Follow-On Biologics The Law and Intellectual Property Issues

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service. Resources, Science, and Industry Division

Language:

English

Subjects (All):

Biotechnology.

Information services.

Technological innovations.

Physical Description:

1 online resource

Contained In:

ProQuest U.S. Congressional Research Digital Collection

Place of Publication:

[United States] [publisher not identified] 2011

Summary:

Reviews intellectual property and innovations issues within context of the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which established expedited licensor pathway for competing versions of previously marketed biologics; created FDA-administered periods of data protection and marketing exclusivity for certain brand-name drugs and follow-on products; and provided a patent dispute resolution procedure for use by brand-name and follow-on biologic manufacturers. Provides introduction to biologics industry, which includes biotechnology and biopharmaceutical industries; reviews regulatory and intellectual property provisions of BPCIA; and considers potential market for biosimilars and possible responses that may arise in wake of this legislation

Notes:

CRS Report

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Jan. 2013). Reuse except for individual research requires license from ProQuest, LLC

Vendor supplied data

Other Format:

Microfiche version Library of Congress. Congressional Research Service. Resources, Science, and Industry Division. Follow-On Biologics

Publisher Number:

CRS-2011-RSI-0722

Access Restriction:

Restricted for use by site license