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2023 | OriginalPaper | Chapter

The Patentability of Biotechnological Inventions in the EU: The Ukrainian Context

Author : Tetyana Komarova

Published in: Competition and Intellectual Property Law in Ukraine

Publisher: Springer Berlin Heidelberg

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Abstract

The problems of bioengineering development and the use of its results in medicine have become extremely important due to the powerful development of modern technologies and their capabilities. At the same time, this issue cannot be attributed purely to the field of medicine, as it is also closely related to the ethical, social, economic and, of course, legal spheres. If we talk about the legal side of the issue, it is impossible not to touch on the topic of patenting the results of bioengineering. Patenting the results of bioengineering has begun to form a new vector in scientific research. If earlier the scientific study of cells of organisms, including human ones, was based on openness and access of the whole scientific community to its course and results, now it has become a commercialised and monetised domain. The difficulty in understanding this issue is compounded by the fact that the use of living cells in research remains an area in which there is no consensus among states. This chapter aims to identify the spheres in which it is forbidden to patent the results of medical research and as a consequence there is no legal protection of biotechnological inventions. It focuses on Ukrainian and European legislation and their comparison because Ukraine must study the European experience and practice of patenting the results of bioengineering, as the Association Agreement makes European standards in this area part of its legal system. Moreover, the chapter outlines some trends in the development of legal regulation of bioengineering. All these questions are important in the light of the development of the Ukrainian market for biotechnological developments (according to the Annual Report of the National Intellectual Property Office of Ukraine, in the period 2016–2020 1208 applications for inventions in the field of “biotechnology” were submitted).

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previous chapter Patent Law and Access to Medicines in Ukraine

next chapter The Reformed Design Law in Ukraine: What is Right with EU Trade Agreements?

For details on the Association Agreement and approximation in the field of IP, see Roman Petrov, ‘The EU–Ukraine Association Agreement as a General Framework of Contemporary EU–Ukraine Relations’ and Yuriy Kapitsa, ‘Association Agreements and Problems Approximating Intellectual Property Legislation of Third Countries with the EU Acquis: The Case of Ukraine’ in this Volume.

For example, Bulgaria, Croatia, Hungary, Romania, Montenegro.

See also Zvenyslava Opeida, ‘Competition and International Trade: Complementing Trade Defense Policy with Effective Competition Policy in Ukraine’ in this Volume.

Agreement on Trade-related Aspects of Intellectual Property Rights 1994, art 7.

Partnership and Cooperation Agreement between the European Communities and their Member States, of the one part, and Ukraine, of the other part (1998) OJ L49/3 (Partnership and Cooperation Agreement), art 50.

Art 50 concerned: Berne Convention for the Protection of Literary and Artistic Works 1971; Rome Convention for the Protection of Performers, Producers of Phonograms and Broadcasting Organizations 1961; Protocol Relating to the Madrid Agreement Concerning the International Registration of Marks 1989; Nice Agreement concerning the International Classification of Goods and Services for the Purposes of the Registration of Marks 1977, amended 1979; Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedures 1977, modified in 1980; International Convention for the Protection of New Varieties of Plants 1978.

Regarding the adaptation of Ukrainian legislation to international standards of that time, see Yuriy Kapitsa, ‘Status and Directions of Adaptation of Ukrainian Legislation in the Field of Intellectual Property Protection to EU legislation’ (2005) 1 Law of Ukraine 66–70; Doris Long et al., Protection of Intellectual Property Rights: Norms of International and National Law and Their Law Enforcement – A Practical Guide (“K.I.S.” 2007).

Interim Agreement on Trade and Trade-related Matters between the European Community, the European Coal and Steel Community and the European Atomic Energy Community, of the one party, and Ukraine, of the other part (1995) OJ L311(Interim Agreement on Trade and Trade-related Matters), Annex III, art 18.

