Congressional Research Service Reports - 99 Matching Results

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Follow-On Biologics: The Law and Intellectual Property Issues

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.
Date: January 15, 2014
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

False Patent Marking: Litigation and Legislation

Description: This report will describe and analyze the Federal Circuit's 2009 decision that requires a per-article penalty for false marking, as well as two subsequent Federal Circuit decisions in 2010 that answer several questions that have arisen during the recent false patent marking litigation. It also identifies and discusses legislation in the 111th Congress that would amend § 292 in order to retroactively end qui tam false marking suits and with the intent of reducing the number of false marking suits filed in the future.
Date: September 20, 2010
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

False Patent Marking: Litigation and Legislation

Description: This report will describe and analyze the Federal Circuit's 2009 decision that requires a per-article penalty for false marking, as well as two subsequent Federal Circuit decisions in 2010 that answer several questions that have arisen during the recent false patent marking litigation. It also identifies and discusses legislation in the 111th Congress that would amend § 292 in order to retroactively end qui tam false marking suits and with the intent of reducing the number of false marking suits filed in the future.
Date: October 20, 2010
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

Follow-On Biologics: Intellectual Property and Innovation Issues

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.
Date: August 3, 2009
Creator: Schacht, Wendy H. & Thomas, John R.
Partner: UNT Libraries Government Documents Department

Qui Tam: An Abbreviated Look at the False Claims Act and Related Federal Statutes

Description: This is a brief discussion of the constitutional questions raised by qui tam provisions; of the history of such provisions; and of the three existing, active federal qui tam statutes--the False Claims Act, 31 U.S.C. 3729-3733; the false marking patent statute, 35 U.S.C. 292; and the Indian protection provisions of 25 U.S.C. 201.
Date: August 6, 2009
Creator: Doyle, Charles
Partner: UNT Libraries Government Documents Department

An Overview of the "Patent Trolls" Debate

Description: This report reviews the current debate and controversy surrounding "patent assertion entities" (PAEs) and their effect on innovation, examines the reasons for the rise in PAE litigation, and explores the legislative options available to Congress if it decides that these are issues that should be addressed.
Date: August 20, 2012
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

Geographical Indications and WTO Negotiations

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).
Date: July 14, 2003
Creator: Hanrahan, Charles E.
Partner: UNT Libraries Government Documents Department

Intellectual Property Rights and International Trade

Description: This report discusses the different kinds of intellectual property rights (IPR); forms of IPR infringement; importance of IPR to the U.S. economy; estimated losses associated with IPR infringement; organizational structure of IPR protection in multilateral, regional, bilateral; U.S. government agencies involved with IPR and trade; and issues for Congress regarding IPR and international trade.
Date: October 20, 2008
Creator: Ilias, Shayerah & Fergusson, Ian F.
Partner: UNT Libraries Government Documents Department

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Date: November 4, 2008
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Description: This report introduces and analyzes innovation policy issues concerning pharmaceutical patent litigation settlements, including pharmaceutical patent litigation procedures under the Hatch-Waxman Act, the concept of reverse payment settlements, the status of reverse payment settlements under the antitrust laws, and congressional issues and alternatives.
Date: January 20, 2011
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping

Description: This report introduces and analyzes innovation and competition policy issues associated with the pharmaceutical industry. It begins with a review of the Hatch-Waxman Act and its implications upon the availability of generic substitutes for brand-name medications. The report then turns to a basic review of the antitrust law. It then addresses judicial developments with respect to reverse payment settlements and product hopping. The report closes with a summary of congressional issues and possible alternatives.
Date: October 7, 2015
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology

Description: This report discusses the rationale behind the passage of P.L. 96-517 (Amendments to the Patent and Trademark Act, or the "Bayh-Dole Act") as well as its provisions and information regarding the implementation of the law. Under this 1980 law, as amended, title to inventions made with government support is provided to the contractor if that contractor is a small business, a university, or other non-profit institution.
Date: February 3, 2009
Creator: Schacht, Wendy H.
Partner: UNT Libraries Government Documents Department

