Follow-On Biologics: Intellectual Property and Innovation Issues

Schacht, Wendy H. ; Thomas, John R.

Library of Congress. Congressional Research Service.

关键词: Medicine;    Drugs;    Drug industry;    Intellectual property;    Patents;   

RP-ID  :  RL33901
RP-ID  :  RL33901_2009Aug03

美国|英语

来源: UNT Digital Library

【 摘 要 】

This report reviews doctrinal and policy issues pertaining to follow-on biologics. The report first introduces the application of federal food and drug legislation to follow-on biologics. It next turns to the patent implications of marketing follow-on biologics. Following this review of substantive law, the remainder of the report introduces innovation policy issues pertaining to follow-on biologics.