摘要
《与贸易有关的知识产权协定》规定了药品试验数据规制的基本制度,此基础上我国采取商业秘密规制模式保护药品试验数据。但是,商业秘密规制模式一方面存在保护力度不足等问题,另一方面存在药品试验数据无法进入“公域”的问题。《全面与进步跨太平洋伙伴关系协定》(The Comprehensive and Progressive Agreement for Trans-Pacific Partnership,CPTPP)构建了更高标准的药品试验数据规制制度,具体包括采取数据专有权、保护生物制剂试验数据等。为对接CPTPP,我国应重构药品试验数据规制制度,具体包括确立数据专有权模式并明确保护期限,此外构建药品试验数据公开制度和规制后续排他权的制度。
The Agreement on Trade-Related Aspects of Intellectual Property Rights(TRIPS)stipulates the basic system for regulating pharmaceutical test data.Based on this,China adopts the trade secret model to protect pharmaceutical test data.However,the trade secret regulation model has problems such as insufficient protection on one hand,and on the other hand,there is the issue of pharmaceutical test data not being able to enter the"public domain".The Comprehensive and Progressive Agreement for Trans-Pacific Partnership(CPTPP)has established a higher-standard system for regulating pharmaceutical test data,which specifically includes the adoption of data exclusivity and the protection of biologic test data.To align with the CPTPP,China should reconstruct its system for regulating pharmaceutical test data.This specifically includes establishing a data exclusivity model and clarifying the protection period,as well as building a system for disclosing pharmaceutical test data and a system for regulating follow-on exclusivity.
作者
潘坤
PAN Kun(School of Intellectual Property,Nanjing University of Science and Technology,Nanjing 210094,China;School of Law,Peking University,Beijing 100871,China)
出处
《医学与哲学》
北大核心
2025年第21期67-71,80,共6页
Medicine and Philosophy
基金
2025年中国法学会部级课题[CLS(2025)D59]
2025年江苏省高校哲学社会科学一般项目(2025SJYB0032)。
关键词
《全面与进步跨太平洋伙伴关系协定》
药品试验数据
数据专有权
后续排他权
The Comprehensive and Progressive Agreement for Trans-Pacific Partnership
pharmaceutical test data
data exclusivity
follow-on exclusivity
作者简介
潘坤(1992-),男,博士,讲师,研究方向:知识产权法。E-mail:1010197359@qq.com。
