{"id":7538,"date":"2025-12-22T13:43:29","date_gmt":"2025-12-22T11:43:29","guid":{"rendered":"https:\/\/inprojournal.org\/?page_id=7538"},"modified":"2026-02-04T11:03:11","modified_gmt":"2026-02-04T09:03:11","slug":"2025-4-5","status":"publish","type":"page","link":"https:\/\/inprojournal.org\/en\/2025-4-5\/","title":{"rendered":"2025-4-5"},"content":{"rendered":"\n<p><\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-9d6595d7 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:33.33%\">\n<figure class=\"wp-block-image size-large is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"734\" height=\"1024\" src=\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg\" alt=\"\" class=\"wp-image-3609\" style=\"width:217px;height:302px\" srcset=\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg 734w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-215x300.jpg 215w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-768x1071.jpg 768w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-1101x1536.jpg 1101w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-1468x2048.jpg 1468w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-scaled.jpg 1835w\" sizes=\"auto, (max-width: 734px) 100vw, 734px\" \/><\/figure>\n\n\n\n<div style=\"height:26px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-small-font-size\">Theory and practice of intellectual property<br>\u2116 4 \/ 2025<\/p>\n\n\n\n<p class=\"has-small-font-size\">ISSN (Print) 2308-0361<br>ISSN (Online) 2519-2744<\/p>\n\n\n\n<div class=\"wp-block-buttons has-custom-font-size is-content-justification-left is-layout-flex wp-container-core-buttons-is-layout-fdcfc74e wp-block-buttons-is-layout-flex\" style=\"font-size:10px\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-black-color has-text-color has-custom-font-size wp-element-button\" href=\"https:\/\/drive.google.com\/file\/d\/1_H8i_lwgWx1CODXIntvwK3eCIMCdVhUz\/view\" style=\"border-radius:10px;font-size:10px\" target=\"_blank\" rel=\"noreferrer noopener\"><img loading=\"lazy\" decoding=\"async\" width=\"14\" height=\"14\" class=\"wp-image-362\" style=\"width: 14px;\" src=\"https:\/\/test.inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153.png\" alt=\"\" srcset=\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153.png 512w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153-300x300.png 300w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153-150x150.png 150w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153-450x450.png 450w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153-106x106.png 106w, https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/01\/free-icon-pdf-201153-80x80.png 80w\" sizes=\"auto, (max-width: 14px) 100vw, 14px\" \/> PDF (English)<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:26px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-small-font-size\">DOI: <a href=\"https:\/\/doi.org\/10.33731\/42025.346584\">https:\/\/doi.org\/10.33731\/42025.346584<\/a> <\/p>\n\n\n\n<p class=\"has-small-font-size\">Submitted&nbsp; &nbsp;&nbsp; 2025-07-29<br>Accepted &nbsp;&nbsp; &nbsp; 2025-10-02<br>Published &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2025-12-15<\/p>\n\n\n\n<div style=\"height:8px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img decoding=\"async\" src=\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\" alt=\"\" class=\"wp-image-6960\" style=\"width:131px;height:auto\"\/><\/figure>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n\n\n\n<div style=\"height:26px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p class=\"has-small-font-size\"><\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:66.66%\">\n<p class=\"has-medium-font-size\"><strong>New inventive step requirements to pharmaceutical inventions in Ukraine: will it help to protect a balance between public and private interests?