Center for Integration of Science and Industry, Bentley University, Waltham, Massachusetts, United States of America.
Department of Natural & Applied Sciences, Bentley University, Waltham, Massachusetts, United States of America.
PLoS One. 2023 Jul 26;18(7):e0288447. doi: 10.1371/journal.pone.0288447. eCollection 2023.
Previous studies have shown that National Institutes of Health (NIH) funding contributed >$187 billion for basic or applied research related to the 356 drugs approved 2010-2019. This analysis asks how much of this funding led to patents cited as providing market exclusivity, patents that would be subject to the provisions of the Bayh-Dole Act that promote and protect the public interest. The method involves identifying published research in PubMed related to the approved drugs (applied research) or their targets (basic research). NIH-funded projects (grants) funding these publications and patents arising from these projects were both identified in RePORT. Patents cited as providing market exclusivity were identified in DrugPatentWatch (which incorporates FDA Orange Book). NIH funded basic or applied research related to all 313 FDA-approved drugs 2010-2019 with at least one patent in DrugPatentWatch. This research comprised 350 thousand publications (9% applied research; 91% basic research) supported by 341 thousand fiscal years (project years) of NIH funding and $164 billion in NIH project year costs (17% applied research; 83% basic research). These NIH projects also produced 22,360 patents, 119 of which were cited in DrugPatentWatch as protecting 34/313 drugs. These patents were associated with 769 project years of NIH funding (0.23% total) and project year costs of $0.95 billion (0.59% total). Overall, only 1.5% of total NIH funding for applied research and 0.38% of total NIH funding for basic research was associated with patents in DrugPatentWatch. This analysis shows that very little of the NIH funding for research that contributes to new drug approvals leads to patents that provide market exclusivity and are subject to the provisions of the Bayh-Dole Act that promote the public interest in practical applications of the research, reasonable use and pricing, and a return on this public sector investment. This suggests that the Bayh-Dole Act is limited in its ability to protect the public interest in the pharmaceutical innovations driven by NIH-funded research.
先前的研究表明，美国国立卫生研究院（NIH）的资金为 2010 年至 2019 年期间批准的 356 种药物的基础或应用研究提供了超过 1870 亿美元的资金。本分析旨在探讨这些资金中有多少用于支持专利申请，以获得市场独占权，这些专利将受到促进和保护公众利益的《拜杜法案》规定的约束。该方法涉及在 PubMed 中确定与已批准药物（应用研究）或其靶点（基础研究）相关的已发表研究。NIH 在 RePORT 中识别了资助这些出版物和项目专利的 NIH 资助项目（赠款）。在 DrugPatentWatch 中确定了被引用为提供市场独占权的专利（该数据库纳入了 FDA 橙皮书）。NIH 为 2010 年至 2019 年期间获得 FDA 批准的所有 313 种药物中的 313 种提供了 NIH 资助的基础或应用研究，这些药物都至少有一种专利被收录在 DrugPatentWatch 中。这项研究由 35 万篇出版物（9%的应用研究；91%的基础研究）组成，这些出版物得到了 34.1 万个财政年度（项目年度）的 NIH 资助，NIH 项目年度支出为 1640 亿美元（17%的应用研究；83%的基础研究）。这些 NIH 项目还产生了 22360 项专利，其中 119 项在 DrugPatentWatch 中被引用为保护 34/313 种药物。这些专利与 NIH 资助的 769 个项目年度（占总数的 0.23%）和 9.5 亿美元的项目年度支出（占总数的 0.59%）有关。总体而言，只有应用研究总 NIH 资助的 1.5%和基础研究总 NIH 资助的 0.38%与 DrugPatentWatch 中的专利有关。这项分析表明， NIH 资助的新药批准相关研究中，只有很少一部分导致了提供市场独占权的专利，而这些专利受《拜杜法案》的规定约束，这些规定旨在促进公众对研究的实际应用、合理使用和定价产生兴趣，并对公共部门的投资产生回报。这表明《拜杜法案》在保护公众对 NIH 资助的研究驱动的药物创新的利益方面能力有限。
