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.

Pre-ANDA Litigation
Pre-ANDA Litigation

Author: Kenneth L. Dorsney

Publisher: American Bar Association

Published: 2014

Total Pages: 0

ISBN-13: 9781627227315

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This book is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.

Drug Wars
Drug Wars

Author: Robin Feldman

Publisher: Cambridge University Press

Published: 2017-06-09

Total Pages: 165

ISBN-13: 131673949X

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While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.

IP Strategies for Medical Device Technologies
IP Strategies for Medical Device Technologies

Author: James Love

Publisher:

Published: 2020-04-07

Total Pages: 268

ISBN-13: 9781641052696

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Medical device professionals encounter numerous challenges from successfully developing a medical device company to understanding and navigating the various intellectual property issues that arise as they seek to protect and commercialize their inventions. This is an essential resource for understanding the nuances of protecting and launching a medical device in the United States and abroad. Written by IP and patent attorneys with experience representing the unique business needs of startups, entrepreneurs, and early-stage companies, this guide covers creating and leveraging patent portfolios; freedom to operate; limiting risk of infringement; trademarks in the context of medical devices; strategies for licensing and monetizing patents; and more.