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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
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| 篇名： | 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 |
| TITLE： | Data analysis of class 1 patent declaration in generic drugs and its implications for generic drug development |
| 摘要： | 目的 为进一步完善药品专利链接制度，优化中国上市药品专利信息登记平台管理以及为仿制药企进行仿制研发、生产、上市提供指引。方法登录并检索国家药品监督管理局、中国上市药品专利信息登记平台、国家知识产权局等网站，以中国药品专利声明制度等法律政策信息、中国药品专利1类声明登记数据为检索内容，对以上数据进行整体挖掘，对1类声明中数量综合排名靠前的品种进行剖析，并结合我国的医药市场实践，对完善我国仿制药的1类声明制度提出建议。结果与结论化学仿制药1类声明占到总数的99%以上，1类声明件数排名前5的品种包括他达拉非片、玻璃酸钠滴眼液等。从整体与个例分析结果得出：我国应完善药品专利链接制度，通过建立知情权救济机制和建立依职权审查机制，完善中国上市药品专利信息登记平台功能，通过加强仿制药企在批准等待期的数据跟踪以及增设仿制药品种筛选功能，从而为仿制药企适时筛选仿制药品种提供参考。 |
| 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. |
| 期刊： | 2024年第35卷第09期 |
| 作者： | 汪宇；顾东蕾 |
| AUTHORS： | WANG Yu，GU Donglei |
| 关键字： | 仿制药；1类声明；药品专利连接制度 |
| KEYWORDS： | generic drug； class 1 drug patent declaration； drug patent linking system |
| 阅读数： | 13 次 |
| 本月下载数： | 0 次 |
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