The Leahy-Smith America Invents Act: Innovation Issues

The Leahy-Smith America Invents Act: Innovation Issues

Date: January 15, 2014
Creator: Thomas, John R.
Description: This report provides an overview of the the Leahy-Smith America Invents Act (AIA). It begins by offering a brief overview of the patent system, then identifies and reviews the specific components of this legislation in greater detail. The report closes with further considerations.
Contributing Partner: UNT Libraries Government Documents Department
The Role of Trade Secrets in Innovation Policy

The Role of Trade Secrets in Innovation Policy

Date: January 15, 2014
Creator: Thomas, John R.
Description: This report provides an overview of the law and policy of trade secrets. It discusses the role of trade secrets in six sections: Trade Secrets and Innovation Policy, An Overview of Trade Secret Law (Basic Principles, and Sources of Law), The Economic Espionage Act, Trade Secrets and Patents (Introduction to the Patent System, Trade Secrets and Patents Compared, and The Prior Commercial User Defense), Congressional Issues and Options, and Concluding Observations.
Contributing Partner: UNT Libraries Government Documents Department
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
The Role of Trade Secrets in Innovation Policy

The Role of Trade Secrets in Innovation Policy

Date: August 31, 2010
Creator: Thomas, John R.
Description: This report provides an overview of the law and policy of trade secrets. It discusses the role of trade secrets in U.S. innovation policy. It then reviews the sources of trade secret law and the substantive rules that they provide. The report then provides a more detailed review of existing federal legislation that pertains to trade secrets. In its next section, the report then discusses the relationship between patent law and trade secret law. The report closes with an identification of congressional issues and options within this field.
Contributing Partner: UNT Libraries Government Documents Department
Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Date: July 1, 2008
Creator: Thomas, John R.
Description: This report identifies several current issues relating to intellectual property in industrial designs. It begins by describing the different sorts of intellectual property protection that apply to industrial designs. The report then identifies current issues at the interface between intellectual property and industrial designs. The report closes by reviewing the impact that sui generis rights regimes may have upon innovation and competition in the United States.
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
Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Intellectual Property in Industrial Designs: Issues in Innovation and Competition

Date: January 5, 2011
Creator: Thomas, John R.
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.
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
Intellectual Property and the Free Trade Agreements: Innovation Policy Issues

Intellectual Property and the Free Trade Agreements: Innovation Policy Issues

Date: December 21, 2005
Creator: Thomas, John R
Description: This report discusses Free Trade Agreements (FTA) with Australia, Chile, Singapore, and other trading partners in respect to copyrights, data protection, patents, trademarks, and other forms of intellectual property.
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
Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping

Pharmaceutical Patent-Antitrust: Reverse Payment Settlements and Product Hopping

Date: October 7, 2015
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
Innovation and Intellectual Property Issues in Homeland Security

Innovation and Intellectual Property Issues in Homeland Security

Date: January 17, 2008
Creator: Thomas, John R.
Description: This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Contributing Partner: UNT Libraries Government Documents Department
Patents and Drug Importation

Patents and Drug Importation

Date: June 1, 2007
Creator: Thomas, John R.
Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Contributing Partner: UNT Libraries Government Documents Department
Patent Reform: Judicial Developments in Areas of Legislative Interest

Patent Reform: Judicial Developments in Areas of Legislative Interest

Date: January 5, 2011
Creator: Thomas, John R.
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.
Contributing Partner: UNT Libraries Government Documents Department
Plants, Patents, and Seed Innovation in the Agricultural Industry

Plants, Patents, and Seed Innovation in the Agricultural Industry

Date: September 13, 2002
Creator: Thomas, John R.
Description: This report offers an overview of the availability of intellectual property rights for plants, focusing upon the seed industry. It initially offers an introduction to seed innovation. The report then reviews the three intellectual property regimes applicable to plant innovation: utility patents, plant patents and plant variety protection certificates. It then details a 2001 decision of the U.S. Supreme Court, J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., which held that sexually reproducing plants may be subject to utility patents.
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: January 20, 2011
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
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
Authorized Generic Pharmaceuticals: Effects on Innovation

Authorized Generic Pharmaceuticals: Effects on Innovation

Date: August 8, 2006
Creator: Thomas, John R
Description: The practice of “authorized generics” has recently been the subject of considerable attention by the pharmaceutical industry, regulators, and members of Congress alike. An “authorized generic”–sometimes termed a “branded,” “flanking,” or “pseudo” generic–is a pharmaceutical that is marketed by or on behalf of a brand name drug company, but is sold under a generic name. Although the availability of an additional competitor in the generic drug market would appear to be favorable to consumers, authorized generics have nonetheless proven controversial. Some observers believe that authorized generics potentially discourage independent generic firms both from challenging drug patents and from selling their own products.
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
Scientific Research and the Experimental Use Privilege in Patent Law

Scientific Research and the Experimental Use Privilege in Patent Law

Date: October 28, 2004
Creator: Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Follow-On Biologics: Intellectual Property and Innovation Issues

Follow-On Biologics: Intellectual Property and Innovation Issues

Date: August 3, 2009
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
Intellectual Property, Computer Software and the Open Source Movement

Intellectual Property, Computer Software and the Open Source Movement

Date: March 11, 2004
Creator: Thomas, John R
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Innovation and Intellectual Property Issues in Homeland Security

Innovation and Intellectual Property Issues in Homeland Security

Date: January 17, 2007
Creator: Thomas, John R.
Description: This report examines concerns that patents, trade secrets or other intellectual rights may impede the prompt, widespread and cost-effective distribution of innovations that promote homeland security.
Contributing Partner: UNT Libraries Government Documents Department
Patents and Drug Importation

Patents and Drug Importation

Date: May 25, 2004
Creator: Thomas, John R.
Description: This report explores the intellectual property laws and policies concerning the parallel importation of patented pharmaceuticals into the United States.
Contributing Partner: UNT Libraries Government Documents Department
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