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 Collection: Congressional Research Service Reports
Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Description: 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.
Contributing Partner: UNT Libraries Government Documents Department
Follow-On Biologics: The Law and Intellectual Property Issues

Follow-On Biologics: The Law and Intellectual Property Issues

Date: January 15, 2014
Creator: Thomas, John R.
Description: This report reviews the Biologics Price Competition and Innovation Act of 2009 (BPCIA), within the context of intellectual property and innovation issues. It provides an introduction to the biologics industry, introduces the regulatory and intellectual property provisions of the BPCIA, considers the potential market for biosimilars and possible industry responses that may arise in the wake of this legislation, and closes with concluding observations.
Contributing Partner: UNT Libraries Government Documents Department
The GATT and the WTO: An Overview

The GATT and the WTO: An Overview

Date: March 27, 1995
Creator: Wilson, Arlene
Description: The Uruguay Round Agreement reduced tariffs, brought services, intellectual property, and agriculture under the discipline of the General Agreement on Tariffs and Trade, and established the World Trade Organization. Multilateral trade issues for the future include continuing services negotiations, the relationship of the environment and labor standards to trade, and investment and competition policy.
Contributing Partner: UNT Libraries Government Documents Department
Genetically Engineered Soybeans: Acceptance and Intellectual Property Rights Issues in South America

Genetically Engineered Soybeans: Acceptance and Intellectual Property Rights Issues in South America

Date: October 17, 2003
Creator: Schnepf, Randy
Description: This report discusses issues regarding genetically engineered soybeans in South America. U.S. soybean growers and trade officials charge that Argentina and Brazil–the United States’ two major export competitors in international soybean markets–gain an unfair trade advantage by routinely saving genetically-engineered (GE), Roundup Ready (RR) soybean seeds from the previous harvest (a practice prohibited in the United States) for planting in subsequent years.
Contributing Partner: UNT Libraries Government Documents Department
Geographical Indications and WTO Negotiations

Geographical Indications and WTO Negotiations

Date: July 14, 2003
Creator: Hanrahan, Charles E
Description: This report discusses the issue of expanding intellectual property protections for geographical indications for wines, spirits, and agricultural products is being debated in the World Trade Organization (WTO).
Contributing Partner: UNT Libraries Government Documents Department
The Google Book Search Project: Is Online Indexing a Fair Use Under Copyright Law?

The Google Book Search Project: Is Online Indexing a Fair Use Under Copyright Law?

Date: December 28, 2005
Creator: Jeweler, Robin
Description: This report provides background on the pending litigation. Google, Inc. is digitally scanning the collections of several prominent libraries in order to create a vast searchable database of literary works. Copyright holders who have not authorized and object to the digitization have filed suit against the company.
Contributing Partner: UNT Libraries Government Documents Department
The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

Date: May 5, 2010
Creator: Manuel, Kate M.
Description: In December 2004, Google announced its Library Project, which was to entail digitizing, indexing, and displaying "snippets" of print books in the collections of five major libraries, among other things. The Library Project was not limited to books in the public domain (e.g., books whose terms of copyright protection had expired), and Google did not seek the permission of copyright holders, in part, because it asserted that its proposed uses were fair uses. Many authors, publishers, and other rights holders disagreed. This report provides background on the Library Project, legal issues raised by digitization and indexing projects, and the status of the litigation over the Library Project.
Contributing Partner: UNT Libraries Government Documents Department
The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

Date: November 27, 2009
Creator: Manuel, Kate M.
Description: In December 2004, Google announced its Library Project, which was to entail digitizing, indexing, and displaying "snippets" of print books in the collections of five major libraries, among other things. The Library Project was not limited to books in the public domain (e.g., books whose terms of copyright protection had expired), and Google did not seek the permission of copyright holders, in part, because it asserted that its proposed uses were fair uses. Many authors, publishers, and other rights holders disagreed. This report provides background on the Library Project, legal issues raised by digitization and indexing projects, and the status of the litigation over the Library Project.
Contributing Partner: UNT Libraries Government Documents Department
The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

The Google Library Project: Is Digitization for Purposes of Online Indexing Fair Use Under Copyright Law?

Date: July 6, 2009
Creator: Manuel, Kate M.
Description: The Google Book Search Library Project, announced in December 2004, raised important questions about infringing reproduction and fair use under copyright law. Google planned to digitize, index, and display "snippets" of print books in the collections of five major libraries without the permission of the books' copyright holders, if any. Google's proposed reproduction and display of copyrighted books was not authorized by the rights holders, who alleged that the Google Library Project infringed their copyrights. This report provides background on the Library Project, legal issues raised by digitization and indexing projects, and the proposed settlement.
Contributing Partner: UNT Libraries Government Documents Department
H.R. 1417: The Copyright Royalty and Distribution Reform Act of 2004

H.R. 1417: The Copyright Royalty and Distribution Reform Act of 2004

Date: March 8, 2004
Creator: Jeweler, Robin
Description: None
Contributing Partner: UNT Libraries Government Documents Department