摘要
[研究目的]我国药品专利链接制度整体沿用了美式制度,然而制度价值取向与我国药业实际有所出入。因此有必要对链接制度进行逻辑解构与比较解构,为我国实现链接制度本土化重构提供理论基础与经验借鉴。[研究方法]采取文献分析法、比较分析法和案例分析法对药品专利链接制度进行研究,一是分析链接制度的运行逻辑及利弊,环节包括专利登记、试验例外、简化审批、专利挑战、拟制侵权、暂停期和市场独占期等;二是分析链接制度的内化逻辑及优劣,形式包括被动嫁接型、坚决抵制型和理性内化型。[研究结论]以域外制度改良经验为借鉴、以我国药品产业实际为根本,我国应当加大专利登记审查力度、将专利挑战拟制为侵权、严格设置等待期启动条件、科学设计损害赔偿制度和严格审查反向支付协议,以链接制度创新推进药品技术创新,推动原研药和仿制药协同发展,最终实现我国从制药大国迈向制药强国。
[Research purpose]China's drug patent linkage system as a whole copied the American system,but the value orientation of the system is different from the reality of China's pharmaceutical industry.Therefore,it is necessary to carry out logical deconstruction and comparative deconstruction of linkage system to provide theoretical basis and experience for the localization and reconstruction of linkage system in China.[Research method]Literature analysis,comparative analysis and case analysis were used to study the drug patent linkage system.First,the operation logic and advantages and disadvantages of the system were analyzed,including patent registration,trial exception,simplified approval,patent challenge,proposed infringement,suspension period and market monopoly period.Second,the internalization logic and advantages and disadvantages of linkage system were analyzed,including passive grafting type,resolute resistance type and rational internalization type.[Research conclusion]China should take the experiences of the overseas systems to improve themselves seriously as valuable reference and at the same time taking into consideration the status quo of the medicine industry in China as the basis.China should strengthen patent registration review,define patent challenge as patent infringement,set strict waiting period start conditions,scientifically design compensation system and strictly review reverse payment agreement,in order to promote pharmaceutical technology innovation,coordinate development of the original drugs and generic drugs via linkage system innovation,thus to eventually promote China to develop into a pharmaceutical power.
作者
聂琳峰
刘少军
Nie Linfeng;Liu Shaojun(Civil,Commercial and Economic Law School,China University of Political Science and Law,Beijing 100088)
出处
《情报杂志》
CSSCI
北大核心
2022年第9期199-206,F0003,共9页
Journal of Intelligence
基金
江西省高校人文社会科学重点研究基地项目“药品价格垄断行为的法律规制研究”(编号:JD21053)的研究成果之一。
关键词
专利链接制度
药品专利
纠纷早期解决机制
原研药
仿制药
patent linkage system
drug patent
early dispute settlement mechanism
the original drugs
generic drug
