Law. Human. Environment

Fundamentals of patent protection in the field of biotechnology

Oleksii Piddubnyi, Oleksandr Svitlychnyi
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Abstract

This article covers the concept of patent protection bases in the field of biotechnology. The urgency of the work lies in the need to establish and determine the relationship between patent protection of biotechnology and the legislation of Ukraine, as there is no proper regulation in national legislation. The purpose of the study is conditioned upon the analysis of certain legal issues of biotechnology protection, the need to highlight the features of the legal regulation of relations in the field of biotechnology in international and Ukrainian regulations. During the study, the authors used the following methods to obtain, process and present information: general science (formal-logical, methods of analysis and synthesis, comparison, methods of induction and deduction) and special-legal methods (formal-legal, comparative-legal). The results of the study revealed some inconsistencies in the legislation of the European Union, in particular in the provisions of Directive 98/44 on the conformity of the concept of model, but at the same time worked out the scope of relevant regulations and their functions. It is investigated that there are certain ethical problems in the aspect of human cloning and further development of mankind. The need to adjust the current legislation has been identified. The results of this work, including its components, can be useful for both lawyers in the field of intellectual property law and medical professionals. The practical significance of the article is characterised by a comprehensive study of patents in the field of biotechnology, and an attempt to amend existing Ukrainian legislation in the field of patenting and intellectual property law. The authors consider it expedient to adopt the Law of Ukraine “On Biotechnology Protection”, which should provide criteria for compliance with publicity and morality, based on Ukrainian law, when inventions as an object of intellectual property rights can be considered non-patentable

Keywords

health care, patent law, agriculture, intellectual property rights, intellectual law

Suggested citation
Piddubnyi, O., & Svitlychnyi, O. (2022). Fundamentals of patent protection in the field of biotechnology. Law. Human. Environment, 13(1), 43-49. https://doi.org/10.31548/law2022.01.005
References

[1] Directive 98/44/EC of the European Parliament and of the Council “On the Legal Protection of Biotechnological Inventions”. (1998, July). Retrieved from https://eur-lex.europa.eu/legal-content/EN/ TXT/?uri=celex%3A31998L0044.

[2] Ponomareva, L. (2021). The experience of EU countries in the ethical aspects of patenting biotechnology in medicine and pharmacy. Theory and Practice of Intellectual Property, 2, 23-28.

[3] Altindis, E. (2021). Inequitable COVID-19 vaccine distribution and intellectual property rights prolong the pandemic. Expert Review of Vaccines, 24(8), 427-430. doi: 10.1080/14760584.2022.2014819.

[4] Gerasimenko, V.G., Gerasimenko, М.О., & Tsvilikhovsky, M.I. (Eds.). (2006). Biotechnology. Kyiv: Firm “INCOS”.

[5] Morality: An important consideration at the patent office. (2020). Retrieved from https://lawcat.berkeley. edu/record/1149818.

[6] Bavec, S., & Raspor, P. (2002). Patenting biotechnological inventions in Europe. Food Technol and Biotechnol, 40(4), 353-358.

[7] Tai, C.C., Yi-Liang, Ch., Kalfirt, L., Masodsai, K., Su, Ch.T., & Yang, A. (2022). Differences between elite male and female badminton athletes regarding heart rate variability, arterial stiffness, and aerobic capacity. International Journal of Environmental Research and Public Health, 19(6), article number 3206.

[8] Biopharmaceutical patent protection vs. generic drug competition: Traversing the public policy tightrope. (n.d.). Retrieved from https://www.sciencedirect.com.

[9] Comitato Nazionale per la Bioetica. Identitá e statuto dell’embrione. (n.d.). Retrieved from https://bioetica. governo.it/it/pareri/pareri-e-risposte/identita-e-statuto-dellembrione-umano/#:~:text=Il%20Comitato%20 a%20maggioranza%20ritiene,ritiene%20doveroso%20rispettarlo%20e%20tutelarlo.

[10] Komarova, T.V. (2020). The patentability of biotechnological inventions in the EU: An impact on therapeutic practice. Wiadomości Lekarskie, LXXIII(8), 1747-1751.

