Franklin

Follow-On Biologics [electronic resource] : The Law and Intellectual Property Issues.

Author/Creator:
Library of Congress. Congressional Research Service. Resources, Science, and Industry Division.
Publication:
[S.l] : [s.n.], 2012.
Format/Description:
Government document
Book
1 online resource (1 online resource (23 p), digital, PDF file)
Status/Location:
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Subjects:
Biotechnology.
Competition.
Information services.
Intellectual property.
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 Apr. 2014). Reuse except for individual research requires license from ProQuest, LLC.
CRS Report.
Other format:
Microfiche version: Library of Congress. Congressional Research Service. Resources, Science, and Industry Division. Follow-On Biologics
Access Restriction:
Restricted for use by site license.