我国药品专利期限补偿制度相关实务研究

Practical research on the compensation system for drug patent term in China

摘要

我国药品专利期限补偿制度已正式实施,但在实务中仍存在诸多热点问题亟待解决。本文结合具体案例,深入探讨部分关键问题,并对企业专利布局、期限补偿申请策略等方面提出思考与建议。首先介绍药品专利期限补偿制度的法律渊源,包括美国、日本、欧洲等国家/地区的制度情况。其次,阐述我国在该制度适用范围、补偿期限、计算方法及获得条件等方面的法律制度构建。重点分析我国实务操作中出现的问题,如“新药”定义、“一个药品”含义、权利要求是否涵盖新药技术方案以及保护范围限制等,并给出相应解决方案。最后,从法律意义角度为企业提出多项专利布局策略和调整新药申报策略等建议,以助力企业在药品专利期限补偿制度下更好地保护自身权益。

Abstract

China's drug patent term compensation system has officially been implemented, but numerous hot-button issues remain unresolved in practice. This paper delves into several key problems through specific case studies, offering reflections and recommendations on corporate patent strategy and term compensation application approaches. It begins by introducing the legal origins of the drug patent term compensation system, including practices in countries such as the United States, Japan, and Europe. Then, it elaborates on the legal framework of China's system regarding scope of application, compensation duration, calculation methods, and eligibility criteria. Subsequently, it focuses on analyzing practical operational challenges in China, such as the definition of “new drugs”, the meaning of “one drug”, whether claims encompass new drug technical solutions, and protection scope limitations, while proposing corresponding solutions. Finally, based on legal significance, it provides enterprises with multiple patent strategy recommendations and adjustments to new drug application strategies, aiming to help them better safeguard their rights under the drug patent term compensation system.

关键词

药品专利期限补偿 / 补偿权利保护范围 / 权利属性 / 专利布局 / 申请策略

Key words

patent term extension compensation for pharmaceuticals / scope of rights protection / nature of rights / patent landscaping / application strategies

[1] 国家知识产权局. 《专利审查指南》(2023)修改解读(二)[EB/OL].(2024-01-28).https://www.cnipa.gov.cn/art/2024/1/18/art_2199_189879.html.
[2] 高鹏. 美国药品专利期限延长法律制度研究[J]. 电子知识产权, 2024(2): 65-72.
[3] 马秋娟, 杨倩, 王璟, 等. 各国药品专利期限补偿制度的比较研究[J]. 中国新药杂志, 2018, 27(24): 2855-2860.
[4] 杨莉, 李野. 浅析药品专利期延长制度[J]. 中国新药杂志, 2007, 16(12): 905-908.
[5] 朱佳英, 王世超. 基于DRG支付体系的浙江省国家医保谈判药品落地政策研究与改进策略[J]. 中国现代应用药学, 2024, 41(21): 3037-3042.
[6] 陈浮, 吴红丽. 日本创新药品专利期限延长制度[J]. 中国科技信息, 2022(7): 13-14.
[7] 刘晴, 黄超峰. 浅谈欧洲药品专利期补偿制度的现状和发展趋势[J]. 中国新药杂志, 2021, 30(4): 295-299.
[8] 国家知识产权局. 专利审查指南(2023)[EB/OL].(2023-12-21).https://www.cnipa.gov.cn/art/2023/12/21/art_526_189193.html.
[9] 国家知识产权局. 中国专利审查信息查询系统[EB/OL].(2025-08-23).https://cpquery.cponline.cnipa.gov.cn/chinesepatent/index.
[10] 摩熵医药. 中药专利‘极限’延长5年！独家解析万亿市场的护城河博弈[EB/OL].(2025-02-10).https://mp.weixin.qq.com/s/Gnex_NgI_WMt9gLCORN_Iw.