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<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 2 \/ 2024<\/p>\n\n\n\n
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744<\/p>\n\n\n\n
![\"\"](\"https:\/\/test.inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153.png\"){kind=icon}
PDF (Ukrainian)<\/a><\/div>\n<\/div>\n\n\n\nDOI: https:\/\/doi.org\/10.33731\/22024.305481<\/a><\/p>\n\n\n\n Submitted 2024-03-17 <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Some aspects of ensuring a supplementary protection of medicinal products in Ukraine<\/strong><\/p>\n\n\n\n Vladyslav Zhuravlov<\/strong> <\/p>\n\n\n\n Abstract This article embarks on an in-depth exploration of the legal aspects surrounding the extension of intellectual property rights’ duration for inventions related to medicinal products.<\/p>\n\n\n\n Drawing upon international and domestic experiences, it scrutinizes the pertinent legal aspects and concludes that Ukraine grapples with significant ambiguity in ensuring supplementary protection for such products. Despite recent amendments to national legislation, the transitional regulatory framework falls short in delineating applicable mechanisms, thereby posing obstacles to effectively safeguarding the rights of patent holders. This ambiguity not only hinders pharmaceutical companies but also significantly influences the quality and accessibility of medicines for Ukrainian consumers.<\/p>\n\n\n\n By analyzing various legal mechanisms and their implementation, the article seeks to shed light on areas requiring clarity and propose viable strategies for enhancing intellectual property protection within the pharmaceutical domain.<\/p>\n\n\n\n Ultimately, this research aims to contribute to the ongoing discourse on intellectual property rights extension, offering insights into the Ukrainian context while advocating for robust legal frameworks that reconcile the interests of innovators and the public alike. The resolution of this problem is paramount for nurturing a conducive environment for pharmaceutical advancement, ensuring that novel and life-saving medications are developed and accessible to those in need.<\/p>\n\n\n\n Keywords: <\/strong>medicinal product, supplementary protection, patent, Supplementary Protection Certificate<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n \u0410\u043d\u0434\u0440\u043e\u0449\u0443\u043a \u0413., \u0420\u0430\u0431\u043e\u0442\u044f\u0433\u043e\u0432\u0430 \u041b. \u041f\u0440\u043e\u0431\u043b\u0435\u043c\u0438 \u043f\u0430\u0442\u0435\u043d\u0442\u0443\u0432\u0430\u043d\u043d\u044f \u0432\u0438\u043d\u0430\u0445\u043e\u0434\u0456\u0432 \u0443 \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u0456\u0439 \u0433\u0430\u043b\u0443\u0437\u0456: \u0435\u043a\u043e\u043d\u043e\u043c\u0456\u043a\u043e-\u043f\u0440\u0430\u0432\u043e\u0432\u0438\u0439 \u0430\u0441\u043f\u0435\u043a\u0442 (\u0427\u0430\u0441\u0442\u0438\u043d\u0430 \u0406). \u041d\u0430\u0443\u043a\u0430, \u0442\u0435\u0445\u043d\u043e\u043b\u043e\u0433\u0456\u0457, \u0456\u043d\u043d\u043e\u0432\u0430\u0446\u0456\u0457. 2018. \u2116 4. \u0421. 58\u221267.