{"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}
引用次数: 0
Abstract
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.
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.
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