Abstract：China is currently moving from a major pharmaceutical country towards a pharmaceutical powerhouse.In this period,it has become a significant issue to encourage drug innovation and the generic drugs production,so as to form a large joint governance of drug patents.The new Chinese Patent Law has established an early settlement mechanism for drug patent disputes,and also a drug patent validity period compensation system as a supporting system for the drug patent linkage system.This fully reflects the value orientation of the system:to ensure the balance of interests among innovative pharmaceutical companies,generic pharmaceutical companies and the public,as well as the value orientation to improve efficiency and avoid resources waste.There are still several deficiencies in the drug patent linkage system established in the new Patent Law,such as unspecified scope of the“relevant patent rights”,controversial“opposition period”and“waiting period”,inadequate exclusivity period system of the first generic drug,and the incomplete compensation mechanism for the effective period of drug patents.In promoting the implementation of the drug patent linkage system,it is recommended to define the scope of patent rights,further improve the disclosure of patent information,standardize the declaration procedures for drug patent declarations,reasonably set the waiting period for chemical drugs,and improve the exclusive period system for the first generic drug.
李晓秋, 余晨. 论新《专利法》中药品专利链接制度的确立及完善[J]. 中国科技论坛, 2022(1): 131-138.
Li Xiaoqiu, Yu Chen. On the Establishment and Improvement of the Drug Patent Linkage System in the New “Patent Law”. , 2022(1): 131-138.
[1] 俞风雷.知识产权保护中的利益平衡理论及其制度构建——以中国药品专利链接制度为例[J].求索,2019(6):82-87. [2] 邱福恩.美国药品专利链接制度实践情况及其启示[J].知识产权,2018(12):87-93. [3] 梁志文.专利质量的司法控制[J].法学家,2014(3):61-73,178. [4] 张清奎.医药及生物技术领域知识产权战略实务[M].北京:知识产权出版社,2008:297. [5] 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. [6] 李想.医药专利链接制度运行机理研究[J].电子知识产权,2019(3):13-21. [7] 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. [8] 张浩然.竞争视野下中国药品专利链接制度的继受与调适[J].知识产权,2019(4):50-70. [9] GRABOWSKI H,LONG G,MORTIME R,et al.Updated trends in US brand-name and generic drug competition[J].Journal of medical economics,2016,19(9):836-844. [10] 邱福恩.韩国药品专利链接制度介绍及对中国制度的启示[J].电子知识产权,2019(3):22-28. [11] 闫海,王洋,马海天,等.基于药品可及性的专利法治研究[M].北京:法律出版社,2020. [12] 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. [13] 程永顺,吴莉娟.创新与仿制的平衡与发展——评Hatch-Waxman法案对美国医药产业的贡献[J].科技与法律,2018(1):1-9. [14] 相靖.美国药品专利反向支付问题的反垄断法规制研究[J].知识产权,2019(11):87-96. [15] PANATTONI L E.The effect of paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms[J].Journal of health economics,2011,30(1):126-145. [16] 徐非.认真对待药品专利链接制度[EB/OL].(2020-03-14)[2020-04-10].http://www.cnpharm.com/c/2020-03-14/715444.shtml. [17] 邰红,韦嵥.中国药品专利链接制度初探[EB/OL].(2020-12-15)[2021-01-25].https://mp.weixin.qq.com/s/uMRe7xh_Ud3Sgwwts9btHQ. [18] SON K B,BAE S J,LEE T J.Does the patent linkage system prolong effective market exclusivity? Recent evidence from the Korea-U.S.free trade agreement in Korea[J].International journal of health services,2019,20(7314):306-321. [19] 巩雪,刘海兵.企业技术创新能力与开放式创新策略选择[J].中国科技论坛,2020(12):54-66. [20] 王浩群.专利链接展望一:从“第一阶段经贸协定”到“专利信息申报登记”[EB/OL].(2020-02-20)[2020-04-10].https://baijiahao.baidu.com/s?id=1659071609568710581&wfr=spider&for=pc. [21] HEMPHILL C S,SAMPAT B N.When do generics challenge drug patents[J].Journal of empirical legal studies,2011,8(4):613-649. [22] DWIVEDI G,HALLIHOSUR S,RANGAN L.Evergreening:a deceptive device in patent rights[J].Technology in society,2010,32(4):324-330. [23] 李红团.构建合乎国情的药品专利链接制度[J].中国新药杂志,2018,27(17):1953-1963. [24] 程永顺,吴丽娟.实施“药品专利链接制度”司法应当考虑解决的问题[EB/OL].(2020-04-04)[2020-04-10].https://baijiahao.baidu.com/s?id=1662945847410815584&wfr=spider&for=pc. [25] 吴丽丽,雷娟,张琳琳.药品专利链接相关法律一览:掀开面纱的中国药品专利链接制度[EB/OL].(2020-12-21)[2021-01-25].https://mp.weixin.qq.com/s/zlvE4tdXXQpcbkLBbTizOA. [26] SON K B,LOPERT R.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):101-101.
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