<\/p>\n\n\n\n Drug Price Competition and Patent Term Restoration Act of 1984. Patent Act (Act No. 121 of 1959). Council Regulation (EEC) No 1768\/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products. Act revising Article 63 of the Convention on the Convention on the Grant of European Patents (European Patent Convention) of 5 October 1973. Regulation (EC) No 1901\/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768\/92. Regulation (EC) No 469\/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (Codified version). COMMISSION STAFF WORKING DOCUMENT EVALUATION of the Regulation (EC) No 469\/2009 of the European Parliament and of the Council concerning the supplementary protection certificate for medicinal products, and Regulation (EC) No 1610\/96 of the European Parliament and of the Council concerning the creation of a supplementary protection certificate for plant protection products. Revision of the Supplementary Protection Certificate Regulations for medicinal and plant protection products. Judgment of the Court (Grand Chamber) of 25 July 2018, Teva UK Ltd and Others v Gilead Sciences Inc (C-121\/17, EU:C:2018:585). Judgment of the Court (Grand Chamber) of 30 April 2020, Royalty Pharma Collection Trust v Deutsches Patent- und Markenamt (C-650\/17, ECLI:EU:C:2020:327). Judgment of the Court (Fourth Chamber) of 21 March 2019, Abraxis Bioscience LLC v Comptroller General of Patents (C-443\/17, ECLI:EU:C:2019:238). Judgment of the Court (Grand Chamber) of 9 July 2020, Santen SAS v Directeur g\u00e9n\u00e9ral de l\u2019Institut national de la propri\u00e9t\u00e9 industrielle (C-673\/18, ECLI:EU:C:2020:531). Merck Sharp & Dohme, Case C-149\/22. Teva and Teva Finland, Case C-119\/22. \u041f\u0440\u043e \u043e\u0445\u043e\u0440\u043e\u043d\u0443 \u043f\u0440\u0430\u0432 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u043e\u0434\u0438 \u0456 \u043a\u043e\u0440\u0438\u0441\u043d\u0456 \u043c\u043e\u0434\u0435\u043b\u0456 : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 15 \u0433\u0440\u0443\u0434\u043d\u044f 1993 \u0440\u043e\u043a\u0443 \u2116 3687-XII. \u0412\u0456\u0434\u043e\u043c\u043e\u0441\u0442\u0456 \u0412\u0435\u0440\u0445\u043e\u0432\u043d\u043e\u0457 \u0420\u0430\u0434\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438. 1994. \u2116 7. \u0421\u0442. 32.<\/p>\n\n\n\n \u0406\u043d\u0441\u0442\u0440\u0443\u043a\u0446\u0456\u044f \u043f\u0440\u043e \u043f\u043e\u0440\u044f\u0434\u043e\u043a \u043f\u0440\u043e\u0434\u043e\u0432\u0436\u0435\u043d\u043d\u044f \u0441\u0442\u0440\u043e\u043a\u0443 \u0434\u0456\u0457 \u043f\u0430\u0442\u0435\u043d\u0442\u0443 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u0456\u0434, \u043e\u0431\u2019\u0454\u043a\u0442\u043e\u043c \u044f\u043a\u043e\u0433\u043e \u0454 \u0437\u0430\u0441\u0456\u0431, \u0432\u0438\u043a\u043e\u0440\u0438\u0441\u0442\u0430\u043d\u043d\u044f \u044f\u043a\u043e\u0433\u043e \u043f\u043e\u0442\u0440\u0435\u0431\u0443\u0454 \u0434\u043e\u0437\u0432\u043e\u043b\u0443 \u043a\u043e\u043c\u043f\u0435\u0442\u0435\u043d\u0442\u043d\u043e\u0433\u043e \u043e\u0440\u0433\u0430\u043d\u0443, \u0437\u0430\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u0430 \u041c\u0456\u043d\u0456\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u043e\u043c \u043e\u0441\u0432\u0456\u0442\u0438 \u0456 \u043d\u0430\u0443\u043a\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 13 \u0442\u0440\u0430\u0432\u043d\u044f 2002 \u0440\u043e\u043a\u0443 \u2116 298. \u0423\u0433\u043e\u0434\u0430 \u043f\u0440\u043e \u0430\u0441\u043e\u0446\u0456\u0430\u0446\u0456\u044e \u043c\u0456\u0436 \u0423\u043a\u0440\u0430\u0457\u043d\u043e\u044e, \u0437 \u043e\u0434\u043d\u0456\u0454\u0457 \u0441\u0442\u043e\u0440\u043e\u043d\u0438, \u0442\u0430 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0438\u043c \u0421\u043e\u044e\u0437\u043e\u043c, \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0438\u043c \u0441\u043f\u0456\u0432\u0442\u043e\u0432\u0430\u0440\u0438\u0441\u0442\u0432\u043e\u043c \u0437 \u0430\u0442\u043e\u043c\u043d\u043e\u0457 \u0435\u043d\u0435\u0440\u0433\u0456\u0457 \u0456 \u0457\u0445\u043d\u0456\u043c\u0438 \u0434\u0435\u0440\u0436\u0430\u0432\u0430\u043c\u0438-\u0447\u043b\u0435\u043d\u0430\u043c\u0438, \u0437 \u0456\u043d\u0448\u043e\u0457 \u0441\u0442\u043e\u0440\u043e\u043d\u0438. \u041f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0412\u0435\u0440\u0445\u043e\u0432\u043d\u043e\u0433\u043e \u0421\u0443\u0434\u0443 \u0443 \u0441\u043a\u043b\u0430\u0434\u0456 \u043a\u043e\u043b\u0435\u0433\u0456\u0457 \u0441\u0443\u0434\u0434\u0456\u0432 \u041a\u0430\u0441\u0430\u0446\u0456\u0439\u043d\u043e\u0433\u043e \u0433\u043e\u0441\u043f\u043e\u0434\u0430\u0440\u0441\u044c\u043a\u043e\u0433\u043e \u0441\u0443\u0434\u0443 \u0432\u0456\u0434 14 \u0433\u0440\u0443\u0434\u043d\u044f 2023 \u0440\u043e\u043a\u0443 \u0443 \u0441\u043f\u0440\u0430\u0432\u0456 \u2116 910\/8295\/21. \u041f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0412\u0435\u0440\u0445\u043e\u0432\u043d\u043e\u0433\u043e \u0421\u0443\u0434\u0443 \u0443 \u0441\u043a\u043b\u0430\u0434\u0456 \u043a\u043e\u043b\u0435\u0433\u0456\u0457 \u0441\u0443\u0434\u0434\u0456\u0432 \u041a\u0430\u0441\u0430\u0446\u0456\u0439\u043d\u043e\u0433\u043e \u0433\u043e\u0441\u043f\u043e\u0434\u0430\u0440\u0441\u044c\u043a\u043e\u0433\u043e \u0441\u0443\u0434\u0443 \u0432\u0456\u0434 04 \u043b\u0438\u043f\u043d\u044f 2019 \u0440\u043e\u043a\u0443 \u0443 \u0441\u043f\u0440\u0430\u0432\u0456 \u2116 910\/4947\/18. \u041f\u043e\u0441\u0442\u0430\u043d\u043e\u0432\u0430 \u0412\u0435\u0440\u0445\u043e\u0432\u043d\u043e\u0433\u043e \u0421\u0443\u0434\u0443 \u0443 \u0441\u043a\u043b\u0430\u0434\u0456 \u043a\u043e\u043b\u0435\u0433\u0456\u0457 \u0441\u0443\u0434\u0434\u0456\u0432 \u0414\u0440\u0443\u0433\u043e\u0457 \u0441\u0443\u0434\u043e\u0432\u043e\u0457 \u043f\u0430\u043b\u0430\u0442\u0438 \u041a\u0430\u0441\u0430\u0446\u0456\u0439\u043d\u043e\u0433\u043e \u0446\u0438\u0432\u0456\u043b\u044c\u043d\u043e\u0433\u043e \u0441\u0443\u0434\u0443 \u0432\u0456\u0434 24 \u043b\u044e\u0442\u043e\u0433\u043e 2020 \u0440\u043e\u043a\u0443 \u0443 \u0441\u043f\u0440\u0430\u0432\u0456 \u2116 760\/12081\/17. \u0420\u0456\u0448\u0435\u043d\u043d\u044f \u0413\u043e\u0441\u043f\u043e\u0434\u0430\u0440\u0441\u044c\u043a\u043e\u0433\u043e \u0441\u0443\u0434\u0443 \u043c\u0456\u0441\u0442\u0430 \u041a\u0438\u0454\u0432\u0430 \u0432\u0456\u0434 28 \u0432\u0435\u0440\u0435\u0441 \u043d\u044f 2022 \u0440\u043e\u043a\u0443 \u0443 \u0441\u043f\u0440\u0430\u0432\u0456 \u2116 910\/17245\/21. \u0427\u0430\u0439\u043a\u043e\u0432\u0441\u044c\u043a\u0430 \u0412. \u041f\u0440\u043e \u043f\u0440\u044f\u043c\u0443 \u0434\u0456\u044e \u0423\u0433\u043e\u0434\u0438 \u043f\u0440\u043e \u0430\u0441\u043e\u0446\u0456\u0430\u0446\u0456\u044e \u043c\u0456\u0436 \u0423\u043a\u0440\u0430\u0457\u043d\u043e\u044e \u0442\u0430 \u0404\u0432\u0440\u043e\u043f\u0435\u0439\u0441\u044c\u043a\u0438\u043c \u0421\u043e\u044e\u0437\u043e\u043c \u0443 \u043f\u0440\u0430\u0432\u043e\u0432\u0456\u0439 \u0441\u0438\u0441\u0442\u0435\u043c\u0456 \u0423\u043a\u0440\u0430\u0457\u043d\u0438. Jurnalul juridic national: teorie \u015fi practic\u0103. 