![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2023\/03\/018-cover-734x1024.jpg\")
<\/figure>\n\n\n\nTheory and practice of intellectual property
\u2116 3 \/ 2023<\/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 (English)<\/a><\/div>\n<\/div>\n\n\n\nDOI: https:\/\/doi.org\/10.33731\/32023.282331<\/a><\/p>\n\n\n\n Submitted 2023-04-18 <\/p>\n\n\n\n <\/p>\n<\/div>\n\n\n\n Abuse of patentability criteria when patenting inventionsrelated to medicines<\/strong><\/p>\n\n\n\n Sergiy Kondratyuk<\/strong> <\/p>\n\n\n\n Abstract Keywords: <\/strong>evergreening, secondary patents, TRIPS flexibilities, patentability criteria, medicines, pharmaceuticals<\/p>\n\n\n\n References<\/strong><\/p>\n\n\n\n Report of the United Nations Secretary-General\u2019s High Level Panel on Access to Medicines: Promoting Innovation and Access to Health Technologies, 2016, 70. \u041a\u043e\u043b\u0435\u043a\u0442\u0438\u0432\u043d\u0438\u0439 \u043b\u0438\u0441\u0442 \u043f\u0430\u0446\u0456\u0454\u043d\u0442\u0456\u0432 \u0437 \u043c\u0443\u043a\u043e\u0432\u0456\u0441\u0446\u0438\u0434\u043e\u0437\u043e\u043c \u0442\u0430 \u043f\u0430\u0446\u0456\u0454\u043d\u0442\u0441\u044c\u043a\u0438\u0445 \u043e\u0440\u0433\u0430\u043d\u0456\u0437\u0430\u0446\u0456\u0439 \u0434\u043e \u041c\u041e\u0417 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 6 \u043b\u044e\u0442\u043e\u0433\u043e 2023 \u0449\u043e\u0434\u043e \u00ab\u0414\u043e\u0441\u0442\u0443\u043f\u0443 \u0434\u043e \u043b\u0456\u043a\u0456\u0432 \u0432\u0456\u0434 \u043c\u0443\u043a\u043e\u0432\u0456\u0441\u0446\u0438\u0434\u043e\u0437\u0443 \u0422\u0440\u0438\u043a\u0430\u0444\u0442\u0430\/\u041a\u0430\u0444\u0442\u0440\u0456\u043e (\u0442\u0430 \u0456\u043d\u0448\u0438\u0445 \u043f\u0440\u0435\u043f\u0430\u0440\u0430\u0442\u0456\u0432 \u043a\u043e\u043c\u043f\u0430\u043d\u0456\u0457 Vertex) \u0434\u043b\u044f \u043f\u0430\u0446\u0456\u0454\u043d\u0442\u0456\u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0438\u00bb.<\/p>\n\n\n\n \u041b\u0438\u0441\u0442 \u041c\u041e\u0417 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 25-04\/KO-1267\/\/2586-\u0437\u0432 \u0432\u0456\u0434 16 \u0431\u0435\u0440\u0435\u0437\u043d\u044f 2023.<\/p>\n\n\n\n \u041b\u0456\u043d\u043f\u0430\u0440\u0437\u0430 \u0442\u0430\u0431\u043b\u0435\u0442\u043a\u0438, \u0432\/\u043f\u043b\u0456\u0432. \u041e\u0431\u043e\u043b. \u041f\u043e 150 \u043c\u0433 \u211656 (8\u04457): \u0446\u0456\u043d\u0430 \u0443 \u041a\u0438\u0454\u0432\u0456, Tabletki.ua (\u043f\u043e\u0440\u0442\u0430\u043b \u0444\u0430\u0440\u043c\u0430\u0446\u0435\u0432\u0442\u0438\u0447\u043d\u043e\u0457 \u043f\u0440\u043e\u0434\u0443\u043a\u0446\u0456\u0457). Olaparib Dosage. Drugs.com, last updated 8 December 2022. Olaparib Brancanat tablets 100mg and 150mg, IndiaMART marketplace. Correa C., Hilty R. Access to Medicines and Vaccines: Implementing Flexibilities Under Intellectual Property Law. Springer Cham, 2022. 