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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.
Item Type: Report
Partner: UNT Libraries Government Documents Department

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

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.
Date: July 6, 2009
Creator: Manuel, Kate M.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Copyright Protection for Fashion Design: A Legal Analysis of the Design Piracy Prohibition Act (H.R. 2196)

Description: Fashion design does not currently receive explicit protection under U.S. copyright law. This report analyzes the amendments that the Design Piracy Prohibition Act would make to the Copyright Act to provide for fashion design protection. It also summarizes arguments both in favor of and against extending such protection.
Date: June 1, 2009
Creator: Yeh, Brian T.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Intellectual Property Rights and Access to Medicines: International Trade Issues

Description: This report focuses on the relationship between intellectual property right (IPR) provisions in international and U.S. trade policy and access to medicines. This issue represents one component of a broader debate about the relationship between trade policy and public health.
Date: May 28, 2009
Creator: Ilias, Shayerah
Item Type: Report
Partner: UNT Libraries Government Documents Department

Patent Reform in the 111th Congress: Innovation Issues

Description: This study provides an overview of current patent reform issues. It begins by offering a summary of the structure of the current patent system and the role of patents in innovation policy. The report then reviews some of the broader issues and concerns, including patent quality, the high costs of patent litigation, international harmonization, and speculation in patents, that have motivated these diverse legislative reform proposals.
Date: April 9, 2009
Creator: Schacht, Wendy H. & John R. Thomas
Item Type: Report
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.
Item Type: Report
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.
Item Type: Report
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: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents

Description: This report provides information describing the federal civil remedies and criminal penalties that may be available as a consequence of violations of the federal intellectual property laws: the Copyright Act of 1976, the Patent Act of 1952, and the Trademark Act of 1946 (conventionally known as the Lanham Act).
Date: October 31, 2008
Creator: Yeh, Brian T.
Item Type: Report
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.
Item Type: Report
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: July 23, 2008
Creator: Ilias, Shayerah & Fergusson, Ian F.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Description: This report identifies several current issues relating to intellectual property in industrial designs. It begins by describing the different sorts of intellectual property protection that apply to industrial designs. The report then identifies current issues at the interface between intellectual property and industrial designs. The report closes by reviewing the impact that sui generis rights regimes may have upon innovation and competition in the United States.
Date: July 1, 2008
Creator: Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Innovation and Intellectual Property Issues in Homeland Security

Description: This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Date: January 17, 2008
Creator: Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Influenza Antiviral Drugs and Patent Law Issues

Description: This report examines the role that intellectual property rights play in affecting the availability of a patented drug such as Tamiflu during public health crises. The report also explains one legal mechanism for increasing a patented drug’s production without the patent holder’s consent: governments may abrogate a pharmaceutical company’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of the drug.
Date: August 16, 2007
Creator: Yeh, Brian T.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: June 1, 2007
Creator: Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Exporting Software and the Extraterritorial Reach of U.S. Patent Law: Microsoft Corp. v. AT&T Corp.

Description: Generally speaking, United States patent law does not have extraterritorial effect. The exception, however, is § 271(f) of the Patent Act, which makes it an act of patent infringement to manufacture within the United States the components of a patented invention and then export those disassembled parts for combination abroad into an end product. This report discusses Microsoft Corp. v. AT&T Corp. (550 U.S. ___ , No. 05-1056, decided April 30, 2007), in which the U.S. Supreme Court held that software companies are not liable for patent infringement under § 271(f) when they export software that has been embodied in machine-readable, physical form (a CD-ROM, for example), with the intent that such software be copied abroad for installation onto foreign-manufactured computers.
Date: May 31, 2007
Creator: Yeh, Brian T.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Innovation and Intellectual Property Issues in Homeland Security

Description: This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Date: January 17, 2007
Creator: Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Patents and Drug Importation

Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Date: January 17, 2007
Creator: Thomas, John R.
Item Type: Report
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.
Item Type: Report
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.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Gene Patents: A Brief Overview of Intellectual Property Issues

Description: This report is a brief discussion of the ethical, legal, and economic issues of gene patenting. The courts have upheld gene patents that meet the criteria of patentability defined by the Patent Act. However, the practice of awarding patents on genes has come under intense scrutiny by some scientists, legal scholars, politicians, and other experts.
Date: October 3, 2006
Creator: Schacht, Wendy H.
Item Type: Report
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.
Item Type: Report
Partner: UNT Libraries Government Documents Department

Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Description: Congressional interest in the development of bioterrorism countermeasures remains strong, even after passage of legislation establishing Project BioShield. In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, S. 975, the Project Bioshield II Act, and S. 1873, the Biodefense and Pandemic Vaccine and Drug Development Act, that would generate additional incentives for the creation of new technologies to counteract potential biological threats. These bills propose reforms to current policies and practices associated with intellectual property, particularly patents, and the marketing of pharmaceuticals and related products.
Date: January 17, 2006
Creator: Schacht, Wendy H. & Thomas, John R.
Item Type: Report
Partner: UNT Libraries Government Documents Department