For Ukraine’s progress in implementing the Association Agreement, see https://pulse.kmu.gov.ua accessed 26 October 2022. For the stage of progress in the implementation of the Association Agreement in the part related to intellectual property, see https://pulse.kmu.gov.ua/ua/direction/intelektualna-vlasnist accessed 26 October 2022.

It is a question of large-scale application by the Supreme Court of the primacy of the Association Agreement over the Ukrainian legislation, which was first applied in the Ukrainian Supreme Court, Decision No. 910/14972/17 Zentiva k.s. v. MEDT and Alliance of Beauty (2018), which concerns Association Agreement, art 198. Concerning Europeanisation of Ukrainian judiciaries, see Roman Petrov and Paul Kalinichenko, ‘The Europeanization of Third Country Judiciaries Through the Application of the EU Acquis: The Cases of Russia and Ukraine’ (2011) 60(2) International and Comparative Law Quarterly 325. See also Roman Petrov, ‘The EU–Ukraine Association Agreement as a General Framework of Contemporary EU–Ukraine Relations’ and Yuriy Kapitsa, ‘Association Agreements and Problems Approximating Intellectual Property Legislation of Third Countries with the EU Acquis: The Case of Ukraine’ in this Volume.

Association Agreement, Geographical Indications–Legislation of the Parties and Elements for Registration and Control, Annex XXVII-A to Chapter 9 Title IV; See also Anastasiia Kyrylenko, ‘Why so Few Geographical Indications in Ukraine? Legal, Political and Socio-Economic Perspective’ in this Volume.

Association Agreement, Energy Cooperation, Including Nuclear Issues, Annex XXVII-B to Chapter 1 Title V.

Association Agreement, Energy Cooperation, Including Nuclear Issues, Annex XXVII-A to Chapter 1 Title V.

On the Association Agreement and competition law, see Kseniia Smyrnova, ‘The “Europeanization” of Competition Law in Ukraine’ in this Volume.

For example, concerning new Unitary Patent System.

See also Yuriy Kapitsa, ‘Association Agreements and Problems Approximating Intellectual Property Legislation of Third Countries with the EU Acquis: The Case of Ukraine’ in this Volume.

See Marc Maresceau, ‘Turkey: A Candidate State Destined to Join the Union’, in Nic Niamh Shuibhne and Laurence W Gormley (eds), From Single Market to Economic Union. Essays in Honour of John A Usher (Oxford University Press, 2012) 315 (323).

Yuriy Kapitsa, ‘Conducting Comparative Studies of the Law of Ukraine and the European Union: Questions of Methodology’ (2006) 9 Bulletin of the Ministry of Justice of Ukraine 56.

Pavlo Tsybulov, Fundamentals of Intellectual Property (Institute of Intellectual Property and Law 2002) 52. Also see: Lubov Fedulova and Ludmila Tsybuldka, ‘Trends in the Formation of the Latest Technological Structure in the World Economy: The Role of Intellectual Property Management’ (2011) 12 Ukraine Economy 23 (24).

Association Agreement, art 221(3).

Association Agreement, art 221(4).

Association Agreement, art 221(5).

On the transposition of the European Union into the legal systems of third countries, see Roman Petrov, Transposition of the European Union Acquis into the Legal Systems of the Third Countries (Istina 2012). On the legislative methodology of approximation, see Yuriy Kapitsa, ‘Association Agreements and Problems Approximating Intellectual Property Legislation of Third Countries with the EU Acquis: The Case of Ukraine’ in this Volume.

See Vyktor Muravyov, ‘Extraterritorial Action of European Union Law in the Legal Systems of Third Countries and Association Agreements’ (2013) 117(1) Current Issues of International Relations 61–73; Ludmyla Falalieieva, ‘Human Rights and Extraterritorial Application of the EU Law: Evolution of Jurisdictional Models Application Practice’ (2017) 1(46) Journal of International Relations of KNU 91–98.

ECJ C-214/94 Ingrid Boukhalfa v. Bundesrepublik Deutschland (1996) EU:C:1996:174.

