Legislative convergence on patenting of intellectual property on biotechnology

Keywords: intellectual property, legislative convergence, biotechnology, bio-patenting, strain disposal, biosimilars, biocloning, biorobots

Abstract

Combining the results of intellectual activity in a single biotechnology and the formation of a set of property (exclusive) intellectual
patent rights to such technology, lead to a comprehensive expansion of the sectoral use of biotechnology: food and agricultural,
drugs and industrial products, drugs, diagnostics and reagents, environmental, biological, resource and practical; – from microorganisms
to artificial intelligence with obtaining high liquidity of biotechnological products, the main motive of unfair competition.
First of all, there is a need to reveal the uniqueness of biotechnology as an object of intellectual property, therefore, on the example
of biosimilars proved that biotechnological drugs – substances of protein nature, which are fundamentally different from conventional
synthetic drugs, both in structure and technology production. Therefore, the creation of similar drugs, so-called biosimilars,
requires the formation and application of new thinking, abandonment of “generic” habits, with new highly qualified personnel in the
field of biotechnology to study biosimilarity (biosimilarity), with a special approach to development, research, production control and
taking into account when granting patentability to intellectual property objects on biotechnology.
Undoubtedly, this study proved that intellectual property on biotechnology has properties and natural ability that cause individual
variability in composition and content, respectively, which actually confirms the inauthenticity of other intellectual property, outlines
the prospects for the separation of biotechnology into an independent legal field. with the use, according to the author, within its own
proposal, strengthening measures to protect intellectual biotechnological information, in such a way as legal tokenization.
Thus, a legislative space is created, where international legal acts are of a recommendatory nature in ensuring the protection of
intellectual property rights, in particular, in biotechnology, while, taking into account the above specificity, legal existentiality of
biopatents, where the law must be important in content information, to be an instruction for clear actions in the context of the transformation
of legal regulation in this area, is an unacceptable incompetence in national legislation, which leads to the so-called legislative
default and legislative convergence.
Also, issues related to the use of intellectual property innovations in biotechnology in the form of transplantation, cloning, robo -
tics, which entail legal and socio – ethical obligation and urgency of the model and structure of legal regulation to determine the legal
status of these intellectual property. In addition, the indicators of chronological dynamics are reflected and the obvious aspects of the
unfinished legal framework are indicated, the consequences of deep transformational transformations are exposed, with the prevention
of transition from chaotic lawmaking to legal collapse in case of inaction, incompetence and untimely solution of accumulated legislative
problems.

