中国药品专利无效宣告案件实证研究

Empirical Research of Drug Patent Invalidity Declaratory Cases in China

关键词:  药品专利  无效宣告  创造性  许可引进  专利研发

Key words:  drug patent  invalidation  creativity  licensing-in  patent research and development

摘要:

目的 在对中国近年药品专利无效宣告相关案件检索分析的基础上，对中国制药企业运营及管理提出了相关建议。方法 统计了2005年1月1日—2022年12月31日国家知识产权局专利复审委员会受理的药品专利无效宣告请求案件共503件，分别从药品专利无效宣告案件数量、请求人、专利权人、法律依据和关联诉讼等维度进行分析。结果 药品无效宣告请求案件数量逐年快速上升；对无效宣告决定不服而进入行政诉讼的平均审结周期为31.1个月；从判决结果来看，药品专利无效的成功率>50%。结论 制药企业在药品研发、上市的全流程中需注意专利评估、分析与管理，提升自主研发能力与专利管理质量。

Abstract:

OBJECTIVE Based on the retrieval and analysis of cases related to the invalidation of drug patents in recent years in China, this paper puts forward relevant suggestions on the operation and management of pharmaceutical enterprises in China. METHODS According to analyzes a total of 503 invalidation request cases filed with the National Intellectual Property Administration from January 1, 2005 to July 12, 2020, analyzed them from the dimensions of the number of cases, involved parties, legal basis, related litigation, etc., which aimed to systematically and comprehensively understand the general situation of patent invalidation cases in the field of medicine in China. RESULTS The number of cases was increasing rapidly year by year, gradually forming a complete closed loop of patent challenges with litigation; the average closing period of administrative litigation after an invalidation case declared was 31.1 months. Judging from the judgment results, the success of patent invalidation rate over 50%. CONCLUSION Pharmaceutical enterprises should pay attention to patent evaluation, analysis and management in the whole process of drug R&D and marketing, improve their independent R&D capabilities and patent management quality.