On the role of the Court Justice of the EU in the interpretation and development of EU law, see Tetyana Komarova, Court of Justice of the European Union: Development of the Judicial System and Practice of Interpretation of EU Law: Monograph (Law 2018).

Yuriy Kapitsa, European Union Intellectual Property Law: Formulation, Institutes, Directions of Development (Academperiodyka 2017) 445.

Ibid 466.

Parliament and Council Directive 98/44/EC of 6 July 1998 on the Legal Protection of Biotechnological Inventions (1998) OJ L213/13, 13–21.

For the discussion of the society and scientists concerning legal protection of biotechnology, see Jens Hillebrand, ‘Legal Protection of Biotechnological Inventions: Preconditions, Content, Scope and Prospects for the Future’ (2003) 3 Intellectual Property 42; Yuriy Kapitsa and Кarina Shakhbazian, ‘Protection of the Rights to Inventions in the Field of Biotechnology in the European Union and Under the Legislation of Ukraine’ (2005) 1(26) Theory and Practice of Intellectual Property 19.

Yan Min, ‘Morality—An Equivocal Area in the Patent System’ (2012) 34(4) European Intellectual Property Review 261 (263).

Implementing Regulations to the European Patent Convention, rules 28–29.

ECJ C-377/98 Kingdom of the Netherlands v. European Parliament and Council of the European Union (2001) EU:C:2001:523.

ECJ C-34/10 Oliver Brüstle v. Greenpeace eV. (2011) EU:C:2011:669.

ECtHR H v Norway 17,004/90 (1992); ECtHR Vo v France 53,924/00 (2004); ECtHR Evans v United Kingdom 6339/05 (2006). See Richard M Schwartz and Timo Minssen, ‘Life After Myriad: The Uncertain Future of Patenting Biomedical Innovation and Personalised Medicine in an International Context’ (2015) 3 Intellectual Property Quarterly 189; An Baeyens and Tom Goffin, ‘European Court of Justice: ECJ 2015/2, International Stem Cell Corp v. Comptroller General of Patents, Designs and Trade Marks, Case C-364/13’ (2015) 22 (2) European Journal of Health Law 141.

See Katerina Sideri, Bioproperty, Biomedicine and Deliberative Governance: Patents as Discourse on Life (Routledge 2014) 79, 80; Austin Smith, ‘No to Ban on Stem-Cell Patents’ (2011) 472(7344) Nature 418.

See Andrea Faeh, ‘Judicial Activism, the Biotech Directive and its Institutional Implications – is the CJEU Acting as a Legislator or a Court when Defining the ‘‘Human Embryo’’?’ (2015) 4 European Law Review 613.

See Alice Yuen-Ting Wong and Aurdlie Mahalatchimy, ‘Human Stem Cells Patents – Emerging Issues and Challenges in Europe, United States, China, and Japan’ (2018) 21(5–6) The Journal of World Intellectual Property 326.

Anna Nordberg and Timo Minssen, ‘A ‘Ray of Hope’ for European Stem Cell Patents or ‘Out of the Smog into the Fog’?: An Analysis of Recent European Case Law and How It Compares to the US’ (2016) 47(2) International Review of Intellectual Property and Competition Law 138 (160).

ECJ C-364/13 International Stem Cell Corporation v. Comptroller General of Patents, Designs and Trade Mark (2012) EU:C:2014:2451, para 28.

See Fruzsina Molnár-Gábor, ‘Science, Ethics, and Patents: Ethically-motivated Barriers to the Patenting of the Results of Human Embryonic Stem Cell Research’ in Christine Hauskeller, Arne Manzeschke and Anja Pichl (eds), The Matrix of Stem Cell Research: An Approach of Rethinking Science in Society (Routledge 2019) 50–67; Enrico Bonadio, ‘Biotech Patents and Morality after Brüstle’ (2012) 34(10) European Intellectual Property Review 433; H P Brack, ‘Post Brüstle Developments in EU Biotech Patent Law at the CJEU’ (2016) 1(16) Epi Information.

