药品集中采购中专利侵权争议解决路径研究——以企业药品违背“三类声明”承诺情形为例  

Research on the Resolution Path of Patent Infringement Disputes in Centralized Pharmaceutical Procurement——A Case Study of enterprise drugs violating the“three categories statement”

作　　者：孙阳 宗欣 Sun Yang;Zong Xin(Beijing Medical Centralized Purchasing Service Center,Beijing 100161,China;School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China)

机构地区：[1]北京市医药集中采购服务中心,北京100161 [2]首都医科大学药学院,北京100069

出　　处：《卫生法学》2024年第6期98-102,126,共6页Health Law

摘　　要：随着国家药品审评审批改革不断深化,企业仿制尚在专利保护期的原研药并获得药品注册证书成为可能,这对促进仿制药行业发展、提高药物可及性等方面发挥了重要作用。然而实践中,如仿制药企业违背向中国上市药品专利信息登记平台提交的,在被仿原研药专利期届满前暂不上市的“三类声明”,在药品集中采购平台进行挂网,有涉许诺销售专利侵权之嫌。尝试对药品挂网行为许诺销售专利侵权性质认定进行讨论,对药品集中采购部门处理该类争议的应有原则以及如何完善争议解决机制提出政策建议。With the continuous deepening of the reform of national drug review and approval system,it is possible for enterprises to copy the original drugs under patent protection and obtain drug registration certificates,which has played an important role in promoting the development of the generic drug industry and improving drug accessibility.However,in practice,some enterprises violated the“three categories of statements”submitted to the Chinese patent information registration platform for listed drugs at the beginning of listing that generic drugs would not be listed until the expiration of the generic patent period,and went online on the drug centralized procurement platform,which is suspected of infringement of the promised sales patent.This paper attempts to discuss the infringement of offering for Sale,refine the principles that should be followed by drug centralized procurement departments,and put forward policy suggestions on how to improve such dispute resolution mechanisms.

关 键 词：药品集中采购 药品挂网 许诺销售 专利侵权 争议解决 

分 类 号：D902[政治法律—法学理论]