摘要
美国于1984年通过Hatch-Waxman法案在全球首次建立了药品专利链接制度,其中第IV段专利挑战和30个月"停摆期"构成了这一制度的核心基础。通过第IV段挑战,仿制药企业可以寻求在专利到期前上市仿制药。但是,30个月"停摆期"也会被专利权人用于推迟仿制药竞争,从而延长其市场独占期。本文对美国第IV段专利挑战及其诉讼相关实践情况进行分析,并在此基础上对我国药品专利链接制度的设计提出了具体建议。
By the 1984 Hatch-Waxman Act, the US established, for the first time, patent linkage system in the world. Paragraph IV "Patent Challenge" and the 30-Month Stay constitute the core foundation of this system. Through paragraph IV Patent Challenge, generic manufacturers can seek to market their generic drugs before the patent expires. But the 30-Month Stay could be used by patent holders to delay generic competition, thereby extending the period of their monopoly over the market. The paper, based on the analysis of the practice of Paragraph IV Patent Challenge and litigation in the USA, presents specific suggestions for the future establishment of drug patent linkage system in China.
出处
《知识产权》
CSSCI
北大核心
2018年第12期87-93,共7页
Intellectual Property
关键词
专利链接
第Ⅳ段挑战
停摆期
药品
patent linkage
patagraphⅣpatent challenge
30-Month Stay
pharmaceuticals
