Follow-On Biologics. : The Law and Intellectual Property Issues.

Format:

Book

Government document

Author/Creator:

Library of Congress. Congressional Research Service.

Language:

English

Subjects (All):

Biotechnology.

Competition.

Information services.

Physical Description:

1 online resource (23 pages, digital, PDF file)

Place of Publication:

[Place of publication not identified] : [publisher not identified], 2010.

System Details:

text file

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:

Record is based on bibliographic data in ProQuest U.S. Congressional Research Digital Collection (last viewed Sept. 2012). Reuse except for individual research requires license from ProQuest, LLC.

CRS Report.

Other Format:

Microfiche version: Library of Congress.Congressional Research Service. Follow-On Biologics

Access Restriction:

Restricted for use by site license.