Rob Aerts, ‘The Unitary Patent and the Biotechnology Directive: Is Uniform Protection of Biotechnological Inventions Ensured?’ (2014) 36(9) European Intellectual Property Review 584; Aisling McMahon, ‘An Institutional Examination of the Implications of the Unitary Patent Package for the Morality Provisions: A Fragmented Future Too Far?’ (2017) 48(1) International Review of Intellectual Property and Competition Law 42.

Constitution of Ukraine 1996, 254к/96-BP, art 141.

Civil Code of Ukraine 2003, 435-IV.

Ukrainian Law on Protection of Rights to Inventions and Utility Models 1993, 3687-XII.

Ukrainian Law on Protection of the Rights to Industrial Designs 1993, 3688-XII.

Ukrainian Law on Protection of Trademark Rights for Goods and Services 1993, 3689-XII.

Ukrainian Law on Protection from Unfair Competition 1996, 236/96-BP.

Ukraine traditionally maintains a two-tier system of legislation in the field of intellectual property law. It still continues legal tradition of placement of norms on intellectual property law in the system of civil law.

Ukrainian Law on Amendments to Certain Legislative Acts of Ukraine Concerning the Reform 2020, 816-IX.

Iryna Kuzmych, ‘Legislative Convergence on Patenting of Intellectual Property on Biotechnologies’ (2020) 3 Law Review of Kyiv University of Law 259 (259); Andryi Olefir ‘On the Issues of Legal Protections of Biotechnologies’ (2015) 1 The Theory and Practice of Intellectual Property 71(74) (the author analyzed contradictions which were not harmonized in 2020).

Olena Orliuk, ‘Intellectual Property in Ukraine: Experience, Legislation, Problems, Prospects’ (2011) 3 Law of Ukraine 20 (17); Katerina Horbachova, et al., ‘National Strategy for the Development of Intellectual Property in Ukraine in the Context of Ensuring Compliance with International Obligations’ (2020) 3 Legal Scientific Electronic Journal 88 (90).

See also Leonid Tarasenko, ‘Legislative Reforms on Patents, Utility Models and Industrial Designs in Ukraine’ in this Volume.

Resolution of the Cabinet of Ministers of Ukraine of 28 July 2003, No. 1174 on Approval of the State Program of Industrial Development for 2003–2011.

Order of the Ministry of Health of Ukraine of 26 October 1004, No. 521 “On approval of methodical guidelines ‘Medico-biological researches of production strains of microorganisms and toxicological and hygienic assessment of microbial drugs, determining their safety and justification of hygienic standards and regulations’”.

United Nations Convention on Biological Diversity 1993, art 2.

On the strategic directions of biotechnological sphere development of leading countries, see Tetyana Iukhnovska and Tetyana Gruzdova, ‘Strategic Directions for Development of the Biotechnology Sector in Some World Countries: Guidelines for Ukraine’ (2015) 2(53) Ukrainian Society 50.

Resolution of the Cabinet of Ministers of Ukraine of 3 March 2021, No. 179 on Approval of the National Economic Strategy for the Period up to 2030.

On details of the National IP Strategy of Ukraine, see Olena Orliuk, ‘Strategic Directions of the Intellectual Property Area Development in Ukraine’ in this Volume.

Olefir ‘On the Issues of Legal Protections of Biotechnologies’ (n 51) 71(73 and 74).

For a complex review of reform 2020, see Leonid Tarasenko, ‘Patent Legislation Reform (2020): Main Innovations of Inventions (Utility Models)’ (2021) 73 Visnyk of the Lviv University Series Law 67.

Association Agreement, art 221 (1).

See also Leonid Tarasenko, ‘Legislative Reforms on Patents, Utility Models and Industrial Designs in Ukraine’ in this Volume.

