使用 Bayh-Dole Act 游行权来降低美国药物价格
Lisa Larrimore Ouellette1, Bhaven N Sampat2
1Stanford Law School, Stanford, California.
JAMA health forum
|November 1, 2024
概括
根据"贝伊-多尔法案" (Bayh-Dole Act) 的政府征集权,可以为有限数量的纳税人资助的药物提供仿制药的竞争. 然而,它们对增加通用药物获取的整体影响预计将是最小的.
科学领域:
- 卫生政策 卫生政策
- 知识产权法 知识产权法 知识产权法
- 制药经济学 制药经济学
背景情况:
- 贝伊-多尔法案允许政府在联邦资助发明的专利上获得专利许可的"进军权".
- 最近的提案建议将这些权利用于纳税人资助的药物,以促进仿制药竞争并降低成本.
- 人们担心这种方法对制药创新的潜在影响以及这种方法的可行性.
研究的目的:
- 评估政府游行权的潜力,以克服仿制药进入的专利障碍.
- 在FDA色书中列出的药物中,量化符合征集权的专利的普遍性.
主要方法:
- 一项横截面研究分析了FDA色书 (1985-2023) 中的专利政府资助数据.
- 数据来源被结合起来,以识别来自联邦资助的专利,将其与室内研究专利区分开来.
- 包括新的分子实体 (NME),所有持有色书专利的NDA,以及持有未过期专利的NDA.
主要成果:
- 只有很小一部分药物拥有专利,这些专利完全来自联邦资金,受"贝伊-多尔法案"的约束.
- 对于NME (1985-2022年),只有2%的人拥有贝伊-多尔专利.
- 在所有拥有专利的药物 (1985-2023年) 中,只有1%的药物仅拥有贝伊-多尔专利.
结论:
- 虽然Bayh-Dole的征集权理论上可以解决一些药物的专利障碍,但它们对仿制药竞争的实际影响是有限的.
- 专门由联邦政府资助的专利的低普及率表明,在促进通用药物的获取方面,游行权的范围受到限制.
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