引入延长药品专利期限的有效期限制(上限)法规

Chihyun Kwon
{"title":"引入延长药品专利期限的有效期限制(上限)法规","authors":"Chihyun Kwon","doi":"10.38133/cnulawreview.2023.43.3.117","DOIUrl":null,"url":null,"abstract":"The current patent law stipulates that the period required to obtain a drug product license under the Pharmaceutical Affairs Act is regarded as a period in which a drug patent holder could not carry out a drug patent invention for a business and the duration can be extended up to a maximum of five years. However, there is no regulation on the validity limit (cap) of the duration for the combined period the extended duration and the residual duration. \nAs a result, regardless of the date on which the drug is licensed, the drug patent holder receives an extension of the duration of up to five years and controls the drug market with an exclusive status. Meanwhile, generic pharmaceutical companies do not have a cap on the validity of the extended duration, so entry into the market of generic (or biosimilar) drugs may be restricted for a long time. There is a problem that the market supply of cheap generic drugs is delayed, which rather hinders the promotion of national health. \nUnder the current regulation that the duration can be extended for up to five years as a way to solve these problems, like the United States, the EU, and China, it is necessary to introduce a maximum valid limit (cap) regulation in the Patent Act that the combined period of “extended duration” and “residual duration” cannot exceed a certain period (e.g., 14 years).","PeriodicalId":288398,"journal":{"name":"Institute for Legal Studies Chonnam National University","volume":"15 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Introduction of the validity limit (cap) regulation for the duration of the extended pharmaceutical patent\",\"authors\":\"Chihyun Kwon\",\"doi\":\"10.38133/cnulawreview.2023.43.3.117\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The current patent law stipulates that the period required to obtain a drug product license under the Pharmaceutical Affairs Act is regarded as a period in which a drug patent holder could not carry out a drug patent invention for a business and the duration can be extended up to a maximum of five years. However, there is no regulation on the validity limit (cap) of the duration for the combined period the extended duration and the residual duration. \\nAs a result, regardless of the date on which the drug is licensed, the drug patent holder receives an extension of the duration of up to five years and controls the drug market with an exclusive status. Meanwhile, generic pharmaceutical companies do not have a cap on the validity of the extended duration, so entry into the market of generic (or biosimilar) drugs may be restricted for a long time. There is a problem that the market supply of cheap generic drugs is delayed, which rather hinders the promotion of national health. \\nUnder the current regulation that the duration can be extended for up to five years as a way to solve these problems, like the United States, the EU, and China, it is necessary to introduce a maximum valid limit (cap) regulation in the Patent Act that the combined period of “extended duration” and “residual duration” cannot exceed a certain period (e.g., 14 years).\",\"PeriodicalId\":288398,\"journal\":{\"name\":\"Institute for Legal Studies Chonnam National University\",\"volume\":\"15 1\",\"pages\":\"0\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-08-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Institute for Legal Studies Chonnam National University\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.38133/cnulawreview.2023.43.3.117\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Institute for Legal Studies Chonnam National University","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.38133/cnulawreview.2023.43.3.117","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

现行专利法规定,根据《药事法》获得药品许可的期限,视为药品专利权人不能开展药品专利发明活动的期限,最长可延长5年。但是,对合并期限、延长期限和剩余期限的有效期限(上限)没有规定。因此,无论药物获得许可的日期如何,药物专利持有人都可以获得长达五年的延长期限,并以排他性地位控制药物市场。同时,仿制药公司对延长期限的有效期没有上限,因此仿制药(或生物仿制药)进入市场可能会长期受到限制。有一个问题是,廉价仿制药的市场供应被推迟,这相当妨碍了促进国民健康。为了解决这些问题,像美国、欧盟和中国一样,在现行规定最长可以延长5年的情况下,有必要在《专利法》中引入“延长期限”和“剩余期限”之和不能超过一定期限(如14年)的最大有效限制(cap)规定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Introduction of the validity limit (cap) regulation for the duration of the extended pharmaceutical patent
The current patent law stipulates that the period required to obtain a drug product license under the Pharmaceutical Affairs Act is regarded as a period in which a drug patent holder could not carry out a drug patent invention for a business and the duration can be extended up to a maximum of five years. However, there is no regulation on the validity limit (cap) of the duration for the combined period the extended duration and the residual duration. As a result, regardless of the date on which the drug is licensed, the drug patent holder receives an extension of the duration of up to five years and controls the drug market with an exclusive status. Meanwhile, generic pharmaceutical companies do not have a cap on the validity of the extended duration, so entry into the market of generic (or biosimilar) drugs may be restricted for a long time. There is a problem that the market supply of cheap generic drugs is delayed, which rather hinders the promotion of national health. Under the current regulation that the duration can be extended for up to five years as a way to solve these problems, like the United States, the EU, and China, it is necessary to introduce a maximum valid limit (cap) regulation in the Patent Act that the combined period of “extended duration” and “residual duration” cannot exceed a certain period (e.g., 14 years).
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信