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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: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
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: April 16, 2013
Creator: Yeh, Brian T.
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: March 7, 2013
Creator: Yeh, Brian T.
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.
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

Deferred Examination of Patent Applications: Implications for Innovation Policy

Description: This report provides an overview of deferred patent examination. It begins by offering a brief review of patent acquisition proceedings as well as challenges faced by the U.S. Patent and Trademark Office (USPTO). The report then introduces the concept of deferred examination. The potential positive and negative consequences of deferred examination upon the environment for innovation within the United States are then explored. The report closes by identifying salient design parameters for deferred examination systems and reviewing congressional options.
Date: May 27, 2010
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

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

Description: This report provides background information and issues for Congress on multiyear procurement (MYP) and block buy contracting (BBC), which are special contracting mechanisms that Congress permits the Department of Defense (DOD) to use for a limited number of defense acquisition programs.
Date: May 27, 2016
Creator: Yeh, Brian T.
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

Availability of Injunctive Relief for Standard-Essential Patent Holders

Description: This report provides an overview of the current debate over whether a holder of a patent essential to an industry standard, who has promised to license such patented technology on fair, reasonable, and non-discriminatory (FRAND) terms, may nevertheless obtain an injunction from a federal court or an exclusion order from the International Trade Commission against infringing products that implement the industry standard. The report first summarizes several fundamental principles of patent law, then discusses the relationship between standard-setting organizations and FRAND licensing.
Date: January 10, 2013
Creator: Yeh, Brian T.
Partner: UNT Libraries Government Documents Department

Patent Reform: Judicial Developments in Areas of Legislative Interest

Description: This report reviews the relationship between Congress and the courts in patent reform. It begins by offering a summary of the patent system. The report then discusses a number of topics that have been the subject of both judicial and legislative consideration. The current state of the law is then contrasted with legislative reform proposals before previous Congresses. The report closes with observations concerning the subtle interaction between legislative, administrative, and judicial actors within the patent system and their impact upon the U.S. innovation environment.
Date: January 5, 2011
Creator: Thomas, John R.
Partner: UNT Libraries Government Documents Department

Influenza Antiviral Drugs and Patent Law Issues

Description: This report identifies and analyzes the patent law aspects of the current avian influenza drug situation. First, the report explains the role that patent rights have played in affecting the availability of Tamiflu. Second, the report examines options for increasing the drug’s production, including the possibility of governments abrogating Roche’s patent rights by issuing compulsory licenses to other drug companies to manufacture generic versions of Tamiflu without Roche’s consent.
Date: November 18, 2005
Creator: Yeh, Brian T.
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

Patent Reform: Overview and Comparison of S. 507 and H.R. 400

Description: H.R. 400 and S. 507 are similar but different omnibus patent reform proposals. Both bills generally transform the Patent and Trademark Office into a government corporation; require publication of patent applications 18 months after filing, subject to certain exceptions that differ in these bills; and extend the patent term for certain delays in patent issuance. S. 507 also contains provisions on patent reexamination reform. This report summarizes and compares the bills and reviews arguments for and against the proposals.
Date: April 16, 1998
Creator: Dorothy Schrader
Partner: UNT Libraries Government Documents Department

American Inventors Protection Act of 1999

Description: After several years of consideration, on Friday, November 19, 1999, Congress gave final approval to a bill which makes major changes to the patent laws. On this day the Senate passed the American Inventors Protection Act of 1999 as part of the Intellectual Property and Communications Omnibus Reform Act of 1999, attached by reference to the Consolidated Appropriations Act for Fiscal Year 2000. This report summarizes major provisions of the patent reform bill.
Date: February 28, 2000
Creator: Seitzinger, Michael V.
Partner: UNT Libraries Government Documents Department

Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Description: In the 109th Congress, several bills have been introduced, including S. 3, the Protecting America in the War on Terror Act, and S. 975, the Project Bioshield II 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. This report includes patents and innovation, the role of patents in pharmaceutical/biomedical R&D, legislative developments and proposals for change.
Date: May 6, 2005
Creator: Schacht, Wendy H. & Thomas, John R.
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.
Partner: UNT Libraries Government Documents Department

An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies

Description: The biotechnology industry is notable both for its heavy concentration of small businesses and its weighty research and development (R&D) expenditures. Given the small size and heavy expenses of many biotechnology firms, their ability to raise venture capital may be of some consequence. The patent law has been identified as a facilitator of these R&D financing efforts. Congress may choose to exercise oversight on these issues. Such consideration would likely include examination of U.S. commitments in international agreements along with other factors.
Date: August 31, 2000
Creator: Thomas, John R
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
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.
Partner: UNT Libraries Government Documents Department

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