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 ยง 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
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