中国药品专利纠纷早期解决机制的建立与实践  

Establishment and Practice of Early Resolution Mechanism for Drug Patent Disputes in China

作　　者：余欢 蓝恭涛 杨云云 杨胜 YU Huan;LAN Gong-tao;YANG Yun-yun;YANG Sheng(Department of Drug Registration,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品注册管理司

出　　处：《中国食品药品监管》2023年第11期4-9,共6页China Food & Drug Administration Magazine

摘　　要：本文系统梳理了我国药品专利纠纷早期解决机制的建立与实践情况,并对产业界广泛关注的等待期、生物制品专利纠纷早期解决、市场独占期等有关工作考虑进行研究解读,体现了我国制度设计的特点及独有优势。知识产权保护是一个长期命题,贯穿药品生产、销售的全生命周期,药品专利纠纷早期解决机制仅是知识产权保护中的一个阶段,其健康有序运行,离不开企业的诚信参与,亦期待多部门协作,共同做好知识产权保护。This article systematically reviews the establishment and practice of early resolution mechanisms for pharmaceutical patent disputes in China.It delves into the industry's widely concerned aspects,including the waiting period,early resolution of biological product patent disputes,and market exclusivity period,showcasing the distinctive characteristics and advantages of China's institutional design.This reflects the characteristics and unique advantages of China's institutional design.Intellectual property protection is a long-term commitment that runs through the entire lifecycle of drug production and sales.The early resolution mechanism for drug patent disputes is just one stage of intellectual property protection.Its effective and orderly operation relies on the honest participation of enterprises,emphasizing the need for collaboration among multiple departments to jointly improve intellectual property protection.

关 键 词：药品专利纠纷早期解决机制 专利链接 知识产权保护 等待期 市场独占期 

分 类 号：R95[医药卫生—药学]