中国药房2024，Vol.35Issue(9)：1034-1038,5.DOI:10.6039/j.issn.1001-0408.2024.09.02
仿制药专利声明中1类声明数据分析及对仿制药研发的启示
Data analysis of class 1 patent declaration in generic drugs and its implications for generic drug development
摘要
Abstract
OBJECTIVE To optimize the management of the China Listed Drug Patent Information Registration Platform as well as to provide guidelines and references for generic drug enterprises to carry out generic research,production and launch in order to further improve the drug patent linkage system.METHODS The used method is to log in and search the National Medical Products Administration(NMPA),China Listed Drug Patent Information Registration Platform,China National Intellectual Property Administration(CNIPA)and other websites.The search content included the Chinese drug patent declaration system and other legal or policy information,as well as registration data for class 1 drug patent declarations in China.The above data were mined as a whole together with analysis of the varieties with a high composite ranking in the quantity with class 1 declaration;the improvement measures for China's class 1 declaration system for generic drugs were put forward based on the practice of Chinese pharmaceutical market.RESULTS&CONCLUSIONS Class 1 drug patent declarations of chemical generic drugs accounted for over 99%of the total,and there were 5 varieties among the top 5 in the number of class 1 patent declarations(e.g.Tadalafil tablets,Sodium hyaluronate eye drops).Based on the analysis of the overall situation and individual cases,it is suggested that China should improve its drug patent linkage system;improve functions of China Listed Drug Patent Information Registration Platform by establishing relief mechanism of right-to-know and ex officio examination;help companies select generic drug varieties timely by strengthening data tracking of generic drug companies during the pending approval period and adding a generic drug variety screening function.关键词
仿制药/1类声明/药品专利连接制度Key words
generic drug/class 1 drug patent declaration/drug patent linking system分类
医药卫生引用本文复制引用
汪宇,顾东蕾..仿制药专利声明中1类声明数据分析及对仿制药研发的启示[J].中国药房,2024,35(9):1034-1038,5.基金项目
2023年江苏省知识产权战略推进计划项目(No.KY20230047_02) （No.KY20230047_02）
