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| Patent Challenge Mechanism of Generics: Legal Interpretation and Approach Analysis |
| Wu Kewei |
| (School of Law,Peking University,Beijing 100871, China) |
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Abstract The generic patent challenge mechanism is the core of the pharmaceutical patent link system.While the construction of generic patent challenge mechanism under the existing norm system may be a conflict with the current Patent Law, it is necessary to resolve such dispute through legislation or legal interpretation.Under the paradigm of statutory interpretation, the two legislative approaches to the infringement interpretation of generic patent challenges are deduced and reflected, supplemented by the perspectives of institutional systems, international obligations, legal policies, and law and economics.The holding is that the approach of legal fiction is more feasible.In the system construction under the proposed method, the technical norms of legal fiction should be emphasized, and the supporting system should be properly handled.
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Received: 13 December 2019
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[1] 吴柯苇.仿制药专利挑战行为界定与属性分析——以药品专利链接制度本土化为背景[J].电子知识产权,2019，30(10):30-41.
[2] 崔国斌.知识产权法官造法批判[J].中国法学,2006，23(1):144-164.
[3] 易继明.知识产权法定主义及其缓和——兼对《民法总则》第123条条文的分析[J].知识产权,2017，31(5):3-11.
[4] 崔国斌.专利法：原理与案例[M].北京:北京大学出版社，2016:16-17.
[5] 李扬.法政策学视点下的知识产权法[M].北京：知识产权出版社,2017:23-40.
[6] 张清奎.加强医药创新的专利保护 改善发展不平衡的政策环境[J].中国发明与专利,2018,15(4):30-36.
[7] 梁慧星.民法解释学[M].北京:法律出版社，2015:191-193.
[8] 史尚宽.民法总论[M].台北:正大印书馆，1970:38.
[9] 杨仁寿.法学方法论（第2版）[M].北京:中国政法大学出版社，2013:123-166.
[10] 王泽鉴.民法思维:请求权基础理论体系[M].北京:北京大学出版社,2009:154-157,225.
[11] 黄茂荣.法学方法与现代民法[M].北京:中国政法大学出版社,2001:301.
[12] 朱庆育.民法总论(第2版)[M].北京:北京大学出版社，2016:38,42,48-49,50-57.
[13] 宋婷.论知识产权侵权归责原则[A]//Information engineering research institute, USA、singapore management and sports science institute, singapore.proceedings of 2017 6th international conference on applied social science (ICASS 2017) V98[C].Information Engineering Research Institute, USA、Singapore Management and Sports Science Institute, Singapore:智能信息技术应用学会,2017:6.
[14] 尹新天.中国专利法详解[M].北京:知识产权出版社,2014:820,834-837.
[15] 程永顺,吴莉娟.中国药品专利链接制度建立的探究[J].科技与法律,2018，31(3):1-10.
[16] SHASHANK UPADHYE.Understanding patent infringement under 35 U.S.C.271(e): the collisions between patent[J].Medical Device and Drug Laws, 17 Santa Clara High Tech.L.J.1 (2000).
[17] 卢鹏.拟制问题研究[M].上海:上海人民出版社, 2009:156.
[18] [德]卡尔·拉伦茨.法学方法论[M].陈爱娥,译, 北京:商务印书馆，2003:137-144.
[19] FULLER, LON L.Legal fictions[M].United States: Stanford University Press, 1967:5.
[20] 赵春玉.法律拟制的语义内涵及规范构造[J].思想战线,2016,42(5):167-172.
[21] 薛波.元照英美法大辞典[M].北京:北京大学出版社,2014:548.
[22] 卢鹏.论结论性推定与拟制的区别[J].同济大学学报(社会科学版),2003，14(1):63-68.
[23] 赵春玉.法律拟制正当性的诠释学思考[J].北大法律评论,2016,17(1): 65-86.
[24] 刘强.法律拟制、机会主义行为与知识产权制度研究[J].西部法学评论,2015，26(5):1-10.
[25] 张玉敏,李雨峰,张耕.知识产权法学[M].北京:法律出版社,2016:21.
[26] 郑成思.知识产权 应用法学与基本理论[M].北京:人民出版社,2005:271-276.
[27] 亚里士多德.形而上学[M].吴寿彭译，北京:商务印书馆,1983:159.
[28] LLEWELLYN K. What price contract?an essay in perspective[J].The Yale Law Journal,1931,40(5):704-751.
[29] EISENBERG M A.The nature of the common law[M].United Kingdom: Harvard University Press,1991:149.
[30] 梁志文.美国自由贸易协定中药品TRIPS-Plus保护[J].比较法研究,2014，28(1):125-140.
[31] 张伟君,陈滢.论药品专利链接制度与现行《专利法》的衔接[J].中国发明与专利,2018,15(3):40-46.
[32] 梁志文.药品专利链接制度的移植与创制[J].政治与法律,2017，36(8):104-114.
[33] USTR.Special 301 Report [R/OL].[2017-04-01].https:https://ustr.gov/sites/default/files/301/2017%20Special%20301%20Report%20FINAL.PDF：p.33.Last visit at May 5, 2020.
[34] LANDES W, POSNER R.Trademark law: an economic perspective[J].The Journal of Law & Economics, 1987,30(2):265-309.
[35] 奥利弗·E·威廉姆森.资本主义经济制度[M].北京:商务印书馆，2002:15-16,19-22,31.
[36] 杨悦.我国应建立怎样的专利链接制度及配套制度[J].中国食品药品监管,2018(3):35-40. |
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