Under the changes of 2020 it is 20 years for the invention and 10 years for the utility model.

Oleksandr Slobodian, ‘Features of Patenting Biotechnological Inventions in the European Patent Office’ (2013) 1 Chronicles of Kyiv Institute of Law 225 (228).

Olena Ponomarova, ‘Experience of EU Countries on Ethical Aspects of Patenting Biotechnologies in the Field of Medicine and Pharmacy’ (2021) 2 Theory and Practice of Intellectual Property 23 (24).

See Janne Rothmar Herrmann and Malene Rowlandson, ‘The Role of Ethics and Morality in EU Law’ (2008) 5(6) Journal of International Biotechnology Law 241.

Association Agreement, art 221(5).

TRIPS, art 27, provides that members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.

Olha Poliakova and Viktoriia Shlykova, ‘The Patenting of Biotechnological Developments in Ukraine: Trends and Structure’ (2017) 2 The Problems of the Economy 124 (128).

Rob Aerts, ‘The Unitary Patent and the Biotechnology Directive: Is Uniform Protection of Biotechnological Inventions Ensured?’ (2014) 36(9) European Intellectual Property Review 584

An Baeyens and Tom Goffin, ‘European Court of Justice: ECJ 2015/2, International Stem Cell Corp v. Comptroller General of Patents, Designs and Trade Marks, Case C-364/13’ (2015) 22(2) European Journal of Health Law 141

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H P Brack, ‘Post Brüstle Developments in EU Biotech Patent Law at the CJEU’ (2016) 1(16) Epi Information 20

Andrea Faeh, ‘Judicial Activism, the Biotech Directive and its Institutional Implications—is the CJEU Acting as a Legislator or a Court when Defining the ‘‘Human Embryo’’?’ (2015) 4 European Law Review 613

Ludmyla Falalieieva, ‘Human Rights and Extraterritorial Application of the EU Law: Evolution of Jurisdictional Models Application Practice’ (2017) 1(46) Journal of International Relations of KNU 91 [Людмилa Фaлaлєeвa, ‘Пpaвa Людини тa Eкcтepитopiaльнa Дiя Пpaвa ЄC: Eвoлюцiя Пpaктики Зacтocyвaння Юpиcдикцiй’ (2017) 1(46) Bicник Miжнapoдниx Biднocин 91]

Lubov Fedulova and Ludmila Tsybuldka, ‘Trends in the Formation of the Latest Technological Structure in the World Economy: The Role of Intellectual Property Management’ (2011) 12 Ukraine Economy 23 [Любoв Фeдyлoвa тa Людмилa Цибyльcькa, ‘Teндeнцiï Cтaнoвлeння Hoвiтньoгo Texнoлoгiчнoгo Уклaдy y Cвiтoвiй Eкoнoмiцi: Poль Упpaвлiння Iнтeлeктyaльнoю Bлacнicтю’ (2011) 12 Eкoнoмiкa Укpaïни 23]

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Marc Maresceau, ‘Turkey: A Candidate State Destined to Join the Union’, in Nic Niamh Shuibhne and Laurence W Gormley (eds), From Single Market to Economic Union: Essays in Honour of John A Usher (Oxford University Press 2012)

Aisling McMahon, ‘An Institutional Examination of the Implications of the Unitary Patent Package for the Morality Provisions: A Fragmented Future Too Far?’ (2017) 48(1) International Review of Intellectual Property and Competition Law 42

Yan Min, ‘Morality—An Equivocal Area in the Patent System’ (2012) 34(4) European Intellectual Property Review 261

Fruzsina Molnár-Gábor, ‘Science, Ethics, and Patents: Ethically-motivated Barriers to the Patenting of the Results of Human Embryonic Stem Cell Research’ in Christine Hauskeller, Arne Manzeschke and Anja Pichl (eds), The Matrix of Stem Cell Research: An Approach of Rethinking Science in Society (Routledge 2019)

