期刊论文

Rationalization and Institutional Construction of Artificial Infringement of Generic Drug Patent Challenge

中文

中国科技论坛

1002-6711

2023

CSSCI

04

142-150+157

国家社会科学基金后期资助项目“数字经济下的创新政策组合理论与实证研究”(18FGL001)；

本校为第一机构

仿制药专利挑战是药品专利链接制度的核心内容，也是药品注册审批阶段引发专利权属争议的主要制度动因。当前，关于专利挑战行为法律属性的界定存在争议，拟制侵权与确认不侵权两种观点各执一端。前者以法律拟制和知识产权侵权促成事由为理论基础，并具有平衡内外部利益的功能，在逻辑结构标准与同一法益标准的审视下，拟制侵权与Bolar豁免构成一般法与特别法的关系。通过分析与借鉴美韩专利挑战相关立法，建议中国引入拟制侵权，在立法层面确认仿制药专利挑战为拟制侵权的同时将其作为Bolar豁免的特别规定。针对拟制侵权的权利扩张风险，采取限缩路径明确其司法管辖的专利声明类型、客体范围及...

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 th...MORE 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 ...