利用《贝-多尔法案》的进军权降低美国药品价格。

IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES JAMA Health Forum Pub Date : 2024-11-01 DOI:10.1001/jamahealthforum.2024.3775
Lisa Larrimore Ouellette, Bhaven N Sampat
{"title":"利用《贝-多尔法案》的进军权降低美国药品价格。","authors":"Lisa Larrimore Ouellette, Bhaven N Sampat","doi":"10.1001/jamahealthforum.2024.3775","DOIUrl":null,"url":null,"abstract":"<p><strong>Importance: </strong>In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.</p><p><strong>Objectives: </strong>To determine the feasibility of using march-in rights to remove patent barriers to generic competition.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023. Data analysis was completed in August 2024.</p><p><strong>Exposures: </strong>New drug applications (NDAs) with Orange Book-listed patents, including (1) all new molecular entities (NMEs) approved from 1985 to 2022; (2) all NDAs with an Orange Book patent listed between 1985 and 2023; and (3) NDAs with unexpired patents listed in a recent (October 2023) edition of the Orange Book.</p><p><strong>Main outcomes and measures: </strong>The main outcome was whether the drugs had any or all patents that were public-sector patents subject to the Bayh-Dole Act, based on combining different data sources for identifying patents that resulted from federal funding. Public-sector patents resulting from intramural research, which are not subject to march-in rights under the Bayh-Dole Act, were identified separately.</p><p><strong>Results: </strong>Of 883 new molecular entities approved from 1985 to 2022, 68 (8%) had a Bayh-Dole patent, but only 18 (2%) had solely Bayh-Dole patents. Of 2832 drugs with patents listed for 1985 to 2023, 142 (5%) had a Bayh-Dole patent, but only 38 (1%) had solely Bayh-Dole patents. Of 1213 drugs with Orange Book patents listed in October 2023, 41 (3%) had a Bayh-Dole patent, but only 14 (1%) had solely Bayh-Dole patents.</p><p><strong>Conclusion and relevance: </strong>This cross-sectional study found that, although Bayh-Dole march-in rights could remove patent barriers to generic entry for a few drugs, their overall effect would be limited.</p>","PeriodicalId":53180,"journal":{"name":"JAMA Health Forum","volume":"5 11","pages":"e243775"},"PeriodicalIF":9.5000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530938/pdf/","citationCount":"0","resultStr":"{\"title\":\"Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.\",\"authors\":\"Lisa Larrimore Ouellette, Bhaven N Sampat\",\"doi\":\"10.1001/jamahealthforum.2024.3775\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Importance: </strong>In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.</p><p><strong>Objectives: </strong>To determine the feasibility of using march-in rights to remove patent barriers to generic competition.</p><p><strong>Design, setting, and participants: </strong>This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023. Data analysis was completed in August 2024.</p><p><strong>Exposures: </strong>New drug applications (NDAs) with Orange Book-listed patents, including (1) all new molecular entities (NMEs) approved from 1985 to 2022; (2) all NDAs with an Orange Book patent listed between 1985 and 2023; and (3) NDAs with unexpired patents listed in a recent (October 2023) edition of the Orange Book.</p><p><strong>Main outcomes and measures: </strong>The main outcome was whether the drugs had any or all patents that were public-sector patents subject to the Bayh-Dole Act, based on combining different data sources for identifying patents that resulted from federal funding. Public-sector patents resulting from intramural research, which are not subject to march-in rights under the Bayh-Dole Act, were identified separately.</p><p><strong>Results: </strong>Of 883 new molecular entities approved from 1985 to 2022, 68 (8%) had a Bayh-Dole patent, but only 18 (2%) had solely Bayh-Dole patents. Of 2832 drugs with patents listed for 1985 to 2023, 142 (5%) had a Bayh-Dole patent, but only 38 (1%) had solely Bayh-Dole patents. Of 1213 drugs with Orange Book patents listed in October 2023, 41 (3%) had a Bayh-Dole patent, but only 14 (1%) had solely Bayh-Dole patents.</p><p><strong>Conclusion and relevance: </strong>This cross-sectional study found that, although Bayh-Dole march-in rights could remove patent barriers to generic entry for a few drugs, their overall effect would be limited.</p>\",\"PeriodicalId\":53180,\"journal\":{\"name\":\"JAMA Health Forum\",\"volume\":\"5 11\",\"pages\":\"e243775\"},\"PeriodicalIF\":9.5000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11530938/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA Health Forum\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1001/jamahealthforum.2024.3775\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA Health Forum","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1001/jamahealthforum.2024.3775","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
引用次数: 0

