医药领域专利无效周期及成功率研究分析  

Research and analysis of the cycle and success rate of the invalidation of pharmaceutical patents

作　　者：明志会[1] 黄文杰 刘彩连[1] 檀爱民[1] 罗伟佳 任晋生[1] MING Zhi-hui;HUANG Wen-jie;LIU Cai-lian;TAN Ai-min;LUO Wei-jia;REN Jin-sheng(Jiangsu Simcere Pharmaceutical Co. , Ltd. , Nanjing 210042, China;Beijing Ourchem Intellectual Property Service Co. , Ltd. , Beijing 100192, China)

机构地区：[1]江苏先声药业有限公司,南京210042 [2]北京奥凯知识产权服务有限公司,北京100192

出　　处：《中国新药杂志》2018年第12期1334-1339,共6页Chinese Journal of New Drugs

基　　金：转化医学与创新药物国家重点实验室;江苏省企业知识产权战略推进计划重点项目(ZTZD1603)

摘　　要：研究了近10年医药领域中国专利无效宣告的概况。通过统计分析以恒瑞医药、正大天晴、中信国健为代表的中国医药企业的专利无效和无效后进入行政诉讼程序的案件情况,了解医药领域中国专利无效及从无效申请到行政诉讼最终判决的周期和成功率;另一方面,通过统计以梯瓦公司、山德士公司、麦兰公司、奥北泰克公司为代表的四家全球仿制药巨头在美国提起的IPR(双方复审)审查情况,分析了医药领域IPR程序的周期和成功率,有助于医药企业做好中国及美国专利无效的相关工作。This paper summarizes the invalidation of Chinese pharmaceutical patents in the last decade. By analyzing the invalidation cases and the following administrative litigations of pharmaceutical companies represented by Hengrui Medicine,Chiatai Tianqing Pharma,Sunshine Guojian Pharma,we are able to understand the cycle and success rate of the invalidation of Chinese pharmaceutical patents,and the period from the application date of patent invalidation to the date when the final judgment of the administrative litigation is made. This paper also summarizes the IPR cases of four global generics giants represented by Teva,Sandoz,Mylan,Apotex in order to understand the cycle and success rate of IPR program in pharmaceutical industry,which will help the pharmaceutical enterprises to prepare the patent invalid work in China and the USA.

关 键 词：医药领域 无效宣告 周期 成功率 IPR程序 

分 类 号：R95[医药卫生—药学]