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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
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Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Description: Report that identifies several current issues relating to intellectual property in industrial designs. It describes the different sorts of intellectual property protection that apply to industrial designs, and identifies current issues at the interface between intellectual property and industrial designs.
Date: January 5, 2011
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department
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Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine

Description: Report that reviews the Supreme Court's 2012 Mayo Collaborative Services v. Prometheus Laboratories decision (wherein the court held that a patent claiming a method of optimizing therapies for autoimmune disease was invalid) and briefly consider its implications for innovation and public health.
Date: November 6, 2012
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Strategy for Targeting Organized Piracy (STOP) Requires Changes for Long-Term Success

Description: A letter report issued by the Government Accountability Office with an abstract that begins "U.S. government efforts to protect and enforce intellectual property (IP) rights are crucial to preventing billions of dollars in losses and mitigating health and safety risks from trade in counterfeit and pirated goods. These efforts are coordinated through the National Intellectual Property Law Enforcement Coordination Council (NIPLECC), created by Congress in 1999, and the Strategy for Targeting Orga… more
Date: November 8, 2006
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Agencies Progress in Implementing Recent Legislation, but Enhancements Could Improve Future Plans

Description: A letter report issued by the Government Accountability Office with an abstract that begins "Intellectual property (IP) plays a significant role in the U.S. economy. Enforcing IP laws involves many U.S. agencies, making coordination essential. Under the Prioritizing Resources and Organization for Intellectual Property Act of 2008 (PRO-IP Act), Congress required the U.S. Attorney General, through the Department of Justice (DOJ), to devote additional resources and undertake other specific IP effo… more
Date: October 13, 2010
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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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 suit… more
Date: October 20, 2010
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Economic Arrangements Among Small Webcasters and Third Parties and Their Effect on Royalties

Description: A letter report issued by the General Accounting Office with an abstract that begins "The emergence of webcasting as a means of transmitting audio and video content over the Internet has led to concerns about copyright protection and the payment of royalties to those who own the recording copyrights. Arriving at an acceptable rate for calculating royalties has been particularly challenging. Under the Small Webcaster Settlement Act of 2002, small commercial webcasters reached an agreement with c… more
Date: June 1, 2004
Creator: United States. General Accounting Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Key Processes for Managing Patent Automation Strategy Need Stengthening

Description: A letter report issued by the Government Accountability Office with an abstract that begins "The volume and complexity of patent applications to the U.S. Patent and Trademark Office (USPTO) have increased significantly in recent years, lengthening the time needed to process patents. Annual applications have grown from about 185,000 to over 350,000 in the last 10 years and are projected to exceed 450,000 by 2009. Coupled with this growth is a backlog of about 750,000 applications. USPTO has long… more
Date: June 17, 2005
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Assessing Factors That Affect Patent Infringement Litigation Could Help Improve Patent Quality

Description: A letter report issued by the Government Accountability Office with an abstract that begins "From 2000 to 2010, the number of patent infringement lawsuits in the federal courts fluctuated slightly, and from 2010 to 2011, the number of such lawsuits increased by about a third. Some stakeholders GAO interviewed said that the increase in 2011 was most likely influenced by the anticipation of changes in the 2011 Leahy-Smith America Invents Act (AIA), which made several significant changes to the U.… more
Date: August 22, 2013
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Observations on Efforts to Quantify the Economic Effects of Counterfeit and Pirated Goods

Description: A letter report issued by the Government Accountability Office with an abstract that begins "In October 2008, Congress passed the Prioritizing Resources and Organization for Intellectual Property Act of 2008 (PRO-IP Act), to improve the effectiveness of U.S. government efforts to protect intellectual property (IP) rights such as copyrights, patents, and trademarks. The act also directed GAO to provide information on the quantification of the impacts of counterfeit and pirated goods. GAO (1) exa… more
Date: April 12, 2010
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Federal Enforcement Has Generally Increased, but Assessing Performance Could Strengthen Law Enforcement Efforts

Description: A letter report issued by the Government Accountability Office with an abstract that begins "Federal law enforcement actions against criminals who manufacture and distribute counterfeit and pirated goods are important to enforcing intellectual property (IP) rights and protecting Americans from unsafe or substandard products. GAO was asked to: (1) examine key federal agencies' roles, priorities, and resources devoted to IP-related enforcement; (2) evaluate agencies' IP-related enforcement statis… more
Date: March 11, 2008
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: U.S. Trade Policy Guidance on WTO Declaration on Access to Medicines May Need Clarification

Description: A letter report issued by the Government Accountability Office with an abstract that begins "The WTO Agreement on Trade-Related Intellectual Property (TRIPS) requires all 151 World Trade Organization (WTO) members to provide baseline protections, including 20-year patents for innovative pharmaceuticals. The Trade Act of 2002 granting Trade Promotion Authority (TPA) to the President outlined three negotiating objectives related to intellectual property (IP). The first two aim to strengthen IP ri… more
Date: September 28, 2007
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Better Data Analysis and Integration Could Help U.S. Customs and Border Protection Improve Border Enforcement Efforts