2015. \u2116 3\/2 (13). P. 109\u2212113.<\/p>\n\n\n\n \u041f\u0440\u043e \u043c\u0456\u0436\u043d\u0430\u0440\u043e\u0434\u043d\u0456 \u0434\u043e\u0433\u043e\u0432\u043e\u0440\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 : \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 29 \u0447\u0435\u0440\u0432\u043d\u044f 2004 \u0440\u043e\u043a\u0443 \u2116 1906-IV. \u0412\u0456\u0434\u043e\u043c\u043e\u0441\u0442\u0456 \u0412\u0435\u0440\u0445\u043e\u0432\u043d\u043e\u0457 \u0420\u0430\u0434\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438. 2004. \u2116 50. \u0421\u0442. 540.<\/p>\n\n\n\n \u041a\u0430\u043f\u0456\u0446\u0430 \u042e. \u0421\u0435\u0440\u0442\u0438\u0444\u0456\u043a\u0430\u0442 \u0434\u043e\u0434\u0430\u0442\u043a\u043e\u0432\u043e\u0457 \u043e\u0445\u043e\u0440\u043e\u043d\u0438 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0404\u0421 \u0442\u0430 \u043f\u0440\u043e\u0434\u043e\u0432\u0436\u0435\u043d\u043d\u044f \u0441\u0442\u0440\u043e\u043a\u0443 \u0447\u0438\u043d\u043d\u043e\u0441\u0442\u0456 \u043f\u0430\u0442\u0435\u043d\u0442\u0443 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u0456\u0434 \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456. \u0422\u0435\u043e\u0440\u0456\u044f \u0456 \u043f\u0440\u0430\u043a\u0442\u0438\u043a\u0430 \u0456\u043d\u0442\u0435\u043b\u0435\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u043e\u0457 \u0432\u043b\u0430\u0441\u043d\u043e\u0441\u0442\u0456. 2016. \u2116 5. \u0421. 49\u221257.<\/p>\n\n\n\n \u0416\u0443\u0440\u0430\u0432\u043b\u044c\u043e\u0432 \u0412. \u041f\u0440\u043e\u0431\u043b\u0435\u043c\u043d\u0456 \u0430\u0441\u043f\u0435\u043a\u0442\u0438 \u0437\u0430\u0431\u0435\u0437\u043f\u0435\u0447\u0435\u043d\u043d\u044f \u0434\u043e\u0434\u0430\u0442\u043a\u043e\u0432\u043e\u0433\u043e \u043f\u0435\u0440\u0456\u043e\u0434\u0443 \u043e\u0445\u043e\u0440\u043e\u043d\u0438 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0438\u0445 \u0437\u0430\u0441\u043e\u0431\u0456\u0432 \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456 (2024). Theory and practice of intellectual property\u2116 2 \/ 2024 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/22024.305481 Submitted 2024-03-17Accepted 2024-03-25Published 2024-06-04 Some aspects of ensuring a supplementary protection of medicinal products in Ukraine Vladyslav Zhuravlovapplicant for the second (master’s) level of higher education in the specialty 081 “Law” of the educational and scientific […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-8066","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8066","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/comments?post=8066"}],"version-history":[{"count":4,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8066\/revisions"}],"predecessor-version":[{"id":8419,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8066\/revisions\/8419"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=8066"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Accepted 2024-03-25