373 p. UNDP, Good practice guide: Improving Access to Treatment by Utilizing Public Health Flexibilities in the WTO TRIPS Agreement, December 2010, 84. \u041a\u0430\u0448\u0438\u043d\u0446\u0435\u0432\u0430 \u041e. \u042e. \u0414\u043e\u0441\u0432\u0456\u0434 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0437 \u0456\u043c\u043f\u043b\u0435\u043c\u0435\u043d\u0442\u0430\u0446\u0456\u0457 \u0433\u043d\u0443\u0447\u043a\u0438\u0445 \u043f\u043e\u043b\u043e\u0436\u0435\u043d\u044c \u0423\u0433\u043e\u0434\u0438 \u0422\u0420\u0406\u041f\u0421 \u0443 \u0434\u0432\u043e\u0445 \u043a\u043e\u043d\u0442\u0435\u043a\u0441\u0442\u0430\u0445: \u0454\u0432\u0440\u043e\u0456\u043d\u0442\u0435\u0433\u0440\u0430\u0446\u0456\u0457 \u0442\u0430 \u043f\u0430\u043d\u0434\u0435\u043c\u0456\u0457. \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. 2021. \u2116 5. \u041f\u043e\u043d\u043e\u043c\u0430\u0440\u044c\u043e\u0432\u0430 \u041e. \u041f\u0440\u0438\u043c\u0443\u0441\u043e\u0432\u0430, \u0432\u0456\u0434\u043a\u0440\u0438\u0442\u0430 \u0442\u0430 \u0434\u043e\u0431\u0440\u043e\u0432\u0456\u043b\u044c\u043d\u0430 \u043b\u0456\u0446\u0435\u043d\u0437\u0456\u0457 \u043d\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438: \u0434\u0435\u044f\u043a\u0456 \u0430\u0441\u043f\u0435\u043a\u0442\u0438 \u043f\u0440\u0430\u0432\u043e\u0437\u0430\u0441\u0442\u043e\u0441\u0443\u0432\u0430\u043d\u043d\u044f. \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. 2019. \u2116 3. \u0416\u0438\u0445\u0430\u0440\u0435\u0432 \u041e. \u041e\u0441\u043e\u0431\u043b\u0438\u0432\u043e\u0441\u0442\u0456 \u043f\u0440\u043e\u0432\u0435\u0434\u0435\u043d\u043d\u044f \u0435\u043a\u0441\u043f\u0435\u0440\u0442\u0438\u0437\u0438 \u043f\u0430\u0442\u0435\u043d\u0442\u0456\u0432 \u043d\u0430 \u043b\u0456\u043a\u0430\u0440\u0441\u044c\u043a\u0456 \u0437\u0430\u0441\u043e\u0431\u0438, \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. 2022. \u2116 6. Gurgula O. The ‘obvious to try’ method of addressing strategic patenting: How developing countries can utilize patent law to facilitate access to medicines. Policy Brief, South Centre, 2019. South Centre, Correa C., February 2016, Implementing Pro-Competitive Criteria for the Examination of Pharmaceutical Patents, 44. UNDP, Correa \u0421. Guidelines for the Examination of Patent Applications relating that Pharmaceuticals: Examining Pharmaceutical Patents From a Public Health Perspective , New York 2016, 48. Kapczynski A, Park C, Sampat B (2012) Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of \u201cSecondary\u201d Pharmaceutical Patents. PLoS ONE 7(12): e49470. EC Competition DG, 2009, Pharmaceutical Sector Inquiry: Final Report, 533. Tahir Amin and Aaron S. Kesselheim, Secondary Patenting of Branded Pharmaceuticals: A Case Study of How Patents on Two HIV Drugs Could Be Extended for Decades, Health Affairs, 31, no. 10 (2012), 9. Chaves, Viera et al., 2018, Medicines under Exclusivity Situation Funded by the Ministry of Health: Analysis of the Patent Situation and Public Procurement, Rio de Janeiro, Fiocruz\/ENSP, 200. AbbVie Inc. v Amgen Inc. Complaint in the US District Court DE, 4 August, 2016, 49. Phebe Hong, Stopping the Pharmaceutical \u00abProduct Hop\u00bb, Bill of Health, the blog of the Petrie-Flom Center at Harvard Law School, 11 October 2019. Evergreening