ANDA Litigation
ANDA Litigation

Author: Kenneth L. Dorsney

Publisher: American Bar Association

Published: 2012

Total Pages: 0

ISBN-13: 9781614384786

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Examining the intersection between the statutory and regulatory scheme governing approval of generic pharmaceuticals and U.S. patent law in the context of Paragraph IV ANDA litigation, this comprehensive guide focuses on current and developing law as well as litigation strategies and tactics. This ready roadmap begins with an explanation of the Hatch-Waxman Act, its implementation, and litigation. Other topics include preparing and trying the case, post-trial issues and appeals, remedies, settlement, antitrust implications, and litigation of pharmaceuticals outside the U.S.

Legal Design
Legal Design

Author: Corrales Compagnucci, Marcelo

Publisher: Edward Elgar Publishing

Published: 2021-10-21

Total Pages: 264

ISBN-13: 183910726X

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This innovative book proposes new theories on how the legal system can be made more comprehensible, usable and empowering for people through the use of design principles. Utilising key case studies and providing real-world examples of legal innovation, the book moves beyond discussion to action. It offers a rich set of examples, demonstrating how various design methods, including information, service, product and policy design, can be leveraged within research and practice.

Biochemical Modulation of Skin Reactions
Biochemical Modulation of Skin Reactions

Author: Agis F. Kydonieus

Publisher: CRC Press

Published: 1999-12-15

Total Pages: 352

ISBN-13: 9780849321177

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Like almost every major scientific or medical breakthrough in history, the transdermal delivery of drugs started as only an idea - slowly moving its way from the drawing board to actual testing and eventually approval. Today, there are more than 20 companies involved in transdermal drug delivery. In addition, almost every large pharmaceutical firm has ongoing transdermal delivery programs. But in spite of this effort and after 15 years from the introduction of the Nitroglycerin patch, only six transdermal drugs exist in the marketplace. The practice has been hampered by the fact that most drugs, as well as many excipients used in the manufacture of transdermal patches, cause skin irritation or skin sensitization. Similar problems exist with the application of dermatologicals and cosmetics to skin, which in many cases are equally as severe as those encountered in transdermal delivery. Biochemical Modulation of Skin Reactions: Transdermals, Topicals, Cosmetics presents a series of chapters describing technologies and the practical application of biochemicals which might lead to the reduction or abrogation of these skin reaction. In addition, it addresses those areas of skin immunology and skin sciences that account for the processes that control irritant and allergic contact dermatitis and outlines the numerous cellular and molecular factors involved in the development of irritation and sensitization. Indeed, Biochemical Modulation of Skin Reactions helps serve as a catalyst for further research in the field, allowing for more drugs and cosmetics to be applied to the skin without adverse effects. Features

Strengthening Forensic Science in the United States
Strengthening Forensic Science in the United States

Author: National Research Council

Publisher: National Academies Press

Published: 2009-07-29

Total Pages: 348

ISBN-13: 0309142393

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Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.

Patents in the Knowledge-Based Economy
Patents in the Knowledge-Based Economy

Author: National Research Council

Publisher: National Academies Press

Published: 2003-08-11

Total Pages: 352

ISBN-13: 0309167183

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This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.