<\/strong><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Oksana Kashyntseva<\/strong><br>Ph.D. (Law), Associate Professor,<br>Leading Researcher at the Department of Research on Intellectual Property Rights and Human Rights in the Healthcare Sector at the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine<br>Ukraine<br><a href=\"https:\/\/orcid.org\/0000-0002-2598-5614\">https:\/\/orcid.org\/0000-0002-2598-5614<\/a> <\/p>\n\n\n\n<p><strong>Sergiy Kondratyuk<\/strong><br>Ph.D. (Law), Acting Senior Scientific Researcher at the Department of Research on Intellectual Property Rights and Human Rights in the Healthcare Sector at the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine<br>Ukraine<br><a href=\"https:\/\/orcid.org\/0009-0006-3950-8217\">https:\/\/orcid.org\/0009-0006-3950-8217 <\/a><\/p>\n\n\n\n<p><\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>Abstract<br><\/strong>New edition of Rules for drafting, submitting, and examining an application for an invention and an application for a utility model adopted in Ukraine has the potential to limit evergreening for pharmaceutical inventions. The article analyzes the content of new anti-evergreening provisions for polymorphs, stereoisomers, and prodrugs introduced by the Rules, comparing them with international recommendations, European Patent Office and other jurisdictions\u2019 approaches. While this development may be perceived as positive, language on \u2018new technical property\u2019 may serve as a backdoor for patenting low-quality inventions.<\/p>\n\n\n\n<p><strong>Keywords: <\/strong>evergreening patents, TRIPS flexibilities, medicines, access in Ukraine<\/p>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><strong>References<\/strong><\/p>\n\n\n\n<p>\u041f\u0440\u043e \u0437\u0430\u0442\u0432\u0435\u0440\u0434\u0436\u0435\u043d\u043d\u044f \u041f\u0440\u0430\u0432\u0438\u043b \u0441\u043a\u043b\u0430\u0434\u0430\u043d\u043d\u044f, \u043f\u043e\u0434\u0430\u043d\u043d\u044f \u0442\u0430 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0438\u0437\u0438 \u0437\u0430\u044f\u0432\u043a\u0438 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u0456\u0434 \u0456 \u0437\u0430\u044f\u0432\u043a\u0438 \u043d\u0430 \u043a\u043e\u0440\u0438\u0441\u043d\u0443 \u043c\u043e\u0434\u0435\u043b\u044c: \u041d\u0430\u043a\u0430\u0437 \u041c\u0456\u043d\u0456\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u0430 \u0415\u043a\u043e\u043d\u043e\u043c\u0456\u043a\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 09.09.2024&nbsp;\u0440. \u2116 23301.<br><a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/z1411-24\/print\">https:\/\/zakon.rada.gov.ua\/laws\/show\/z1411-24\/print<\/a><\/p>\n\n\n\n<p>Correa C. Guidelines for the Examination of Patent Applications relating to Pharmaceuticals: Examining Pharmaceutical Patents From a Public Health Perspective. United Nations Development Programme. 2016. 48 p.<br><a href=\"https:\/\/www.undp.org\/sites\/g\/files\/zskgke326\/files\/publications\/UNDP_patents_final_web_3.pdf\">https:\/\/www.undp.org\/sites\/g\/files\/zskgke326\/files\/publications\/UNDP_patents_final_web_3.pdf<\/a><\/p>\n\n\n\n<p>\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. \u2116 3687-XII.<br><a href=\"https:\/\/zakon.rada.gov.ua\/laws\/show\/3687-12#Text\">https:\/\/zakon.rada.gov.ua\/laws\/show\/3687-12#Text<\/a><\/p>\n\n\n\n<p>India: Patent Act<em>, <\/em>1970.<br><a href=\"https:\/\/ipindia.gov.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf\">https:\/\/ipindia.gov.in\/writereaddata\/Portal\/IPOAct\/1_31_1_patent-act-1970-11march2015.pdf<\/a><\/p>\n\n\n\n<p>\u041f\u0435\u0442\u0440\u0435\u043d\u043a\u043e \u0421. \u0410., \u0416\u0438\u0445\u0430\u0440\u0454\u0432 \u041e. \u0421., \u0422\u0440\u043e\u0444\u0438\u043c\u0435\u043d\u043a\u043e \u041c. \u041c. \u0414\u043e\u0441\u043b\u0456\u0434\u0436\u0435\u043d\u043d\u044f \u0432\u0456\u0447\u043d\u043e\u0437\u0435\u043b\u0435\u043d\u0438\u0445 \u043f\u0430\u0442\u0435\u043d\u0442\u0456\u0432 \u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0456. \u041d\u0414\u0406 \u0406\u0412 \u041d\u0410\u041f\u0440\u041d \u0423\u043a\u0440\u0430\u0457\u043d\u0438, \u0411\u041e \u00ab100% \u0416\u0438\u0442\u0442\u044f\u00bb. \u041a\u0438\u0457\u0432, 2020. 