Search Results

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.
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

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.
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: March 7, 2013
Creator: Yeh, Brian T.
Item Type: Report
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.
Item Type: Report
Partner: UNT Libraries Government Documents Department

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 behind the passage of P.L. 96-517, its provisions, and implementation of the law.
Date: November 16, 2010
Creator: Schacht, Wendy H.
Item Type: Report
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.
Item Type: Report
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.
Item Type: Report
Partner: UNT Libraries Government Documents Department

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

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. Kappos.
Date: September 17, 2010
Creator: Yeh, Brian T.
Item Type: Report
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.
Item Type: Report
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.
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

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

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

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.
Item Type: Report
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.
Item Type: Report
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.
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: January 20, 2011
Creator: 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, 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.
Item Type: Report
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
Item Type: Report
Partner: UNT Libraries Government Documents Department