摘要
中国已初步构建生物制品专利纠纷早期解决机制(early resolution mechanism of patent disputes,ERMPD),但是制度尚不完整。该文在厘清生物制品ERMPD的内涵、意义、模式类型和典型国家机制内容的基础上,探讨模式选择因素,从而为中国未来健全生物制品ERMPD提供参考。当前,完整的生物制品ERMPD可分为“软链接模式”和“硬链接模式”两种。模式选择受模式效应、产业发展、专利保护特点、国际贸易战略等因素影响。建议中国未来在健全生物制品ERMPD时,结合上述因素,选择更适合本国国情的制度模式。
China has initially established early resolution mechanism of patent disputes(ERMPD) for biologics, but it is not yet complete. On the basis of clarifying the definition, function, type of the mechanism and content of typical national mechanism, this paper discusses the infuencing factors of mode selection, so as to provide references for China to improve the ERMPD for biologics in the future. The present complete ERMPD for biologics can be divided into “soft linkage mode” and “hard linkage mode”. The model selection affected by factors such as mode function, industrial development,patent protection features, and international trade strategy. It is suggested that when improving the ERMPD for biologics in the future, China should combine the above factors and choose an institutional model that is more suitable for its national conditions.
作者
王秀
姚雪芳
丁锦希
WANG Xiu;YAO Xuefang;DING Jinxi(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,Jiangsu Province,China;School of Health Economics and Management,Jiangsu Nanjing University of Chinese Medicine,Nanjing 210023,Jiangsu Province,China;Pharmaceutical Market Access Policy Research Center,China Pharmaceutical University,Nanjing 211198,Jiangsu Province,China)
出处
《世界临床药物》
CAS
2022年第11期1387-1392,共6页
World Clinical Drug
关键词
生物制品
专利纠纷
早期解决机制
模式选择
软链接
硬链接
biologic product
patent dispute
mechanism for early resolution
model selection
hard linkage
soft linkage
