Follow-On Biologics: The Law and Intellectual Property Issues

Follow-On Biologics: The Law and Intellectual Property Issues

Date: January 15, 2014
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: October 31, 2008
Creator: Schacht, Wendy H. & Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
An Overview of the "Patent Trolls" Debate

An Overview of the "Patent Trolls" Debate

Date: April 16, 2013
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents

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

Date: March 7, 2013
Creator: Yeh, Brian T.
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).
Contributing Partner: UNT Libraries Government Documents Department
Deferred Examination of Patent Applications: Implications for Innovation Policy

Deferred Examination of Patent Applications: Implications for Innovation Policy

Date: May 27, 2010
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology

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

Date: November 16, 2010
Creator: Schacht, Wendy H.
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.
Contributing Partner: UNT Libraries Government Documents Department
The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology

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

Date: December 3, 2012
Creator: Schacht, Wendy H.
Description: Report that discusses the rationale behind the passage of P.L. 96-517, its provisions, and implementation of the law.
Contributing Partner: UNT Libraries Government Documents Department
Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Date: May 6, 2005
Creator: Schacht, Wendy H & Thomas, John R
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.
Contributing Partner: UNT Libraries Government Documents Department
Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Bioterrorism Countermeasure Development: Issues in Patents and Homeland Security

Date: January 17, 2006
Creator: Schacht, Wendy H & Thomas, John R
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.
Contributing Partner: UNT Libraries Government Documents Department
False Patent Marking: Litigation and Legislation

False Patent Marking: Litigation and Legislation

Date: September 20, 2010
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
False Patent Marking: Litigation and Legislation

False Patent Marking: Litigation and Legislation

Date: October 20, 2010
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine

Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine

Date: November 6, 2012
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
An Examination of the Issues Surrounding Biotechnology Patenting and Its Effect Upon Entrepreneurial Companies

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

Date: August 31, 2000
Creator: Thomas, John R
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.
Contributing Partner: UNT Libraries Government Documents Department
Patent Reform: Overview and Comparison of S. 507 and H.R. 400

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

Date: August 4, 1998
Creator: Schrader, Dorothy
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Patent Ownership and Federal Research and Development (R and D): A Discussion on the Bayh-Dole Act and the Stevenson-Wydler Act

Patent Ownership and Federal Research and Development (R and D): A Discussion on the Bayh-Dole Act and the Stevenson-Wydler Act

Date: December 11, 2000
Creator: Schacht, Wendy H
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Qui Tam: An Abbreviated Look at the False Claims Act and Related Federal Statutes

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

Date: August 6, 2009
Creator: Doyle, Charles
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.
Contributing Partner: UNT Libraries Government Documents Department
Patent Reform in the 111th Congress: Innovation Issues

Patent Reform in the 111th Congress: Innovation Issues

Date: April 9, 2009
Creator: Schacht, Wendy H. & John R. Thomas
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.
Contributing Partner: UNT Libraries Government Documents Department
An Overview of Recent U.S. Supreme Court Jurisprudence in Patent Law

An Overview of Recent U.S. Supreme Court Jurisprudence in Patent Law

Date: September 17, 2010
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
An Overview of the "Patent Trolls" Debate

An Overview of the "Patent Trolls" Debate

Date: August 20, 2012
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
Patent Reform: Issues in the Biomedical and Software Industries

Patent Reform: Issues in the Biomedical and Software Industries

Date: April 7, 2006
Creator: Schacht, Wendy H
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Influenza Antiviral Drugs and Patent Law Issues

Influenza Antiviral Drugs and Patent Law Issues

Date: November 18, 2005
Creator: Yeh, Brian T.
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.
Contributing Partner: UNT Libraries Government Documents Department
The Bayh-Dole Act: Selected Issues in Patent Policy and the Commercialization of Technology

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

Date: February 3, 2009
Creator: Schacht, Wendy H.
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.
Contributing Partner: UNT Libraries Government Documents Department
Intellectual Property Rights Violations: Federal Civil Remedies and Criminal Penalties Related to Copyrights, Trademarks, and Patents

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

Date: October 31, 2008
Creator: Yeh, Brian T.
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).
Contributing Partner: UNT Libraries Government Documents Department
Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Pharmaceutical Patent Litigation Settlements: Implications for Competition and Innovation

Date: November 4, 2008
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
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