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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: Kenneth L. Dorsney
Publisher:
ISBN: 9781634254588
Category : Biotechnology
Languages : en
Pages : 957
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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, this in-depth resource balances perspectives from both name-brand drug patentees and generic drug manufacturers. With a focus on current and developing law as well as practical strategies and tactics for litigation, it covers all steps in the litigation process."--
Author: Kenneth L. Dorsney
Publisher:
ISBN: 9781641051194
Category : Biotechnology
Languages : en
Pages : 1007
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Book Description
Author: Kenneth L. Dorsney
Publisher:
ISBN: 9781639051144
Category : Biotechnology
Languages : en
Pages : 0
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Book Description
"This book, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that the pharmaceutical litigants could follow"--
Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129
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Book Description
Author: Alan J. Morrison
Publisher: Columbia University Press
ISBN: 0231550928
Category : Science
Languages : en
Pages : 466
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Book Description
Biotechnology and law are inextricable. Patent, regulatory, and contract law profoundly shape the biotech industry, and each of these practice areas is deeply intertwined with the science it governs. Yet many in this industry lack even a basic grasp of these laws, jeopardizing their business success as a result. This book is an essential introduction to biotechnology law for scientists, startup founders, regulatory specialists, patent liaisons, investors, academics, students, and other nonattorneys with biotech backgrounds. It covers core topics such as patentability, patent prosecution and infringement, patent opinions, the development and FDA approval of small-molecule and biologic drugs, regulatory exclusivity, generic drugs and ANDA litigation, biosimilars and the patent dance, patent licenses, and collaboration agreements. Written with scientists in mind, Biotechnology Law is a clear, concise, and entirely practical primer on the topic, replete with straightforward, real-world examples to illustrate each key concept. Understanding the legal machinery through which science becomes business is not a luxury—it is a crucial part of a scientist’s training. Alan J. Morrison’s expert treatment embraces this new reality.
Author: Barry L. Grossman
Publisher: BNA Books (Bureau of National Affairs)
ISBN: 9781570188862
Category : Patent laws and legislation
Languages : en
Pages : 0
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Book Description
"Section of Intellectual Property Law, American Bar Association."
Author: James F. Jorden
Publisher: Aspen Publishers Online
ISBN: 073556311X
Category : Business & Economics
Languages : en
Pages : 1151
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Book Description
Handbook on ERISA Litigation cuts through complicated statutory provisions andtells you which ERISA claims are recognized by which courts and how tolitigate them.
Author: Leon Shargel
Publisher: CRC Press
ISBN: 1420086367
Category : Medical
Languages : en
Pages : 397
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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: John H. Bogart
Publisher: American Bar Association
ISBN: 9781604425444
Category : Law
Languages : en
Pages : 104
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Book Description