[11] Law of Ukraine No. 1678-VII “On Ratification of the Association Agreement between Ukraine, on the One Hand, and the European Union, the European Atomic Energy Community and Their Member States, on the Other Hand”. (2014, September). Retrieved from https://zakon.rada.gov.ua/laws/show/1678-18#Text.

[12] Patent network analysis in agriculture: a case study of the development and protection of biotechnologies. (n.d.). Retrieved from https://www.tandfonline.com.

[13] Seitz, C. (2018). Digital sequence information-legal questions for patent, copyright, trade secret protection and sharing of genomic sequencing data. IOP Conference Series: Earth and Environmental Science, 482, article number 012002.

[14] Healthcare technologies in the age of coronavirus. (n.d.). Retrieved from https://www.epo.org.

[15] Law of Ukraine No. 257/94-B “On Ratification of the Convention on Biological Diversity”. (1994, November). Retrieved from https://zakon.rada.gov.ua/laws/show/257/94-%D0%B2%D1%80#Text.

[16] Brinegar, K., Yetisen, A.K., Choi, S., Vallillo, E., Ruiz-Esparza, G.U., Prabhakar, A.M., Khademhosseini, A., & Yun, S.-H. (2017). The commercialization of genome-editing technologies. Critical Reviews in Biotechnology, 37(7), 924-932. doi: 10.1080/07388551.2016.1271768.

[17] Law of Ukraine No. 3687-XII “On Protection of Rights to Inventions and Utility Models”. (1993, December). Retrieved from https://zakon.rada.gov.ua/laws/show/3687-12#Text. 

[18] Order of the Ministry of Education and Science of Ukraine No. 22 (version of the order No. 578) “On Approval of the Rules for Drawing up and Submitting an Application for an Invention and an Application for a Utility Model”. (2001, January). Retrieved from https://zakon.rada.gov.ua/laws/show/z0173-01.

[19] Sterckx, S. (1998). Some ethically problematic aspects of the proposal for a directive on the legal protection of biotechnological inventions. European Intellectual Property Review, 20(4), 123-128.

[20] Min, Y. (2012). Morality – an equivocal area in the patent system. European Intellectual Property Review, 34(4), 261-265.

[21] Nastyuk, V., Krakovska, A., Utkina, M., Slovska, I., & Shapoval, R. (2019). The peculiarities of legal protection of inventions in the field of biotechnologies: The European experience. Journal of Legal, Ethical and Regulatory Issues, 22(6), 1-7.

[22] Le Gal, C. (2005). La contestation of the directive relative to the protection of biotechnological inventions, lafi n des françaés françaises? La Semaine Juridique General Edition, 11(1), 491-495.

[23] European Union. (2006). Consolidating versions of the treaty on European Union and of the treaty establishing the European Community. Official Journal of the European Union, 49, 321-331. Retrieved from https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2006:321E:0001:0331:EN:PDF.

[24] Kingdom of the Netherlands v European Parliament and Council of the European Union. Retrieved from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A61998CJ0377

[25] Kevles, D., & Berkowitz, A. (2001). The gene patenting contoroversy: A convegence of law, economic interests and ethics. Brooklyn Law Review, 67(1), 233-248.

[26] The German Patent and Trade Mark Office (DPMA). Retrieved from https://www.dpma.de/english/patents/ patent_protection/protection_requirements/biotechnology_and_patents/index.html.

[27] Agreement “On Trade-Related Aspects of Intellectual Property Rights. (1994, April). Retrieved from https://zakon.rada.gov.ua/laws/show/981_018.

[28] Budapest agreement “On the International Recognition of the Deposit of Microorganisms with the Method of Patent Procedure”. (1977, April). Retrieved from https://zakon.rada.gov.ua/laws/show/995_039#Text.

[29] European Patent Organization. (n.d.). Retrieved from http://ndiiv.org.ua/Files2/zakon_EU/30_EPO.pdf.

[30] Barragán-Ocaña, A, Silva-Borjas, P, Olmos-Peña, S, & Polanco-Olguín, M. (2020). Biotechnology and bioprocesses: Their contribution to sustainability. Processes, 8(4), article number 436. doi: 10.3390/pr8040436.

[31] Patenting biotechnology inventions via the EPO. (n.d.). Retrieved from https://cutt.ly/5L8IZj8.