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<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 6 \/ 2021<\/p>\n\n\n\n
ISSN (Print) 2308-0361
ISSN (Online) 2519-2744<\/p>\n\n\n\n
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PDF (Ukrainian)<\/a><\/div>\n<\/div>\n\n\n\nDOI: https:\/\/doi.org\/10.33731\/62021.249108<\/a><\/p>\n\n\n\n Published \u00a0\u00a0\u00a0\u00a0\u00a02021-12-27<\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine<\/strong><\/p>\n\n\n\n Anastasiia Homeniuk<\/strong> <\/p>\n\n\n\n Abstract The author in details analyses European Union approaches to definition of the subject matter of the supplementary protection, providing criteria which are recommended to use in order to decide whether the product is covered by the basic patent in force. Also, the paper is focusing on the issues related to verification of data and materials provided together with the application for a certificate \u2014 such as whether the requirement that the medicinal product must be submitted for marketing authorization in Ukraine no later than during one year after it\u2019s first marketing authorization in the world, whether the authorization provided is the first authorization in Ukraine, etc.<\/p>\n\n\n\n Another problem which is highlighted in the study is the application of the rule to submit the petition for obtaining supplementary protection to those patents and marketing authorizations which were issued before the amendments to the Law came in force, as this question remained unresolved due to the lack of transitional provisions in the Law. Also author points out the necessity to align the provisions of the Article 271 of the Law of Ukraine \u00abOn Protection of Rights to Inventions and Utility Models\u00bb regarding the definition of the subject matter of supplementary protection in accodance with patent legislation by excluding application of the medicinal product from the list as it is not patentable according to Ukrainian law. In addition, the author emphasized the urge to adopt relevant bylaws (procedure) regulating the issue of certificates of supplementary protection.<\/p>\n\n\n\n Keywords: <\/strong>supplementary protection certificate, basic patent, procedure for obtaining supplementary protection certificate<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n European Commission, Explanatory Memorandum to the Proposal for a Council Regulation (EEC), of 11 April 1990, concerning the creation of a supplementary protection certificate for medicinal products (COM(90) 101 final \u2013 SYN255). Wenzel R. Analoge Anwendung der Verordnung \u00fcber das erg\u00e4nzende Schutzzertifikat f\u00fcrArzneimittel auf Medizinprodukte? \/ Robert Wenzel., 2017. 253 \u0441.<\/p>\n\n\n\n \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 15.12.1993\u2008\u0440. \u2116 3687-XII. Silverman A. The Relationship Between Basic and Improvement Patents [\u0415\u043b\u0435\u043a\u0442\u0440\u043e\u043d\u043d\u0438\u0439 \u0440\u0435\u0441\u0443\u0440\u0441] \/ Arnold B. Silverman \/\/ JOM, 47 (1) (1995), p. 50. 1995. Judgment of the Court (Fifth Chamber) of 16 September 1999. (Farmitalia Carlo Erba Srl.). Case C-392\/97.<\/p>\n\n\n\n Order of the Court (Eighth Chamber), 14 November 2013 (Glaxosmithkline Biologicals SA). Case C 210\/13.<\/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\u201356.<\/p>\n\n\n\n Judgment of the Court (Fourth Chamber) of 30 April 2020 (Royalty Pharma Collection Trust). Case C 650\/17.<\/p>\n\n\n\n Judgment of the Court (Third Chamber) of 12 December 2013 (Eli Lilly and Company Ltd). Case C 493\/12.<\/p>\n\n\n\n![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
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Ukraine
https:\/\/orcid.org\/0000-0002-6431-918X<\/a><\/p>\n\n\n\n
<\/strong>The article is devoted to the study of key issues of legal regulation of supplementary protection of inventions after the adoption of the Law of Ukraine \u00abOn Amendments to Certain Legislative Acts of Ukraine on Patent Legislation Reform\u00bb in the absence of bylaws to regulate the procedure for issuing supplementary protection certificates. The study also highlights the main shortcomings and gaps in the regulation of certain issues of application of supplementary protection certificates in the current Law of Ukraine \u00abOn protection of rights to inventions and utility models\u00bb.<\/p>\n\n\n\n
https:\/\/eur-lex.europa.eu\/legal-content\/en\/ALL\/?uri=CELEX%3A51990PC0101<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/3687-12\/ed20200816#Text<\/a><\/p>\n\n\n\n
https:\/\/www.tms.org\/pubs\/journals\/JOM\/matters\/matters-9501.html<\/a><\/p>\n\n\n\n