|
|
|
| Rationalization and Institutional Construction of Artificial Infringement of Generic Drug Patent Challenge |
| Feng Zhenlong, Zhou Ying |
| Institute of Intellectual Property, School of Law, Central China Normal University, Wuhan 430070, China |
|
|
|
|
Abstract Generic drug patent challenge is the core content of the drug patent linkage system and the main institutional motivation triggering disputes over patent ownership during the drug registration and approval stage.Currently, there is a controversy over the definition of the legal attributes of patent challenge, with the two views of artificial infringement and confirmed non-infringement spilt on each end.The former is based on the theory of legal fiction and contributory cause of intellectual property infringement, and has the function of balancing internal and external interests.Under the examination of the logical structure standard and the same legal interests standard, the artificial infringement and the Bolar exemption have formed a relationship of general law with special law.By analyzing and learning from the relevant legislation of patent challenge in the US and Korean, it is recommended that China introduce artificial infringement, confirm the generic drug patent challenge as artificial infringement in legislation and add it as the special provision of the Bolar exemption.In response to the risk of rights expansion of artificial infringement, a restrictive path should be adopted to clarify the types of patent declarations, the scope of objects and legal consequences under its jurisdiction.At the same time, the CFDA should be endowed with the authority to verify the waiting period and perfect the regulatory measures for the above.
|
|
Received: 06 June 2022
|
|
|
|
|
|
[1]王艳,胡允银.制药行业产品跳跃:垄断还是创新[J].科技管理研究,2017,37(11):23-27.
[2]牛剑钊,林兰,马锐,等.中国仿制药研究及监管现状[J].中国新药杂志,2014,23(1):6-10.
[3]苏冬冬.药品专利链接制度的正当性及制度价值分析[J].电子知识产权,2019(3):4-12.
[4]陈烨,丁锦希.药品集中带量采购中的专利问题探讨[J].知识产权,2021(9):79-96.
[5]郑淑凤.专利链接中拟制侵权的理论基础与实施问题[J].电子知识产权,2019(12):83-94.
[6]丁锦希,韩蓓蓓.中美药品专利链接制度比较研究[J].中国医药工业杂志,2008,39(12):950-955.
[7]HARKINS C A.A budding theory of willful patent infringement:orange books,colored pills,and greener verdicts[J].Duke law and technology review 2007,6(8):6.
[8]药监局.什么是专利药、原研药、仿制药[EB/OL].(2017-10-24)[2022-05-06].https://www.nmpa.gov.cn/xxgk/kpzhsh/kpzhshyp/20171024171601233.html.
[9]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(10):30-41.
[10]苏冬冬.药品专利链接制度建构的中国方案:理论、原则与路径[J].科技进步与对策,2022,39(6):121-129.
[11]占善刚,张一诺.知识产权确认不侵权之诉受理条件实证研究[J].知识产权,2020(3):27-46.
[12]谢潇.罗马私法拟制研究[J].比较法研究,2017(3):155-179.
[13]宁立志.我国“Bolar例外规则”的学理解构与制度重建[J].政法论丛,2019(2):46-56.
[14]何培育.知识产权侵权促成性事由探究[J].法商研究,2011,28(1):88-94.
[15]刘友华,隆瑾,徐敏.“专利悬崖”背景下制药业的危机及我国的应对[J].湘潭大学学报(哲学社会科学版),2015,39(6):80-84.
[16]徐蔾风.专利权的限制与扩张[M].北京:知识产权出版社,2007.
[17]吴柯苇.仿制药专利挑战机制解释学分析与进路选择[J].科技进步与对策,2021,38(1):79-86.
[18]陈运生.法律冲突解决的方法论[M].北京:中国政法大学出版社,2017.
[19]杨登峰.选择适用一般法与特别法的几个问题[J].宁夏社会科学,2008(3):19-23.
[20]卡尔·拉伦茨.法学方法论[M].陈爱娥,译.北京:商务印书馆,2003.
[21]WEISWASSER E S,DANZIS S D.The Hatch-Waxman act:history,structure,and legacy[J].Antitrust law journal,2003,71(2):585-608.
[22]LEVINE H W,CHARLES E L,SANYA S,et al.Inter partes review in generic drug litigation-why the USPTO should exercise its discretion to deny IPR petitions inappropriate Hatch-Waxman act disputes[J].Pharmaphorum,2014,7(3):1-21.
[23]杨婧,曹丽荣.美国药品专利纠纷早期解决机制及其对中国的启示[J].中国新药杂志,2021,30(16):1441-1450.
[24]SON K B,LOPERT R,GLEESON D,et al.Moderating the impact of patent linkage on access to medicines:lessons from variations in South Korea,Australia,Canada,and the United States[J].Globalization and health,2018,14(1):1-11.
[25]邱福恩.韩国药品专利链接制度介绍及对我国制度的启示[J].电子知识产权,2019(3):22-28. |
|
|
|
2023, Vol. 4 