56 \u0441.<br><a href=\"https:\/\/network.org.ua\/wp-content\/uploads\/2020\/12\/report_web_19.06-1fin.pdf\">https:\/\/network.org.ua\/wp-content\/uploads\/2020\/12\/report_web_19.06-1fin.pdf<\/a><\/p>\n\n\n\n<p>\u041c\u0435\u0442\u043e\u0434\u0438\u0447\u043d\u0456 \u0440\u0435\u043a\u043e\u043c\u0435\u043d\u0434\u0430\u0446\u0456\u0457 \u0437 \u043e\u043a\u0440\u0435\u043c\u0438\u0445 \u043f\u0438\u0442\u0430\u043d\u044c \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0438\u0437\u0438 \u0437\u0430\u044f\u0432\u043a\u0438 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u0456\u0434 (\u043a\u043e\u0440\u0438\u0441\u043d\u0443 \u043c\u043e\u0434\u0435\u043b\u044c): \u043d\u0430\u043a\u0430\u0437 \u0414\u0435\u0440\u0436\u0430\u0432\u043d\u043e\u0433\u043e \u043f\u0456\u0434\u043f\u0440\u0438\u0454\u043c\u0441\u0442\u0432\u0430 \u00ab\u0423\u043a\u0440\u0430\u0457\u043d\u0441\u044c\u043a\u0438\u0439 \u0456\u043d\u0441\u0442\u0438\u0442\u0443\u0442 \u043f\u0440\u043e\u043c\u0438\u0441\u043b\u043e\u0432\u043e\u0457 \u0432\u043b\u0430\u0441\u043d\u043e\u0441\u0442\u0456\u00bb \u0432\u0456\u0434 07 \u043a\u0432\u0456\u0442\u043d\u044f 2014 \u0440. \u2116 91.<br><a href=\"https:\/\/ukrpatent.org\/i_upload\/file\/metod-rekom-vynakhid-2017.pdf\">https:\/\/ukrpatent.org\/i_upload\/file\/metod-rekom-vynakhid-2017.pdf<\/a><\/p>\n\n\n\n<p>\u0420\u0456\u0448\u0435\u043d\u043d\u044f \u0410\u043f\u0435\u043b\u044f\u0446\u0456\u0439\u043d\u043e\u0457 \u043f\u0430\u043b\u0430\u0442\u0438 \u041c\u0456\u043d\u0456\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u0430 \u0435\u043a\u043e\u043d\u043e\u043c\u0456\u0447\u043d\u043e\u0433\u043e \u0440\u043e\u0437\u0432\u0438\u0442\u043a\u0443 \u0456 \u0442\u043e\u0440\u0433\u0456\u0432\u043b\u0456 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 16.02. 2018 \u0440. \u0449\u043e\u0434\u043e \u0437\u0430\u043f\u0435\u0440\u0435\u0447\u0435\u043d\u043d\u044f \u0413\u0410\u0419\u041b\u0406\u0414 \u0424\u0410\u0420\u041c\u0410\u0421\u0421\u0415\u0422 \u0415\u041b\u0415\u041b\u0421\u0406 \u043f\u0440\u043e\u0442\u0438 \u0440\u0456\u0448\u0435\u043d\u043d\u044f \u041c\u0456\u043d\u0456\u0441\u0442\u0435\u0440\u0441\u0442\u0432\u0430 \u0435\u043a\u043e\u043d\u043e\u043c\u0456\u0447\u043d\u043e\u0433\u043e \u0440\u043e\u0437\u0432\u0438\u0442\u043a\u0443 \u0456 \u0442\u043e\u0440\u0433\u0456\u0432\u043b\u0456 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 29.06.2017 \u043f\u0440\u043e \u0432\u0456\u0434\u043c\u043e\u0432\u0443 \u0443 \u0432\u0438\u0434\u0430\u0447\u0456 \u043f\u0430\u0442\u0435\u043d\u0442\u0443 \u043d\u0430 \u0432\u0438\u043d\u0430\u0445\u0456\u0434 \u00ab\u041d\u0443\u043a\u043b\u0435\u043e\u0437\u0438\u0434\u0444\u043e\u0441\u0444\u043e\u0440\u0430\u043c\u0456\u0434\u0430\u0442\u0438\u00bb \u0437\u0430 \u0437\u0430\u044f\u0432\u043a\u043e\u044e \u2116 \u0430 2012 12444.<br><a href=\"https:\/\/ukrpatent.org\/atachs\/nukleozid-im-res-2018.pdf\">https:\/\/ukrpatent.org\/atachs\/nukleozid-im-res-2018.pdf<\/a><\/p>\n\n\n\n<p>Ku S. Salt and Polymorph Selection Strategy Based on the Biopharmaceutical Classification System for Early Pharmaceutical Development. American Pharmaceutical Review. 2010. \u2116 1.<br><a href=\"https:\/\/www.americanpharmaceuticalreview.com\/Featured-Articles\/117500-Salt-and-Polymorph-Selection-Strategy-Based-on-the-Biopharmaceutical-Classification-System-for-Early-Pharmaceutical-Development\/\">https:\/\/www.americanpharmaceuticalreview.com\/Featured-Articles\/117500-Salt-and-Polymorph-Selection-Strategy-Based-on-the-Biopharmaceutical-Classification-System-for-Early-Pharmaceutical-Development\/<\/a><\/p>\n\n\n\n<p>Correa C. Guidelines for the examination of pharmaceutical patents: developing a public health perspective. 