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Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
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Book Description
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.
Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781614384786
Category : Biotechnology
Languages : en
Pages : 0
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Book Description
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.
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author: Kenneth L. Dorsney
Publisher: American Bar Association
ISBN: 9781627227315
Category : Biotechnology
Languages : en
Pages : 0
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Book Description
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.
Author: Barry L. Grossman
Publisher:
ISBN: 9781570187445
Category : Patent laws and legislation
Languages : en
Pages : 0
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Book Description
Author: American College of Trial Lawyers. Complex Litigation Committee
Publisher:
ISBN:
Category : Patent laws and legislation
Languages : en
Pages : 0
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Book Description
Author:
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 1136
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Book Description
Author: John H. Bogart
Publisher: American Bar Association
ISBN: 9781604425444
Category : Law
Languages : en
Pages : 104
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Book Description
Author: Robin Feldman
Publisher: Cambridge University Press
ISBN: 131673949X
Category : Law
Languages : en
Pages : 165
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Book Description
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.
Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Category : Medical
Languages : en
Pages : 384
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Book Description
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
Author: Shashank Upadhye
Publisher:
ISBN: 9780314991447
Category : Generic drugs
Languages : en
Pages : 643
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Book Description