Open Access Publishing and Citatation Archives: Background and Controversy

Description: This report begins with an inventory of basic information: definitions and guides to histories of the growth of open access publishing and citation archives and descriptions of selected major open access activities. It moves on to summarize major points of difference between proponents and opponents of nongovernmental open access publishing and databases, and then highlights federal, including National Institutes of Health (NIH), open access activities and contentious issues surrounding these developments. The report also briefly describes open access developments in the United Kingdom (where a number of governmental and nongovernmental initiatives have occurred) and in the international arena. Finally, controversial issues which could receive attention in the 109th Congress are summarized.
Date: June 22, 2006
Creator: Knezo, Genevieve J.
Partner: UNT Libraries Government Documents Department

Open Access Publishing and Citation Archives: Background and Controversy

Description: This report begins with an inventory of basic information: definitions and guides to histories of the growth of open access publishing and citation archives and descriptions of selected major open access activities. It moves on to summarize major points of difference between proponents and opponents of nongovernmental open access publishing and databases, and then highlights federal, including National Institutes of Health (NIH), open access activities and contentious issues surrounding these developments. The report also briefly describes open access developments in the United Kingdom (where a number of governmental and nongovernmental initiatives have occurred) and in the international arena. Finally, controversial issues which could receive attention in the 109th Congress are summarized.
Date: July 26, 2005
Creator: Knezo, Genevieve J.
Partner: UNT Libraries Government Documents Department

Open Access Publishing and Citation Archives: Background and Controversy

Description: This report begins with an inventory of basic information: definitions and guides to histories of the growth of open access publishing and citation archives and descriptions of selected major open access activities. It moves on to summarize major points of difference between proponents and opponents of nongovernmental open access publishing and databases, and then highlights federal, including National Institutes of Health (NIH), open access activities and contentious issues surrounding these developments. The report also briefly describes open access developments in the United Kingdom (where a number of governmental and nongovernmental initiatives have occurred) and in the international arena. Finally, controversial issues which could receive attention the 110th Congress are summarized.
Date: December 12, 2006
Creator: Knezo, Genevieve J.
Partner: UNT Libraries Government Documents Department

Open Access Publishing and Citation Archives: Background and Controversy

Description: This report begins with an inventory of basic information: definitions and guides to histories of the growth of open access publishing and citation archives and descriptions of selected major open access activities. It moves on to summarize major points of difference between proponents and opponents of nongovernmental open access publishing and databases, and then highlights federal, including National Institutes of Health (NIH), open access activities and contentious issues surrounding these developments. The report also briefly describes open access developments in the United Kingdom (where a number of governmental and nongovernmental initiatives have occurred) and in the international arena. Finally, controversial issues which could receive attention in the 109th Congress are summarized.
Date: October 10, 2006
Creator: Knezo, Genevieve J.
Partner: UNT Libraries Government Documents Department

Open Access Publishing and Citation Archives: Background and Controversy

Description: This report begins with an inventory of basic information: definitions and guides to histories of the growth of open access publishing and citation archives and descriptions of selected major open access activities. It moves on to summarize major points of difference between proponents and opponents of nongovernmental open access publishing and databases, and then highlights federal, including National Institutes of Health (NIH), open access activities and contentious issues surrounding these developments. The report also briefly describes open access developments in the United Kingdom (where a number of governmental and nongovernmental initiatives have occurred) and in the international arena. Finally, controversial issues which could receive attention in the 109th Congress are summarized.
Date: September 12, 2005
Creator: Knezo, Genevieve J.
Partner: UNT Libraries Government Documents Department

"Digital Rights" and Fair Use in Copyright Law

Description: This report examines judicial case law which has considered the doctrine of fair use in relation to the First Amendment, the Digital Millennium Copyright Act, and as a means of protecting private, noncommercial use of digital music and film by consumers. It concludes that when the potential to infringe is great, as it almost always will be in a digital environment, the courts have not been willing to expand fair use to encompass subsidiary uses such as time shifting, space shifting, or personal noncommercial use.
Date: March 24, 2003
Creator: Jeweler, Robin
Partner: UNT Libraries Government Documents Department