Data analysis of class 1 patent declaration in generic drugs and its implications for generic drug development
- VernacularTitle: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
- Author:
Yu WANG
1
;
Donglei GU
2
Author Information
1. Party Committee Office，China Pharmaceutical University，Nanjing 211198，China
2. Library and Information Center，China Pharmaceutical University，Nanjing 211198，China
- Publication Type:Journal Article
- Keywords:
generic drug;
class 1 drug patent declaration;
drug patent linking system
- From:
China Pharmacy
2024;35(9):1034-1038
- CountryChina
- Language:Chinese
-
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.
