Research Use Exemptions to Patent Infringement for Drug Discovery and Development in the United States

被引：8

作者：

Russo, Alicia A. ^{[1
]}

Johnson, Jason ^{[1
]}

机构：

[1] Fitzpatrick Cella Harper & Scinto, New York, NY 10104 USA

来源：

COLD SPRING HARBOR PERSPECTIVES IN MEDICINE | 2015年 / 5卷 / 02期

关键词：

D O I：

10.1101/cshperspect.a020933

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Experiments with patented compounds or processes are sometimes necessary for Food and Drug Administration approval of a small-molecule drug, biologic, or medical device. The law exempts certain research and development activities using these patented compounds or processes. The two exemptions are (1) a judicially created exemption developed through case law and (2) an exemption created by the Hatch-Waxman Act (the "safe harbor" provision). This article analyzes the history of these exemptions and how the courts have interpreted their scope and provides future perspectives on protecting research and development activities from liability.

引用

页数：10