{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T16:10:57Z","timestamp":1786983057789,"version":"build-2736575974"},"reference-count":24,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T00:00:00Z","timestamp":1765411200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T00:00:00Z","timestamp":1765411200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"General Project of Philosophy and Social Science Research in Colleges and Universities of Jiangsu Province","award":["2024SJYB0240"],"award-info":[{"award-number":["2024SJYB0240"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Ther Innov Regul Sci"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In January 2024, China officially implemented the patent term extension (PTE) system, that is, began to implement PTE for innovative drugs approved after June 1, 2021. This study analyzed the PTE system\u2019s outcomes in China and its potential impact on drug accessibility.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a simulation analysis of the PTE duration and effective patent life after listing (EPLL) of innovative drugs approved by Chinese regulatory authorities from June 2021 to December 2024, using data collected from public databases such as China\u2019s marketed drug patent registration platform.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 148 innovative drugs were included in the study. Among them, 61% were able to obtain PTE, with a median PTE duration of 5\u00a0years (IQR: 2.3\u20135). The median EPLL before adding PTE was 9\u00a0years (IQR: 6.1\u201311.7), and the median EPLL after adding PTE was 14\u00a0years (IQR: 11.1\u201314), an increase of 55.6%. Furthermore, the study reveals variations across drug types and therapeutic areas.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Compared to findings from prior studies on the U.S. and the European Union, the median PTE duration for innovative drugs in China is longer, while the median EPLL is only marginally extended. Both Chinese domestic stakeholders and foreign enterprises should evaluate the potential impact by considering both the incremental PTE periods and the overall EPLL levels.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s43441-025-00903-x","type":"journal-article","created":{"date-parts":[[2025,12,11]],"date-time":"2025-12-11T15:50:34Z","timestamp":1765468234000},"page":"544-550","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Patent Term Extension for Innovative Drugs in China: A Cohort Study from 2021 to 2024"],"prefix":"10.1007","volume":"60","author":[{"given":"Xuefang","family":"Yao","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jin","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,12,11]]},"reference":[{"issue":"06","key":"903_CR1","doi-asserted-by":"publisher","first-page":"177","DOI":"10.16390\/j.cnki.issn1672-0393.2019.06.015","volume":"36","author":"H He","year":"2019","unstructured":"He H. Construction of drug patent term restoration system in China \u2013 analysis of the implementation of \u2018Healthy China\u2019 strategy. Stud Law Bus. 2019;36(06):177. https:\/\/doi.org\/10.16390\/j.cnki.issn1672-0393.2019.06.015.","journal-title":"Stud Law Bus"},{"issue":"4","key":"903_CR2","doi-asserted-by":"publisher","first-page":"427","DOI":"10.4155\/ppa.12.47","volume":"1","author":"L Clark","year":"2012","unstructured":"Clark L, Beadle D. Patent term extensions: issues, challenges and implications for pharmaceuticals. Pharm Pat Anal. 2012;1(4):427\u201330. https:\/\/doi.org\/10.4155\/ppa.12.47.","journal-title":"Pharm Pat Anal"},{"issue":"07","key":"903_CR3","first-page":"12","volume":"17","author":"Y-K Liu","year":"2020","unstructured":"Liu Y-K. The dispute, selection and adjustment of China\u2019s establishment of the drug patent term extension system. 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Sci Technol Law. 2020;2020(04):11\u201321. https:\/\/doi.org\/10.19685\/j.cnki.cn11-2922\/n.2020.04.002.","journal-title":"Sci Technol Law"},{"issue":"1","key":"903_CR6","doi-asserted-by":"publisher","DOI":"10.1186\/s12992-022-00826-4","volume":"18","author":"B Tenni","year":"2022","unstructured":"Tenni B, Moir HVJ, Townsend B, et al. What is the impact of intellectual property rules on access to medicines? A systematic review. Glob Health. 2022;18(1):40. https:\/\/doi.org\/10.1186\/s12992-022-00826-4.","journal-title":"Glob Health"},{"issue":"4","key":"903_CR7","first-page":"443","volume":"28","author":"J Chen","year":"2017","unstructured":"Chen J, Shi L-W. Introduction and profound consideration on intellectual property rights protection standard terms related to drugs beyond the regulations of TRIPS. China Pharm. 2017;28(4):443\u20135.","journal-title":"China Pharm"},{"key":"903_CR8","first-page":"25","volume":"06","author":"W-Q Ye","year":"2021","unstructured":"Ye W-Q. 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