制药行业专利无效宣告请求活动的总体特征分析
Analysis of the overall characteristics of patent invalidation request activities in the pharmaceutical industry
李艳 1朱雪忠2
作者信息
- 1. 南京理工大学知识产权学院,南京 210094;南京理工大学江苏国际知识产权学院,南京 210094
- 2. 同济大学上海国际知识产权学院,上海 200092
- 折叠
摘要
"健康中国战略"背景下,我国新出台的"药品专利链接制度"使专利无效宣告请求成为制药企业争取首仿权和市场独占期的重要工具.本文以国家知识产权局专利局复审和无效审理部公布的专利无效宣告请求审查决定为依据,采用统计分析路径,定量呈现制药行业不同药品类型专利无效宣告请求活动的发生频率、无效宣告请求审查结果、频繁被提无效宣告请求的专利权人及活跃度较高的无效请求人等总体关键特征.研究发现,我国市场上不同药品类型的专利权被提无效宣告请求的频率不同,审查结果亦不同;化学药发明专利被提无效宣告请求的频率最高,其次是中药和生物制品;化学药专利被宣告全部无效和部分无效的比例之和也最高,其次是生物制品和中药;化学药和生物制品被提无效宣告请求频率较高的专利权人主要是国外企业,而中药被提无效宣告请求频率较高的则是本土企业;化学药、生物制品和中药活跃度较高的无效宣告请求人都主要是本土药企.研究结论有利于制药企业深入了解行业竞争环境,提升对新制度和新环境的应对能力,推动我国制药产业的技术创新和转型升级.
Abstract
Under the background of"Healthy China Strategy",China's newly issued"Drug Patent Linkage System"has made patent invalidation request an important tool for the pharmaceutical companies to strive for the first imitation right and market exclusivity period.The statistical analysis path was used to quantitatively present the overall key features of patent invalidation requests activities for different-type drugs of pharmaceutical industry,such as the frequency,outcomes of patent invalidation requests,the patentees who are frequently requested for patent invalidation,and the petitioners for invalidation with high frequency,based on the data of drug patent invalidation decisions published by the Patent Reexamination and Invalidation Department of the Patent Office,China National Intellectual Property Administration(CNIPA).We found that the frequency and the examination outcome of patent invalidation requests of different-type drugs in the Chinese market are different.The frequency of invalidation requests for chemical drug invention patents is the highest,followed by traditional Chinese medicine and biological products.The proportion of patent rights invalidated in the examination outcome of chemical drug patents is also the highest,followed by biological products and traditional Chinese medicine.Patentees with higher frequency of invalidation requests for chemical drugs and biological products are mainly foreign pharmaceutical companies,while those with a higher frequency of invalidation requests for traditional Chinese medicine are mainly local pharmaceutical companies.The most active petitioners for invalidation are mainly domestic pharmaceutical companies.The highly active petitioners for invalidation for chemical drugs,biological products and traditional Chinese medicine are mainly local pharmaceutical companies.It is beneficial for pharmaceutical companies to have a deep understanding of the competitive environment in pharmaceutical industry,in order to enhance the ability to respond to new systems and environments,and to promote technological innovation,transformation,and upgrading of China's pharmaceutical industry.
关键词
药品专利链接制度/专利无效宣告请求/制药企业/竞争环境Key words
drug patent linkage system/patent invalidation requests/pharmaceutical companies/competitive environment引用本文复制引用
基金项目
中央高校基本科研业务费专项资金资助项目(30924011006)
国家社科基金重大项目(19ZDA102)
出版年
2024
NETL
NSTL
万方数据