References

1 Constitution of Ukraine №254k/96-VR (1996, June 26). Vidomosti Verkhovnoyi Rady Ukrayiny, 30, 141. URL: https://zakon.rada.gov.ua/laws/show/254к/96-вр [in Ukrainian].
2 Civil Code of Ukraine № 435-IV (2003, January 16). Vidomosti Verkhovnoyi Rady Ukrayiny, 40-44, 356. URL: https://zakon.rada.gov.ua/laws/show/435-15 [in Ukrainian].
3 Law of Ukraine on Medicines № 123/96-VR (1996, April, 4). Vidomosti Verkhovnoyi Rady Ukrayiny, 22, 86. URL: https://zakon.rada.gov.ua/laws/show/123/96-вр [in Ukrainian].
4 Law of Ukraine On the guard of rights on the sorts of plants No 3116-ХІІ (1993, April, 21) Vidomosti Verkhovnoyi Rady Ukrayiny, 21, 218. URL:https://zakon.rada.gov.ua/laws/show/3116-12
[in Ukrainian].
5 Law of Ukraine On Protection of Rights to Inventions (Utility Models) No. 3687-XII (1993, December 15). Vidomosti Verkhovnoyi Rady Ukrayiny, 7, 32. URL: https://zakon.rada.gov.ua/laws/main/3687-12 [in Ukrainian].
6 Law of Ukraine About the guard of rights on industrial prototypes No. 3688-ХІІ (1993, December 23) Vidomosti Verkhovnoyi Rady Ukrayiny, 7, 34. URL: https://zakon.rada.gov.ua/laws/show/3688-12 [in Ukrainian].
7 Law of Ukraine On the guard of rights on signs for commodities and services No. 3689-ХІІ (1993, December 23) Vidomosti Verkhovnoyi Rady Ukrayiny, 7, 36. URL : https://zakon.rada.gov.ua/laws/show/3689-12 [in Ukrainian].
8 Law of Ukraine On protecting from the unfair competition No. 236/96-VR (1996, June 07 ) Vidomosti Verkhovnoyi Rady Ukrayiny, 36, 164. URL: https://zakon.rada.gov.ua/laws/show/236/96-вр [in Ukrainian].
9 Boshytsʹkyy YU.L. (2016) Current directions of WIPO’s cooperation with the authorities in Ukraine in the field of intellectual property // Modern challenges and current problems of intellectual property law in Ukraine and Europe: zbirnyk materialiv Mizhnarodnoyi naukovo-praktychnoyi konferentsiyi 25-26.10.2016/NAN Ukrayiny; Kyyivsʹkyy universytet prava; redkol. YU.L. Boshytsʹkyy, F.Hari, M. Shvantner ta in./Lʹviv.Halytsʹka vydavnycha spilka. 2016. c.10-15/ URL: : http://kul.kiev.ua/perelik-prac/spisok-naukovih-prac-kandidata-juridichnih-nauk-profesora-boshickogo-jurija-ladislavovicha.html[in Ukrainian].
10 Kuzʹmych I.I. (2020) Legal status of classification mutation of biomedintellectproduct. Chasopys Kyyivsʹkoho universytetu prava. 2020, 2. c. 322 – 330/ URL: http://kul.kiev.ua//images//A/Chasopis/CHAS20__2.pdf [in Ukrainian].
11 Olefir A.O. (2015) To the problem of legal protection of biotechnologies. Theory and practice of intellectual property: nauk.-prakt. zhurn./ N.- d. in-t intelektualʹnoyi vlasnosti Nats. Akad. Prav. Nauk Ukrayiny. ISSN 2308-0361. Kyyiv, 2015, 1, c. 71 – 83/ URL: http://nbuv.gov.ua/UJRN/Tpiv_2015_1_10. [in Ukrainian].
12 Instruction ST-N MOH 42-4.0: 2016 Medicines. Good manufacturing practice, approved by the Order of the Ministry of Health of Ukraine dated July 29, 2016 № 798/ URL: http://aipm.org.ua/wp-content/uploads/2016/08/GMP_42-4.0_2016.pdf [in Ukrainian].
13 Regulations on the Ministry of Health of Ukraine, approved by the Resolution of the Cabinet of Ministers of Ukraine of March 25, 2015 №267/ URL: https://zakon.rada.gov.ua/laws/show/267-2015-п[in Ukrainian].
14 The Rules Governing Medicinal Products in the European Union. Volume 4. EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use / Pravyla, shcho rehulyuyutʹ likarsʹki zasoby v Yevropeysʹkomu Soyuzi. Tom 4. Yevropeysʹki pravyla z nalezhnoyi vyrobnychoyi praktyky likarsʹkykh zasobiv dlya lyudyny ta zastosuvannya u veterynariyi/ URL: https://ec.europa.eu/health/documents/eudralex/vol-4_en [in English].
15 Law of Ukraine On Amendments to Certain Laws of Ukraine Aimed at Increasing the Availability of Medicines, Medical Devices and Auxiliaries Purchased by a Person Authorized for Procurement in the Field of Health Care of March 17, 2020 for № 531-IX / effective from 18.03.2020. / Vidomosti Verkhovnoyi Rady Ukrayiny (VRU), 2020, №16, p.101/URL: https://zakon.rada.gov.ua/laws/show/531-20#Text [in Ukrainian].
16 Order of the Ministry of Education and Science of Ukraine On approval of the Rules for drawing up and submitting an application for an invention and an application for a utility model 22.01.2001 №22 registration Ministry of Justice of Ukraine 27.02.2001 №173 / 5364 document z0173-01/ URL: https://zakon.rada.gov.ua/laws/show/z0173-01[in Ukrainian].
17 Law of Ukraine On Amendments to Certain Legislative Acts of Ukraine Concerning the Reform of Patent Legislation dated 21.07.2020 for № 816-IX / effective from 16.08.2020/ URL: https://zakon.rada.gov.ua/laws/show/816-20#Text [in Ukrainian].
18 General principles of preclinical and clinical studies of biologically similar drugs that contain as an active substance proteins obtained by biotechnology / Metodychni rekomendatsiyi/ Ukrayinsʹkyy tsentr naukovoyi medychnoyi informatsiyi ta patentno - litsenziynoyi roboty DP Derzhavnyy ekspertnyy tsentr Ministerstva okhorony zdorov’ya Ukrayiny/ uz·hodzheno Upravlinnyam likarsʹkykh zasobiv ta medychnoyi produktsiyi MOZ Ukrayiny 25.09.2012/ URL: https://www.dec.gov.ua/materials/metodichni-rekomendaczi-shhodo-provedennya-doklinichnih-ta-klinichnih-viprobuvan/ [in Ukrainian].
19 Litvinova O.V. (2015) Features of biosimilars as an object of intellectual property // O.V.Litvinova//Farmatsevtychnyy zhurnal / 2015, 3, c.93-98/ URL: https://nuph.edu.ua/wp-content/uploads/2015/06/Диссертация-Литвиновадодатки-.pdf [in Ukrainian].
20 Havryley L.M. (2018) Microorganisms as objects of the invention /informatsiya dlya fakhivtsiv u haluzi biotekhnolohiyi/ 19.08.2018/ Yurydychnyy portal Protokol/ URL: https://protocol.ua/ua/mikroorganizmi_yak_ob_ekti_vinahodu_(informatsiya_dlya_fahivtsiv_u_galuzi_biotehnologii)/[in Ukrainian].
21 DIRECTIVE 2001/83/EC. (2001, November 28). Community code relating to medicinal products for human use. Yevropeys`kyy Parlament i Rada YeS. OJ L 311, 67. URL:https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf [in English].
Published
2020-11-10
How to Cite
Kuzmych, I. (2020). Legislative convergence on patenting of intellectual property on biotechnology. Law Review of Kyiv University of Law, 1(3), 259-264. Retrieved from https://chasprava.com.ua/index.php/journal/article/view/509
Section
Intellectual property law issues