Published 2024-06-04<\/p>\n\n\n\n![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
<\/figure>\n\n\n\n
applicant for the second (master’s) level of higher education in the specialty 081 “Law” of the educational and scientific program “Intellectual Property” of the Educational and Research Institute of Law of Taras Shevchenko National University of Kyiv
Ukraine
https:\/\/orcid.org\/0009-0003-3137-3053<\/a><\/p>\n\n\n\n
<\/strong>The critical role of intellectual property in fostering innovation, especially within the pharmaceutical industry, cannot be overstated. In the era where groundbreaking inventions often require substantial financial commitments, the supplementary protection of medicinal products emerges as a vital incentive for further research and safeguarding patent holders’ interests. Despite the pivotal function of these legal provisions, the contemporary legal framework appears ill-equipped to navigate the evolving challenges, necessitating a thorough examination and identification of optimal solutions.<\/p>\n\n\n\n
https:\/\/www.govinfo.gov\/content\/pkg\/STATUTE-98\/pdf\/STATUTE-98-Pg1585.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.cas.go.jp\/jp\/seisaku\/hourei\/ data\/PA.pdf<\/a><\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/EN\/ALL\/?uri=CELEX%3A31992R1768<\/a><\/p>\n\n\n\n
https:\/\/www.epo.org\/en\/legal\/official-journal\/1992\/01-02\/p1.html<\/a><\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32006R1901<\/a><\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX% 3A32009R0469<\/a><\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX%3A52020SC0292#PP4Contents <\/a><\/p>\n\n\n\n
https:\/\/www.europarl.europa.eu\/RegData\/etudes\/ BRIE\/2023\/740258\/EPRS_BRI(2023)740258_EN.pdf<\/a><\/p>\n\n\n\n
https:\/\/curia.europa.eu\/juris\/document\/document.jsf;jsessionid=6124E8432D06DC4855A0EC53FF833D6F?text=&docid=204388&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=335791511<\/a><\/p>\n\n\n\n
https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&docid=225984&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=3358061<\/a><\/p>\n\n\n\n
https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&docid=212011&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=3358116<\/a><\/p>\n\n\n\n
https:\/\/curia.europa.eu\/juris\/document\/document.jsf?text=&docid=228371&pageIndex=0&doclang=EN&mode=lst&dir=&occ=first&part=1&cid=3358162<\/a><\/p>\n\n\n\n
https:\/\/curia.europa.eu\/juris\/ liste.jsf?language=en&td=ALL&num=C-149\/22<\/a><\/p>\n\n\n\n
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https:\/\/zakon.rada.gov.ua\/laws\/show\/z0453-02<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/984_011<\/a><\/p>\n\n\n\n
https:\/\/reyestr.court.gov.ua\/Review\/115821573<\/a><\/p>\n\n\n\n
https:\/\/reyestr.court.gov.ua\/Review\/82858256<\/a><\/p>\n\n\n\n
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https:\/\/reyestr.court.gov.ua\/Review\/106889921<\/a><\/p>\n\n\n\n
https:\/\/polikarpov.legal\/aspekti-zabezpechennya-likarskih-zasobiv-v-ukrayini\/<\/a><\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"