avtorskogo obshhestva – Copyright. Bulletin of the Russian State Academy of Intellectual Property and Russian Authors Society. 2015. Issue 3. Pp. 36–41. (In Russ.).
11. Ponkin I. V. Patentovanie v sfere biotekhnologij [Patenting in the Field of Biotechnology]. Promyshlenno-torgovoe pravo – Industrial and Commercial Law. 2015. Issue 10. Pp. 88–91. (In Russ.).
12. Ponkin I. V. O kriteriyakh patentosposobnosti izobretenij v oblasti bioob"ektov, biomaterialov i biotekhnologij [On Patentability Criteria for Inventions in the Field of Biological Objects, Biomaterials and Biotechnologies]. Intellektual'naya sobstvennost'. Promyshlennaya sobst¬vennost' – Intellectual Property. Industrial Property. 2016. Issue 8. Pp. 41–50. Access from the legal reference system 'ConsultantPlus'. (In Russ.).
13. Pravo intellektual'noj sobstvennosti: uchebnik / pod. obshh. red. Novoselovoj L. A. [Intellectual Property Law: Textbook; ed. by L. A. No¬voselova]. Vol. 4. Patentnoe pravo [Patent Law]. Moscow, 2019. 118 p. (In Russ.).
14. Romanova S. Razvitie biotekhnologij v Rossii [Biotechnologies in Russia]. Remedium – Remedium. 2012. Issue 7. Access from the legal reference system 'Garant'. (In Russ.).
15. Salitskaya E. А. Razgranichenie ponyatij «izobretenie» i «otkrytie» v kontekste pravovoj okhrany dostizhenij v oblasti gennoj inzhenerii. Doklad i obsuzhdenie na XI Ezhegodnoj nauchnoj konferentsii RIEPP [Demarcation of the Concepts 'Invention' and 'Discovery' in the Context of Legal Protection of Genetic Engineering Developments. Proceedings of the Annual Conference of RIEPL: The Report and Panel Discussion]. Upravlenie naukoj i naukometriya – Science Governance and Scientometrics. 2016. Issue 2 (20). Pp. 104–121. Available at:¬ni¬che¬nie-ponyatij-izobretenie-i-otkryitie-v-kontekste-pravovoj-ohranyi-dostizhenij-v-oblasti-gennoj-inzheneri (accessed 03.06.2020). (In Russ.).
16. Patentgesetz (PatG), Kommentar; ed. by Benkard G. 11th ed., revised. Munich, 2015. (In Germ.).
17. Ciechanowski P. The Unnerving Frontier: Human Gene Patenting in Canada. April 6, 2016. P. 6. Available at: sol3/papers.cfm?abstract_id=2884430 (accessed 06.03.2020). (In Eng.).
18. Gutiérrez E. Current Examination Practice in Mexico: Which Biotech Inventions are Allowable by the Mexican Patent Office? Available at: current-examination-practice-in-mexico-which-biotech-inventions-are-allowable-by-the-mexican-patent-office/ (accessed 11.02.2020). (In Eng.).
19. Gonzalez-Vargas M. Patenting Microorganisms in Mexico, 05.09.2018. Available at: (accessed 11.02.2020). (In Eng.).
20. Herrlinger K.A. Die Patentierung von Krankheitsgenen: dargestellt am Beispiel der Patentierung der Brustkrebsgene BRCA 1 und BRCA 2. Cologne, 2005. 432 p. (In Germ.).
21. Hildt E., Kovács L. Was bedeutet genetische Information? Berlin, New York, 2009. 147 p. (In Germ.).
22. HIV Can Develop Resistance to CRISP / Cas9. Science New. April 7, 2016. Available at: 0407132307.htm (accessed 11.02.2020). (In Eng.).
23. Holzapfel H., Schneider M. Wem gehört das menschliche Genom? Tagung am 28 Juni 2001 in München. Access from the Beck-Online Legal Reference System. (In Germ.).
24. International Human Genome Sequencing Consortium. Finishing the Euchromatic Sequence of the Human Genome. Nature Journal. 2004. Pp. 931–945. Available at: articles/nature03001 (accessed 11.02.2020). (In Eng.).
25. Kunczik N. Geistiges Eigentum an genetischen Informationen. Baden-Baden, 2007. 265 p. (In Germ.).
26. La patente, pieza clave que mejora la vida. Available at: (accessed 11.02.2020). (In Span.).
27. Son M. Patentable Subject Matter – What's New? Available at: Article/3532463/Korea-Patentable-subject-matter¬whats-new.html?ArticleId=3532463 (accessed 11.02.2020). (In Eng.).
28. Then C., Schweiger T. Gene, Monopole und 'Life Industry'. Eine Dokumentation über die Patentierung von Leben. 2000. Access from the Beck-Online Legal Reference System. (In Germ.).
29. Werner G. Entnahme und Patentierung menschlicher Körpersubstanzen: eine zivil- und patentrechtliche Beurteilung am Beispiel von menschlichen Antikörpern und Genen. Tübingen, 2008. 254 p. (In Germ.)
Received: ---
Financing: Acknowledgments: The reported study was funded by RFBR, project number 18-29-1407




The Perm State University
614990, Perm, street Bukireva, 15
+7 (342) 2 396 275
ISSN 1995-4190 ISSN (eng.) 2618-8104
ISSN (online) 2658-7106
DOI 10.17072/1995-4190
(с) Editorial board, 2010
The magazine is registered in Federal Agency of supervision in sphere of communication and mass communications.
The certificate on registration of mass media ПИ № ФС77-33087 from September, 5th, 2008
The certificate on reregistration of mass media ПИ № ФС77-53189 from Marth, 14th, 2013

The magazine is included in List ВАК and in the Russian index of scientific citing

The founder & Publisher: the State educational institution of the higher training
“The Perm State University”.
Publishing 4 times a year