覆盖的使用方法专利,以防止通用产品进入
Jin Park1, Aaron S Kesselheim2, S Sean Tu2,3
1https://ror.org/03vek6s52Harvard Medical School, Boston, MA.
概括
品牌制药公司使用"使用代码"来阻止仿制药的竞争,阻碍人们获得负担得起的药物. 重叠的代码阻碍了"薄标签"的途径,延迟了仿制药的进入,增加了医疗保健成本.
科学领域:
- 制药政策 制药政策
- 知识产权法 知识产权法
- 卫生经济学 卫生经济学
背景情况:
- 品牌制药公司利用使用方法专利和书使用代码来扩大市场排他性.
- "薄标签"途径允许仿制药省略专利说明,促进非专利用途进入市场.
- 重叠的使用代码,针对特定的患者子组或生物标志物值,对瘦身标签途径构成了新的挑战.
研究的目的:
- 分析重叠的使用代码如何阻碍薄标签路径.
- 检查这些做法对仿制药进入,成本和患者获取的影响.
- 建议对FDA和USPTO监督和法律标准进行改革.
主要方法:
- 分析最近关于使用方法专利和使用规范的诉讼.
- 关于icosapent ethyl (Vascepa) 和sacubitril-valsartan (Entresto) 的案例研究.
- 审查FDA和USPTO在使用代码分配方面的做法.
主要成果:
- 重叠的使用代码有效地阻碍了瘦身标签的途径,延迟了通用竞争.
- 涉及Vascepa和Entresto的诉讼证明了这些代码如何膨胀成本并限制患者获得负担得起的替代品.
- 目前的监管和法律标准不充分解决重叠代码的战略使用,以阻止通用入口.
结论:
- 改革是必要的,以加强FDA和USPTO对使用代码分配的监督.
- 澄清诱导侵权的法律标准至关重要.
- 为了保持创新激励和及时获得负担得起的药物之间的平衡,需要解决滥用使用代码的问题.
关键词:
食品和药物法律 食品和药物法律"色书"就是色的书.使用方法的使用方法.patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent patent瘦身的标签 瘦身的标签
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