Stanford Law School, Stanford, California.
Arizona State University Consortium for Science Policy and Outcomes, Washington, DC.
JAMA Health Forum. 2024 Nov 1;5(11):e243775. doi: 10.1001/jamahealthforum.2024.3775.
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.
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.
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.
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.
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.
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.
2023 年 12 月，拜登-哈里斯政府发布了一项拟议框架，根据《贝赫-多尔法案》（Bayh-Dole Act），对纳税人资助的药物专利行使政府强制许可权（实际上是为仿制药制造商授予这些专利的强制许可），这重新引发了关于强制许可权是否可以通过仿制药竞争降低成本或损害制药创新的问题。
确定使用强制许可权消除仿制药竞争专利障碍的可行性。
设计、设置和参与者：本横断面研究检查了来自多个来源的政府资助信息，这些信息涉及 1985 年至 2023 年《食品和药物管理局（FDA）橙皮书》中列出的专利。数据分析于 2024 年 8 月完成。
具有橙皮书专利的新药申请（NDA），包括（1）1985 年至 2022 年批准的所有新分子实体（NME）；（2）1985 年至 2023 年期间具有橙皮书专利的所有 NDA；和（3）最近（2023 年 10 月）橙皮书版中列出的未过期专利的 NDA。
主要结果是根据联邦资金确定的不同数据源确定的，药物是否具有任何或所有受《贝赫-多尔法案》管辖的公共部门专利。《贝赫-多尔法案》不允许对联邦政府内部研究产生的公共部门专利进行强制许可，因此将这些专利单独识别。
在 1985 年至 2022 年期间批准的 883 种新分子实体中，有 68 种（8%）具有《贝赫-多尔法案》专利，但仅有 18 种（2%）仅具有《贝赫-多尔法案》专利。在 1985 年至 2023 年期间列出专利的 2832 种药物中，有 142 种（5%）具有《贝赫-多尔法案》专利，但仅有 38 种（1%）仅具有《贝赫-多尔法案》专利。在 2023 年 10 月列入橙皮书的 1213 种药物专利中，有 41 种（3%）具有《贝赫-多尔法案》专利，但仅有 14 种（1%）仅具有《贝赫-多尔法案》专利。
这项横断面研究发现，尽管《贝赫-多尔法案》的强制许可权可以为少数药物消除仿制药进入的专利障碍，但它们的总体效果将是有限的。
