Follow-On Biologics : the law and intellectual property issues / John R. Thomas.

Format:

Book

Author/Creator:

Thomas, John R., author.

Contributor:

Library of Congress. Congressional Research Service, issuing body.

Series:

CRS report for Congress

Language:

English

Subjects (All):

Biotechnology--Law and legislation.

Biotechnology.

Physical Description:

1 online resource (21 pages).

Updated irregularly

Edition:

[Library of Congress public edition].

Place of Publication:

Washington, District of Columbia : Congressional Research Service, 2014.

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:

The CRS report home page provides access to all versions published since 2018 in accordance with P.L. 115-141; earliest version dated 2014.

"Updated January 15, 2014."

Report includes bibliographical references.

Description based on publisher supplied metadata and other sources.

OCLC:

1111801563