摘要

重要性:2023 年 12 月,拜登-哈里斯政府(Biden-Harris Administration)根据《贝-多尔法案》(Bayh-Dole Act)就纳税人资助药品的专利权发布了一项行使政府进军权(实际上是向仿制药制造商授予这些专利的强制许可)的拟议框架,这再次引发了关于进军权是否能通过仿制药竞争促进成本节约或损害制药创新的问题:目的:确定使用 "进入权 "消除专利对仿制药竞争的障碍的可行性:这项横断面研究从多个来源考察了1985年至2023年食品药品管理局(FDA)桔皮书中所列专利的政府资助信息。数据分析于 2024 年 8 月完成:具有桔皮书所列专利的新药申请(NDA),包括(1)1985年至2022年期间批准的所有新分子实体(NME);(2)1985年至2023年期间具有桔皮书所列专利的所有NDA;以及(3)具有最近(2023年10月)版桔皮书所列未到期专利的NDA:主要结果是药物是否拥有任何或所有受 Bayh-Dole 法案约束的公共部门专利,其依据是综合不同的数据来源,以确定由联邦资助产生的专利。由校内研究产生的公共部门专利不受《贝-多尔法》规定的 "进军权 "的限制,这些专利将被单独识别:在 1985 年至 2022 年期间批准的 883 个新分子实体中,有 68 个(8%)拥有 Bayh-Dole 专利,但只有 18 个(2%)仅拥有 Bayh-Dole 专利。在 1985 年至 2023 年期间获得专利的 2832 种药物中,142 种(5%)拥有 Bayh-Dole 专利,但只有 38 种(1%)仅拥有 Bayh-Dole 专利。在 2023 年 10 月拥有桔皮书专利的 1213 种药物中,41 种(3%)拥有 Bayh-Dole 专利,但只有 14 种(1%)仅拥有 Bayh-Dole 专利:这项横向研究发现,尽管 Bayh-Dole 进军权可以消除少数药品进入仿制药市场的专利障碍,但其总体效果有限。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
Using Bayh-Dole Act March-In Rights to Lower US Drug Prices.

Importance: In December 2023, the Biden-Harris Administration released a proposed framework for exercising government march-in rights (effectively granting compulsory licenses for those patents to generic drug makers) under the Bayh-Dole Act on patents on taxpayer-funded drugs, which has renewed questions about whether march-in rights could promote cost savings through generic competition or harm pharmaceutical innovation.

Objectives: To determine the feasibility of using march-in rights to remove patent barriers to generic competition.

Design, setting, and participants: This cross-sectional study examined government funding information from multiple sources for patents listed in the Food and Drug Administration (FDA) Orange Book from 1985 to 2023. Data analysis was completed in August 2024.

Exposures: New drug applications (NDAs) with Orange Book-listed patents, including (1) all new molecular entities (NMEs) approved from 1985 to 2022; (2) all NDAs with an Orange Book patent listed between 1985 and 2023; and (3) NDAs with unexpired patents listed in a recent (October 2023) edition of the Orange Book.

Main outcomes and measures: The main outcome was whether the drugs had any or all patents that were public-sector patents subject to the Bayh-Dole Act, based on combining different data sources for identifying patents that resulted from federal funding. Public-sector patents resulting from intramural research, which are not subject to march-in rights under the Bayh-Dole Act, were identified separately.

Results: Of 883 new molecular entities approved from 1985 to 2022, 68 (8%) had a Bayh-Dole patent, but only 18 (2%) had solely Bayh-Dole patents. Of 2832 drugs with patents listed for 1985 to 2023, 142 (5%) had a Bayh-Dole patent, but only 38 (1%) had solely Bayh-Dole patents. Of 1213 drugs with Orange Book patents listed in October 2023, 41 (3%) had a Bayh-Dole patent, but only 14 (1%) had solely Bayh-Dole patents.

Conclusion and relevance: This cross-sectional study found that, although Bayh-Dole march-in rights could remove patent barriers to generic entry for a few drugs, their overall effect would be limited.

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
CiteScore
4.00
自引率
7.80%
发文量
0
期刊介绍: JAMA Health Forum is an international, peer-reviewed, online, open access journal that addresses health policy and strategies affecting medicine, health, and health care. The journal publishes original research, evidence-based reports, and opinion about national and global health policy. It covers innovative approaches to health care delivery and health care economics, access, quality, safety, equity, and reform. In addition to publishing articles, JAMA Health Forum also features commentary from health policy leaders on the JAMA Forum. It covers news briefs on major reports released by government agencies, foundations, health policy think tanks, and other policy-focused organizations. JAMA Health Forum is a member of the JAMA Network, which is a consortium of peer-reviewed, general medical and specialty publications. The journal presents curated health policy content from across the JAMA Network, including journals such as JAMA and JAMA Internal Medicine.
期刊最新文献
Cannabis Use During Early Pregnancy Following Recreational Cannabis Legalization. Change of Ownership and Quality of Home Health Agency Care. Errors in Conflict of Interest Disclosures. JAMA Health Forum. Surgeon Workforce in Underserved Communities.
×
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
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 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 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1