Description: A letter report issued by the Government Accountability Office with an abstract that begins "U.S. government efforts to protect and enforce intellectual property rights are crucial to preventing billions of dollars in economic losses and for mitigating health and safety risks from trade in counterfeit and pirated goods. The Department of Homeland Security's Customs and Border Protection (CBP) leads intellectual property (IP) enforcement activity at the U.S. border. GAO was asked to (1) examine … more
Date: April 26, 2007
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Federal Agency Efforts in Transferring and Reporting New Technology

Description: A letter report issued by the General Accounting Office with an abstract that begins "The federal government is a primary sponsor of research conducted in the United States, expending during fiscal year 2001 $19.4 billion for research performed by federal employees and $62.2 billion for research conducted under contracts and grants. Some of this research leads to the development of technology that can be patented, licensed, and made available to the public through the introduction of new produc… more
Date: October 31, 2002
Creator: United States. General Accounting Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Information on the U.S. Patent and Trademark Office's Past and Future Operations

Description: A letter report issued by the General Accounting Office with an abstract that begins "The U.S. Patent and Trademark Office (USPTO) has a staff of 6,426 and collected $1.1 billion in patent and trademark fees in fiscal year 2001. As the U.S. economy depends increasingly on new innovations, the need to patent or trademark quickly the intellectual property resulting from such innovations becomes more important. Expressing concerns about USPTO's plans for the future, Congress directed USPTO to deve… more
Date: August 23, 2002
Creator: United States. General Accounting Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: State Immunity in Infringement Actions

Description: A letter report issued by the General Accounting Office with an abstract that begins "Intellectual property--which includes federally granted patents, trademarks, and copyrights--is often owned or used by state governmental entities, such as public institutions of higher education. Until recently, state entities that made unauthorized use of, or "infringed," the intellectual property of others were subject to lawsuits in federal court. In 1999, however, the U.S. Supreme Court held that states w… more
Date: September 25, 2001
Creator: United States. General Accounting Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Deposits of Biological Materials in Support of Certain Patent Applications

Description: A letter report issued by the General Accounting Office with an abstract that begins "Under U.S. patent law, a patent must describe the subject invention in enough detail for someone skilled in that field to use or make it. In cases involving biological materials, the inventor may have to submit a sample. Some members of the biotechnology industry believe that biological deposits make patent infringement easier, reasoning that a person or organization can obtain a sample of the deposit and then… more
Date: October 16, 2000
Creator: United States. General Accounting Office.
Partner: UNT Libraries Government Documents Department
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The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology

Description: Congressional interest in facilitating U.S. technological innovation led to the passage of P.L. 96-517, Amendments to the Patent and Trademark Act, commonly referred to as the "Bayh-Dole Act" after its two main sponsors former Senators Robert Dole and Birch Bayh. 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. This report discusses the rationale … more
Date: November 16, 2010
Creator: Schacht, Wendy H.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: U.S. Efforts Have Contributed to Strengthened Laws Overseas, but Challenges Remain

Description: A letter report issued by the Government Accountability Office with an abstract that begins "Although the U.S. government provides broad protection for intellectual property, intellectual property protection in parts of the world is inadequate. As a result, U.S. goods are subject to piracy and counterfeiting in many countries. A number of U.S. agencies are engaged in efforts to improve protection of U.S. intellectual property abroad. This report describes U.S agencies' efforts, the mechanisms u… more
Date: September 8, 2004
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: USPTO Has Made Progress in Hiring Examiners, but Challenges to Retention Remain

Description: A letter report issued by the Government Accountability Office with an abstract that begins "The U.S. Patent and Trademark Office (USPTO) is responsible for issuing U.S. patents that protect new ideas and investments in innovation and creativity. Recent increases in both the complexity and volume of patent applications have increased the time it takes to process patents and have raised concerns about the validity of the patents USPTO issues. Adding to these challenges is the difficulty that USP… more
Date: June 17, 2005
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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Intellectual Property: Enhanced Planning by U.S. Personnel Overseas Could Strengthen Efforts

Description: A letter report issued by the Government Accountability Office with an abstract that begins "Intellectual property (IP) protection and enforcement is inadequate in parts of the world, resulting in significant losses to U.S. industry and increased public health and safety risks. GAO was asked to evaluate U.S. government efforts to enhance protection and enforcement of IP overseas. Using a case study approach, this report (1) describes the key IP protection and enforcement issues at four posts in… more
Date: September 30, 2009
Creator: United States. Government Accountability Office.
Partner: UNT Libraries Government Documents Department
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An Overview of Recent U.S. Supreme Court Jurisprudence in Patent Law

Description: This report provides a brief summary of the Supreme Court's patent law jurisprudence in the following nine cases that have been decided since 2005: Merck KGaA v. Integra Lifesciences I, Unitherm Food Systems v. Swift-Eckrich, Illinois Tool Works v. Independent Ink, eBay v. MercExchange, Laboratory Corporation of America Holdings v. Metabolite Labs., MedImmune v. Genentech, KSR International Co. v. Teleflex Inc., Microsoft v. AT&T, Quanta Computer, Inc. v. LG Electronics, Inc., and Bilski v. Kap… more
Date: September 17, 2010
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
open access

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 suit… more
Date: September 20, 2010
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department
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