在行政专利挑战后,生物药物收入的变化
Adam J N Raymakers1, Victor L Van de Wiele2, Aaron S Kesselheim3
1Adam J. N. Raymakers, Harvard University and Brigham and Women's Hospital, Boston, Massachusetts.
Health affairs (Project Hope)
|March 3, 2025
概括
美国发明法案.
科学领域:
- 药品制造业 药品制造业 药品制造业 药品制造业
- 知识产权法 知识产权法 知识产权法
- 卫生经济学 卫生经济学
背景情况:
- 品牌药物制造商,特别是生物制剂制造商,获得了众多的专利.
- 这些专利可能会阻碍低成本生物类似替代品进入市场.
- 美国发明法为专利挑战引入了当事人间审查 (IPR).
研究的目的:
- 分析各方审查对生物药物专利的利用和影响.
- 评估知识产权在促进生物相似药物竞争方面的有效性.
- 评估专利无效对原始药物收入的经济后果.
主要方法:
- 对2012-2021年生物药物的行政专利挑战 (当事方审查) 的分析.
- 根据用户 (生物类似药与生物制造商) 和专利类型对挑战的分类.
- 检查专利无效后原始产品的收入变化.
主要成果:
- 在涉及生物药物的知识产权文件中作了43项最终书面决定 (2012-2021年).
- 生物类似公司无效了14项专利 (在20个挑战中),主要是治疗方法专利.
- 生物公司无效 17 项专利 (在 23 项诉讼中),主要是活性成分专利.
- 生物仿制药公司的专利无效与原始产品收入的下降有关.
结论:
- 双方审查是对生物药物专利提出挑战的重要途径.
- 生物类似制造商有效地使用知识产权来克服专利障碍.
- 生物仿制药成功申请专利,提高了市场竞争,潜在地降低了患者和支付人的药物成本.
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