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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.

Book Synopsis ANDA Litigation by : Kenneth L. Dorsney

Download or read book ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Anda Litigation

Author: Kenneth L. Dorsney

Publisher:

Published: 2016

Total Pages: 957

ISBN-13: 9781634254588

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"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."--

Book Synopsis Anda Litigation by : Kenneth L. Dorsney

Download or read book Anda Litigation written by Kenneth L. Dorsney and published by . This book was released on 2016 with total page 957 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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."--

Pre-ANDA Litigation

Author: Kenneth L. Dorsney

Publisher:

Published: 2018

Total Pages: 1007

ISBN-13: 9781641051194

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Book Synopsis Pre-ANDA Litigation by : Kenneth L. Dorsney

Download or read book Pre-ANDA Litigation written by Kenneth L. Dorsney and published by . This book was released on 2018 with total page 1007 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Generic drug entry prior to patent expiration an FTC study

Author:

Publisher: DIANE Publishing

Published: 2002

Total Pages: 129

ISBN-13: 1428951938

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Book Synopsis Generic drug entry prior to patent expiration an FTC study by :

Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Pre-ANDA Litigation

Author: Kenneth L. Dorsney

Publisher:

Published: 2022

Total Pages: 0

ISBN-13: 9781639051144

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"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"--

Book Synopsis Pre-ANDA Litigation by : Kenneth L. Dorsney

Download or read book Pre-ANDA Litigation written by Kenneth L. Dorsney and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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"--

Patent Litigation Strategies Handbook

Author: Barry L. Grossman

Publisher: BNA Books (Bureau of National Affairs)

Published: 2010

Total Pages: 0

ISBN-13: 9781570188862

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"Section of Intellectual Property Law, American Bar Association."

Book Synopsis Patent Litigation Strategies Handbook by : Barry L. Grossman

Download or read book Patent Litigation Strategies Handbook written by Barry L. Grossman and published by BNA Books (Bureau of National Affairs). This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Section of Intellectual Property Law, American Bar Association."

Biotechnology Law

Author: Alan J. Morrison

Publisher: Columbia University Press

Published: 2020-02-04

Total Pages: 466

ISBN-13: 0231550928

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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.

Book Synopsis Biotechnology Law by : Alan J. Morrison

Download or read book Biotechnology Law written by Alan J. Morrison and published by Columbia University Press. This book was released on 2020-02-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook on ERISA Litigation

Author: James F. Jorden

Publisher: Aspen Publishers Online

Published: 2006-12-19

Total Pages: 1151

ISBN-13: 073556311X

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Handbook on ERISA Litigation cuts through complicated statutory provisions andtells you which ERISA claims are recognized by which courts and how tolitigate them.

Book Synopsis Handbook on ERISA Litigation by : James F. Jorden

Download or read book Handbook on ERISA Litigation written by James F. Jorden and published by Aspen Publishers Online. This book was released on 2006-12-19 with total page 1151 pages. Available in PDF, EPUB and Kindle. Book excerpt: Handbook on ERISA Litigation cuts through complicated statutory provisions andtells you which ERISA claims are recognized by which courts and how tolitigate them.

Generic Drug Product Development

Author: Leon Shargel

Publisher: CRC Press

Published: 2013-10-24

Total Pages: 397

ISBN-13: 1420086367

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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

Book Synopsis Generic Drug Product Development by : Leon Shargel

Download or read book Generic Drug Product Development written by Leon Shargel and published by CRC Press. This book was released on 2013-10-24 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Circuit Conflicts in Antitrust Litigation

Author: John H. Bogart

Publisher: American Bar Association

Published: 2009

Total Pages: 104

ISBN-13: 9781604425444

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Book Synopsis Circuit Conflicts in Antitrust Litigation by : John H. Bogart

Download or read book Circuit Conflicts in Antitrust Litigation written by John H. Bogart and published by American Bar Association. This book was released on 2009 with total page 104 pages. Available in PDF, EPUB and Kindle. Book excerpt: