医药领域专利无效周期及成功率研究分析
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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.
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.
引文
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[6]美国法典[S].第35卷.第314(a)节.
[7]林淘曦,余娜,黄璐.美国首仿药制度及专利挑战策略研究[J].中国新药杂志,2016,25(19):2168-2173.
[8]麦丽谊,陈昕,安金蒙,等.美国仿制药申请中应注意的问题及对我国的启示[J].今日药学,2017,27(10):675-682.
[9]纪媛媛,周东明.从知识产权角度浅析仿制药企业的发展之道[J].中国新药杂志,2016,25(11):1212-1215.
[2]知识产权出版社有限责任公司.中国知识产权大数据与智慧服务系统,DI Inspiro[EB/OL].[2017-11-15].http://www.zldsj.com/txn Decision List.do.
[3]国家知识产权专利复审委员会.查询中心-审查决定检索[EB/OL].[2017-03-28].http://app.sipo-reexam.gov.cn/reexam_out1110/search Index.jsp.
[4]Patent Trial and Appeal Board.Inter Partes Review[EB/OL].[2017-03-28].https://www.uspto.gov/patents-applicationprocess/appealing-patent-decisions/trials/inter-partes-review.
[5]Patent Trial and Appeal Board.Search PTAB[EB/OL].[2017-03-28].https://ptab.uspto.gov/#/login.
[6]美国法典[S].第35卷.第314(a)节.
[7]林淘曦,余娜,黄璐.美国首仿药制度及专利挑战策略研究[J].中国新药杂志,2016,25(19):2168-2173.
[8]麦丽谊,陈昕,安金蒙,等.美国仿制药申请中应注意的问题及对我国的启示[J].今日药学,2017,27(10):675-682.
[9]纪媛媛,周东明.从知识产权角度浅析仿制药企业的发展之道[J].中国新药杂志,2016,25(11):1212-1215.