Vyktor Muravyov, ‘Extraterritorial Action of European Union Law in the Legal Systems of Third Countries and Association Agreements’ (2013) 117(1) Current Issues of International Relations 61 [Biктop Mypaвйoв, ‘Eкcтpaтepитopiaльнa Дiя Пpaвa Євpoпeйcькoгo Coюзy y Пpaвoпopядкax Tpeтix Кpaïн i Угoди пpo Acoцiaцiю’ (2013) 117(1) Aктyaльнi Пpoблeми Miжнapoдниx Biднocин 61]

Anna Nordberg and Timo Minssen, ‘A ‘Ray of Hope’ for European Stem Cell Patents or ‘Out of the Smog into the Fog’?: An Analysis of Recent European Case Law and How it Compares to the US’ (2016) 47(2) International Review of Intellectual Property and Competition Law 138

Andryi Olefir ‘On the Issues of Legal Protections of Biotechologies’ (2015) 1 The Theory and Practice of Intellectual Property 71 [Aндpiй Oлeфip, ‘Дo Пpoблeми Пpaвoвoї Oxopoни Бioтexнoлoгiй’ (2015) 1 Teopiя i Пpaктикa Iнтeлeктyaльнoï Bлacнocтi 71]

Olena Orliuk, ‘Intellectual Property in Ukraine: Experience, Legislation, Problems, Prospects’ (2011) 3 Law of Ukraine 20 [Oлeнa Opлюк, ‘Iнтeлeктyaльнa Bлacнicть в Укpaïнi: Дocвiд, Зaкoнoдaвcтвo, Пpoблeми, Пepcпeктиви” (2011) 3 Пpaвo Укpaïни 20]

Roman Petrov, Transposition of the European Union Acquis into the Legal Systems of the Third Countries (Istina 2012)

Roman Petrov and Paul Kalinichenko, ‘The Europeanization of Third Country Judiciaries Through the Application of the EU Acquis: The Cases of Russia and Ukraine’ (2011) 60(2) International and Comparative Law Quarterly 325

Olha Poliakova and Viktoriia Shlykova, ‘The Patenting of Biotechnological Developments in Ukraine: Trends and Structure’ (2017) 2 The Problems of the Economy 124 [Oльгa Пoлякoвa тa Biктopiя Шликoвa ‘Пaтeнтyвaння Бioтexнoлoгiчниx Poзpoбoк в Укpaïнi: Teндeнцiï тa Cтpyктypa’ (2017) 2 Пpoблeми Eкoнoмiки 124]

Olena Ponomarova, ‘Experience of EU Countries on Ethical Aspects of Patenting Biotechnologies in the Field of Medicine and Pharmacy’ (2021) 2 Theory and Practice of Intellectual Property 23 [Oлeнa Пoнoмapьoвa, ‘Дocвiд Кpaïн ЄC щoдo Eтичниx Acпeктiв Пaтeнтyвaння Бioтexнoлoгiй y Cфepi Meдицини i Фapмaцiï’ (2021) 2 Teopiя i Пpaктикa Iнтeлeктyaльнoï Bлacнocтi 23]

Janne Rothmar Herrmann and Malene Rowlandson, ‘The Role of Ethics and Morality in EU Law’ (2008) 5(6) Journal of International Biotechnology Law 241

Richard M Schwartz and Timo Minssen, ‘Life After Myriad: The Uncertain Future of Patenting Biomedical Innovation and Personalised Medicine in an International Context’ (2015) 3 Intellectual Property Quarterly 189

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Title: The Patentability of Biotechnological Inventions in the EU: The Ukrainian Context
Author: Tetyana Komarova
Publisher: Springer Berlin Heidelberg
Book: Competition and Intellectual Property Law in Ukraine
Print ISBN: 978-3-662-66100-0

Electronic ISBN: 978-3-662-66101-7

Copyright Year: 2023
DOI: https://doi.org/10.1007/978-3-662-66101-7_17