专利药品平行进口:美国法律、中国立场及法制重构  

Parallel Import of Patented Drugs:US Law,Chinese Position,and Legal Restructuring

作　　者：闫海[1] 张华琴 YAN Hai;ZHANG Hua-qin(Law School,Liaoning University,Shenyang 110136 China)

机构地区：[1]辽宁大学法学院,辽宁沈阳110136

出　　处：《青海师范大学学报（哲学社会科学版）》2020年第2期35-40,共6页Journal of Qinghai Normal University(Philosophy and Social Sciences Edition)

基　　金：辽宁省高等学校创新团队及创新人才支持计划“基于药品可及性的我国药事法治研究”(辽教函[2019]432号)。

摘　　要：专利药品平行进口涉及宏观上药品研发能力较强的发达国家与研发能力较弱的发展中国家的利益冲突,亦在微观上体现为药品专利权人、平行进口商及患者间的利益冲突,是中美经贸协议实施以及后续谈判的关键问题。美国制定法关于专利药品平行进口规定较为模糊,判例法则从国际权利穷竭原则、修正的国际权利穷竭原则,转至国内权利穷竭原则的适用,并且对相关国际法产生了重大影响。专利药品平行进口对我国影响有利有弊,因此,我国相关法制应当持有限度的允许立场,并且从合同中的限制性条款、专利药品平行进口的有限许可及平行进口商的法律义务三个方面予以法制重构。Parallel import of patented drugs involves the conflict of interest between developed countries with stronger drug R&D capability and developing countries with weaker R&D capability in macro level,and also embodies the conflict of interest among drug patentees,parallel importers and patients in micro level,which is the key issue for the implementation of Sino US economic and trade agreement and subsequent negotiations.The regulations of parallel import of patented drugs in American statute law are vague.The case law changes from the exhaustion principle of international rights and the revised exhaustion principle of international rights to the application of the exhaustion principle of domestic rights,and has a significant impact on the relevant international law.Parallel import of patented drugs has both advantages and disadvantages to our country,so the relevant legal system of our country should hold the position of limited permission,and reconstruct the legal system from three aspects:the restrictive clause in the contract,the limited license of parallel import of patent drugs and the legal obligation of parallel importers.

关 键 词：专利药品 平行进口 权利穷竭 有限许可 平行进口商 

分 类 号：D923.42[政治法律—民商法学]