patents may make drugs too costly for patients in Thailand (Generics and Biosimilars Initiative, 2013). Association Agreement between the European Union and its Member States, of the one part, and Ukraine, of the other part, 27 June 2014. Petrenko S., Zhykharev O., Trofymentko M., Evegreening patents in Ukraine: Report, 2020, 100% Life, 60. Christopher M. Holman, Timo Minssen, and Eric M. Solovy. Patentability Standards for Follow-On Pharmaceutical Innovation. Biotechnology Law Report.Jun 2018.131-161. Melissa J Barber , Dzintars Gotham , Giten Khwairakpam , and Andrew Hill . 9\/2020. ” Price of a hepatitis C cure: Cost of production and current prices for direct-acting antivirals in 50 countries .” Journal of Virus Eradication, 6, 3. Publisher’s Version. MedsPal: the Medicines Patents and Licenses Database, Medicines Patent Pool. Patent on Hep C drug rejected in Ukraine: Price of sofosbuvir will significantly reduce, 14 March 2018, Make Medicines Affordable Campaign website, ITPC Global. Argentine Joint Resolution 118\/2012, 546\/2012 and 107\/2012 (Ministry of Industry, Ministry of Health and National Industrial Property Institute), Adoption of Guidelines for the Examination of Patent Applications of Chemical and Pharmaceutical Inventions, 2012, 8. German Velasquez, Research Paper, SC 2015, Guidelines on patentability and access to medicines, 44. Vieira, Di Giano, 2018, Taking on the challenge of implementing public health safeguards on the ground, in Routledge Handbook on the Politics of Global Health. Park, Chan. 2010. \u201cChapter 2A: Implementation of India’s Patent Law: A Review of Patents Granted by the Indian Patent Office.\u201d In Five Years into the Product Patent Regime: India’s Response, by Sudip Chaudhuri, Chan Park, and KM Gopakumar. United Nations Development Programme. Ali, Feroz, Sudarsan Rajagopal, Venkata S. Raman, and Roshan John. 2018. \u00abPharmaceutical Patent Grants in India: How Our Safeguards against Evergreening Have Failed, and Why the System Must Be Reformed\u00bb. Breakthrough success as reformed patent law enters into force in Ukraine, 21 August 2020. \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u00ab\u041f\u0440\u043e \u0432\u043d\u0435\u0441\u0435\u043d\u043d\u044f \u0437\u043c\u0456\u043d \u0434\u043e \u0434\u0435\u044f\u043a\u0438\u0445 \u0437\u0430\u043a\u043e\u043d\u043e\u0434\u0430\u0432\u0447\u0438\u0445 \u0430\u043a\u0442\u0456\u0432 \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0449\u043e\u0434\u043e \u0440\u0435\u0444\u043e\u0440\u043c\u0438 \u043f\u0430\u0442\u0435\u043d\u0442\u043d\u043e\u0433\u043e \u0437\u0430\u043a\u043e\u043d\u043e\u0434\u0430\u0432\u0441\u0442\u0432\u0430 \u0432\u0456\u0434 21 \u043b\u0438\u043f\u043d\u044f 2020 \u2116 816-IX. \u041f\u0440\u043e \u0437\u0430\u0445\u0438\u0441\u0442 \u0456\u043d\u0442\u0435\u0440\u0435\u0441\u0456\u0432 \u043e\u0441\u0456\u0431 \u0443 \u0441\u0444\u0435\u0440\u0456 \u0456\u043d\u0442\u0435\u043b\u0435\u043a\u0442\u0443\u0430\u043b\u044c\u043d\u043e\u0457 \u0432\u043b\u0430\u0441\u043d\u043e\u0441\u0442\u0456 \u043f\u0456\u0434 \u0447\u0430\u0441 \u0434\u0456\u0457 \u0432\u043e\u0454\u043d\u043d\u043e\u0433\u043e \u0441\u0442\u0430\u043d\u0443, \u0432\u0432\u0435\u0434\u0435\u043d\u043e\u0433\u043e \u0443 \u0437\u0432\u2019\u044f\u0437\u043a\u0443 \u0456\u0437 \u0437\u0431\u0440\u043e\u0439\u043d\u043e\u044e \u0430\u0433\u0440\u0435\u0441\u0456\u0454\u044e \u0420\u043e\u0441\u0456\u0439\u0441\u044c\u043a\u043e\u0457 \u0424\u0435\u0434\u0435\u0440\u0430\u0446\u0456\u0457 \u043f\u0440\u043e\u0442\u0438 \u0423\u043a\u0440\u0430\u0457\u043d\u0438: \u0417\u0430\u043a\u043e\u043d \u0423\u043a\u0440\u0430\u0457\u043d\u0438 \u0432\u0456\u0434 1 \u043a\u0432\u0456\u0442\u043d\u044f 2023 \u21162174-IX. Theory and practice of intellectual property\u2116 3 \/ 2023 ISSN (Print) 2308-0361ISSN (Online) 2519-2744 DOI: https:\/\/doi.org\/10.33731\/32023.282331 Submitted 2023-04-18Accepted 2023-05-17Published 2023-06-19 Abuse of patentability criteria when patenting inventionsrelated to medicines Sergiy KondratyukPhD student at the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of UkraineUkrainehttps:\/\/orcid.org\/0009-0006-3950-8217 AbstractIt is well known […]<\/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-8668","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8668","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=8668"}],"version-history":[{"count":3,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8668\/revisions"}],"predecessor-version":[{"id":8671,"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/pages\/8668\/revisions\/8671"}],"wp:attachment":[{"href":"https:\/\/inprojournal.org\/en\/wp-json\/wp\/v2\/media?parent=8668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
Accepted 2023-05-17
Published 2023-06-19<\/p>\n\n\n\n![\"\"](\"https:\/\/inprojournal.org\/wp-content\/uploads\/2025\/11\/CC-2.png\")
<\/figure>\n\n\n\n
PhD student at the Intellectual Property Scientific Research Institute of the National Academy of Legal Sciences of Ukraine
Ukraine
https:\/\/orcid.org\/0009-0006-3950-8217<\/a><\/p>\n\n\n\n
<\/strong>It is well known that intellectual property monopolies for medicines reduce physical and economic availability. The main purpose of the study is to conduct a brief review of foreign scholarly views on evergreening patenting practice in the field of pharmaceuticals, to demonstrate the implications of such abusive practice, and to exemplify good practices used in several countries to address the problem. Evergreening practice poses a serious challenge for the healthcare system of Ukraine, but there are promising examples in several countries (e.g., Argentina, Brazil, India) of limiting evergreening.<\/p>\n\n\n\n
http:\/\/www.unsgaccessmeds.org\/final-report<\/a><\/p>\n\n\n\n
https:\/\/tabletki.ua\/uk\/%D0%9B%D0%B8%D0%BD%D0%BF%D0%B0%D1%80%D0%B7%D0%B0\/39753\/pharmacy\/kiev\/<\/a><\/p>\n\n\n\n
https:\/\/www.drugs.com\/dosage\/olaparib.html#Usual_Adult_Dose_for_Prostate_Cancer<\/a><\/p>\n\n\n\n
https:\/\/www.indiamart.com\/proddetail\/olaparib-bracanat-tablets-2850369330191.html<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.1007\/978-3-030-83114-1<\/a><\/p>\n\n\n\n
