Patentability of Solutions in the Field of Bioprint Technologies: A Comparative Law Aspect

The paper is devoted to the issues of advisability of introducing amendments to the civil legislation in connection with the development of additive technologies or the possibility of effective application of the existing rules of law to the regulation of «innovative» civil relations.

Digitization of objects of the material world associated with the creation of their digital prototypes constitutes a revolutionary element of 3D printing technology. A three-dimensional digital model (CAD file) can be easily modified, distributed and embodied in the form of a physical object by printing it on a 3D printer. This gives rise to new risks of infringement of exclusive rights to objects of patent law. In a foreign doctrine, a discussion has started regarding the possibility of qualifying the creation and circulation of digital models of patented products (inventions) as a direct infringement or indirect infringement of exclusive rights.

The paper concluded that Russian patent law was not ready for the challenge generated by the development of 3D printing technology, since it was not aware of the concept of indirect infringement of the exclusive right. In Russian law enforcement practice, the concept of direct patent infringement is interpreted in a restrictive manner.

The question of admissibility of patenting technical solutions in the field of bioprinting has been studied. It is concluded that in Russian law there are no fundamental obstacles to patenting technical solutions in the field of bioprinting technologies. Russian legislation provides for the possibility of patenting «natural products», as well as methods and means of treatment, which distinguishes the Russian approach from the American or European one. If the risk of genetic instability of pluripotent cells is leveled, the technology for creating bioprinted human organs will comply with the requirements of civil law. In particular, it will meet the requirements for the compliance of patented technical solutions with the public interest, the principles of humanity and morality.

1. Volkova NS, Ermakov AS. Indutsirovannye plyuripotentnye stvolovye kletki i sovremennye metody ikh polucheniya [Induced pluripotent stem cells and modern methods for their production]. Tsarskosel’skie chteniya. 2016;20:255-261 (In Russ.).

2. Gaiduk IE, Novokshenova NA. Sposob lecheniya kak obekt patentnogo prava [Method of treatment as an object of patent law]. Intellectual Property Court Magazine. 2018;9:51-60 (In Russ.).

3. Domovskaya EV. Ogranicheniya vozmozhnosti patentovaniya rezultatov genomnykh issledovaniy v rossiyskom zakonodatelstve [Restrictions of the Possibility of Patenting Genomic Research Results in Russian Laws]. Russian Judge. 2020;5:55-64 (In Russ.).

4. Krasnov AA, Smolentsev EV. Additivnoe i subtraktivnoe proizvodstvo [Additive and subtractive production]. Innovative Science. 2016;12-2:72-75 (In Russ.).

5. Makintayr A. Posle dobrodeteli: Issledovaniya teorii morali [After Virtue: Studies in Moral Theory]. Moscow: Academic project; Yekaterinburg: Business book Publ.; 2000 (In Russ.).

6. Naka KO. Yamanaka Shinya Nobel Prize as an occasion for rethinking the role of science and the mission of a scientist in Japan. Yearbook Japan. 2015;44:92-103.

7. Rashidkhanova DK. O pravovom regulirovanii otnosheniy klonirovaniya genoma cheloveka [On the legal regulation of human genome cloning relations]. Medical Law. 2007;1:5-10 (In Russ.).

8. Siluyanova IV. Bioetika: opredelenie i vidy [Bioethics: definition and types]. Bioethics. 2020;1(25):9-16 (In Russ.).

9. Smirnov KS. Bioetika v narrativnom rakurse: ot «nauki vyzhivaniya» do radikalnoy etiki spaseniya (na materiale rasskaza R. Kiplinga «Chudo Puran Bkhagata») [Bioethics In Narrative Foreshortening: From «Science Of Survival» to the Radical Ethics of Salvation (On the Material of R. Kipling’S Story «The Miracle of Purun Bhagat»)]. Bioethics. 2020;1(25):5-9 (In Russ.).

10. Abinader L. G., Contreras J. L. The Patent Ability of Genetic Therapies: CAR-T and Medical Treatment Exclusions Around the World. American University International Law Abstract. 2019;34(4):705-762.

11. Ballardini RM, Norrgard M, Minssen T. Enforcing patents in the era of 3D printing. Journal of Intellectual Property Law & Practice. 2015;10(11):850-866.

12. Beauchamp Ch. Patenting Nature: A Problem of History. Stanford Technology Law Abstract. 2013;16:257-312.

13. Bohrer RA. A Guide to Biotechnology Law and Business. Carolina Academic Press; 2007.

14. Brean D H. Patenting Physibles: A Fresh Perspective for Claiming 3D-Printable Products. Santa Clara Law Abstract. 2015;55:837-864.

15. De Caria R. Blockchain and Smart Contracts: Legal Issues and Regulatory Responses Between Public and Private Economic Law. The Italian Law Journal. 2020;6(1):363-379.

16. Deakin SF, Markou Ch. The Law-Technology Cycle and the Future of Work (March 2018). University of Cambridge Faculty of Law Research Paper No 32/2018. Available at: https://ssrn.com/abstract=3183061.

17. Deven RD, Magliocca GN. Patents, Meet Napster: 3D Printing and the Digitization of Things. The Georgetown Law Journal. 2014;102:1691-1720.

18. Ghosh S. Gene Patents: Balancing the Myriad Issues Concerning the Patenting of Natural Products. Berkeley Technology Law Journal. 2012;27:241-272.

19. Holbrook TR, Osborn LS. Digital Patent Infringement in an Era of 3D Printing. UC Davis Law Abstract. 2015;48:1319-1385.

20. Lemley MA. IP in a World Without Scarcity. New York University Law Abstract. 2015;90:460-478.

21. Li Phoebe. 3D Bioprinting Technologies: Patents, Innovation, and Access. Law, Innovation and Technology. 2014;6(2):282-304.

22. Osborn LS. Regulating Three-Dimensional Printing: The Converging Worlds of Bits and Atoms. San Diego Law Abstract. 2014;51:553-652.

23. Schwab K. The Fourth Industrial Revolution. 1st ed. World Economic Forum, 2016.

24. Smith S. Claiming a Cell Reset Button: Induced Pluripotent Stem Cells and Preparation Methods as Patentable Subject Matter. Boston College Law Abstract. 2015;56:1577-1598.

25. Tabrez E. 3D Bioprinting Patentable Subject Matter Boundaries. Seattle University Law Abstract. 2017;41(1):1-59.

26. Taylor DO. Amending Patent Eligibility. UC Davis Law Abstract. 2017;50:2149-2213.

27. Torrance AW. Synthesizing Law for Synthetic Biology. Minnesota Journal of Law, Science & Technology. 2010;11(2):629-665.

28. Varkey M, Atala A. Organ Bioprinting: A Closer Look at Ethics and Politics. Wake Forest Journal of Law & Policy. 2015;5(2):275-296.