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Fundamentals of Medicinal Chemistry. Wiley, 2003. 304 \u0440.<\/p>\n\n\n\n<p>Sampat B., Shadlen K. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). DrugPatentWatch. 2018.<br><a href=\"https:\/\/doi.org\/10.1371\/journal.pone.0194714\">https:\/\/doi.org\/10.1371\/journal.pone.0194714<\/a><\/p>\n\n\n\n<p>Asuri N. Proper Interpretation of Section 3(d) of the Indian Patent Act Could Save Incremental Innovations of Existing Pharmaceutical Substances. IPWatchdog. 2019.<br><a href=\"https:\/\/ipwatchdog.com\/2019\/06\/22\/proper-interpretation-section-3d-indian-patent-act-save-incremental-innovations-existing-pharmaceutical-substances\/id=110581\/\">https:\/\/ipwatchdog.com\/2019\/06\/22\/proper-interpretation-section-3d-indian-patent-act-save-incremental-innovations-existing-pharmaceutical-substances\/id=110581\/<\/a><\/p>\n\n\n\n<p>Minderop R., Burrichter A., Kirchhofer N. Prodrugs and metabolites \u2013 in the twilight zone of patentability? IP and the Life Sciences Industries. 2013. P. 9-12.<br><a href=\"https:\/\/www.cohausz-florack.de\/fileadmin\/Artikel\/prodrugs_and_metabolites_in_the_twilight_zone_of_patentability_02.pdf\">https:\/\/www.cohausz-florack.de\/fileadmin\/Artikel\/prodrugs_and_metabolites_in_the_twilight_zone_of_patentability_02.pdf<\/a><\/p>\n\n\n\n<p>Boreski, D.; Schmid, V.F.; Bosquesi, P.L.; dos Santos, J.L.; Scarim, C.B.; Reshetnikov, V.; Chin, C.M. Current Trends in Clinical Trials of Prodrugs.&nbsp;Pharmaceuticals.&nbsp;2025.&nbsp;Vol. 18. \u0420. 210.<br><a href=\"https:\/\/doi.org\/10.3390\/ph18020210\">https:\/\/doi.org\/10.3390\/ph18020210<\/a><\/p>\n\n\n\n<p>Zawilska JB, Wojcieszak J, Olejniczak AB. Prodrugs: a challenge for the drug development. Pharmacological Reports. 2013. Vol. 65(1). P. 1-14.<br><a href=\"https:\/\/doi.org\/10.1016\/s1734-1140(13)70959-9\">https:\/\/doi.org\/10.1016\/s1734-1140(13)70959-9<\/a><\/p>\n\n\n\n<p>Stereochemical Issues in Chiral Drug Development Therapeutic Products Programme Guidance for Industry, Health Canada, May 1, 2000, 9 p.<br><a href=\"https:\/\/www.hc-sc.gc.ca\/dhp-mps\/alt_formats\/hpfb-dgpsa\/pdf\/prodpharma\/stereo-eng.pdf\">https:\/\/www.hc-sc.gc.ca\/dhp-mps\/alt_formats\/hpfb-dgpsa\/pdf\/prodpharma\/stereo-eng.pdf<\/a><\/p>\n\n\n\n<p>Domeij B. Pharmaceutical Patents in Europe (Stockholm Studies in Law). Leiden; Boston: Brill Nijhoff. 2000. 350 p.<br><a href=\"https:\/\/doi.org\/10.1163\/9789004481473\">https:\/\/doi.org\/10.1163\/9789004481473<\/a><\/p>\n\n\n\n<p>Wermuth C.G. The Practice of Medicinal Chemistry, Second Edition, Elsevier 2003, 768 p.<\/p>\n\n\n\n<p>Grubb P. Patents for chemicals, pharmaceuticals and biotechnology. Fundamentals of global law, practice and strategy. Clarendon Press. Oxford. 1999. 448 p.<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Theory and practice of intellectual property\u2116 4 \/ 2025 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/42025.346584 Submitted&nbsp; &nbsp;&nbsp; 2025-07-29Accepted &nbsp;&nbsp; &nbsp; 2025-10-02Published &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;2025-12-15 New inventive step requirements to pharmaceutical inventions in Ukraine: will it help to protect a balance between public and private interests? Oksana KashyntsevaPh.D. (Law), Associate Professor,Leading Researcher at the Department of Research [&hellip;]<\/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-7538","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/7538","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=7538"}],"version-history":[{"count":14,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/7538\/revisions"}],"predecessor-version":[{"id":8180,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/7538\/revisions\/8180"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=7538"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}