https:\/\/www.undp.org\/sites\/g\/files\/zskgke326\/files\/publications\/Good%20Practice%20Guide-Improving%20access%20to%20treatment%20by%20utilizing%20public%20health%20flexibilities%20in%20the%20WTO%20TRIPS%20agreement.pdf<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.33731\/52021.244533<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.33731\/32019.173811<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.33731\/62022.274630<\/a><\/p>\n\n\n\n
https:\/\/www.southcentre.int\/wp-content\/uploads\/2019\/04\/PB59_The-obvious-to-try-method-of-addressing-strategic-patenting_EN.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.southcentre.int\/wp-content\/uploads\/2016\/02\/RP64_Examination-of-pharma-patents_EN.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.undp.org\/publications\/guidelines-examination-patent-applications-relating-pharmaceuticals<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.1371\/journal.pone.0049470<\/a><\/p>\n\n\n\n
https:\/\/ec.europa.eu\/competition\/sectors\/pharmaceuticals\/inquiry\/staff_working_paper_part1.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.healthaffairs.org\/doi\/10.1377\/hlthaff.2012.0107<\/a><\/p>\n\n\n\n
https:\/\/accessibsa.org\/media\/2020\/11\/Medicines-under-Exclusivity-Situation-funded-by-the-Ministry-of-Health.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.bigmoleculewatch.com\/wp-content\/uploads\/sites\/2\/2016\/08\/ded-1-99-cv-de431-1.pdf<\/a><\/p>\n\n\n\n
https:\/\/blog.petrieflom.law.harvard.edu\/2019\/10\/11\/stopping-the-pharmaceutical-product-hop\/<\/a><\/p>\n\n\n\n
https:\/\/www.gabionline.net\/policies-legislation\/Evergreening-patents-may-make-drugs-too-costly-for-patients-in-Thailand<\/a><\/p>\n\n\n\n
https:\/\/www.kmu.gov.ua\/storage\/app\/sites\/1\/uploaded-files\/TITLE%20IV.pdf<\/a><\/p>\n\n\n\n
https:\/\/network.org.ua\/wp-content\/uploads\/2020\/12\/Report-eng-curves-1-1.pdf<\/a><\/p>\n\n\n\n
http:\/\/doi.org\/10.1089\/blr.2018.29073.cmh<\/a><\/p>\n\n\n\n
https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2055664020300017<\/a><\/p>\n\n\n\n
https:\/\/www.medspal.org\/?page=1<\/a><\/p>\n\n\n\n
https:\/\/makemedicinesaffordable.org\/patent-on-hep-c-drug-rejected-in-ukraine-price-of-sofosbuvir-will-significantly-reduce\/<\/a><\/p>\n\n\n\n
https:\/\/www.wipo.int\/edocs\/lexdocs\/laws\/es\/ar\/ar109es.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.southcentre.int\/wp-content\/uploads\/2015\/03\/RP61_Guidelines-on-Patentability-and-A2M_rev2_EN.pdf<\/a><\/p>\n\n\n\n
https:\/\/www.taylorfrancis.com\/chapters\/edit\/10.4324\/9781315297255-32\/taking-challenge-implementing-public-health-safeguards-ground-marcela-foga%C3%A7a-vieira-lorena-di-giano<\/a><\/p>\n\n\n\n
https:\/\/doi.org\/10.13140\/RG.2.1.4584.0088<\/a><\/p>\n\n\n\n
https:\/\/www.accessibsa.org\/media\/2018\/04\/Pharmaceutical-Patent-Grants-in-India.pdf<\/a><\/p>\n\n\n\n
https:\/\/makemedicinesaffordable.org\/breakthrough-success-as-reformed-patent-law-enters-into-force-in-ukraine\/ <\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/816-20#n96<\/a><\/p>\n\n\n\n
https:\/\/zakon.rada.gov.ua\/laws\/show\/2174-20#Text<\/a>
<\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"