Pre-Anda Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition

Name: Pre-Anda Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition
Brand: American Bar Association
SKU: 9781639051144
Price: 37932.0 INR
Availability: InStock

by Kenneth Laurence Dorsney

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ISBN13: 9781639051144
Binding: Hardcover
Subject: N/A
Publisher: American Bar Association
Publisher Imprint: American Bar Association
Publication Date: July 15, 2022
Pages: 1144
Original Price: USD 349.0
Language: English
Edition: 3
Item Weight: 1724 grams
BISAC Subject(s): Administrative Law & Regulatory Practice

About The Book

All pharmaceutical companies, whether they are an innovator or a generic, must navigate the same complex legal and regulatory framework to bring a product to market and fend off competition. Now completely updated, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.

From the perspective of an innovator company, patents are vital to protect new drug products both to recoup the initial investment and for future investments. For the innovator and patent owner, the patentee must be aware of the risk to those intellectual property rights and be prepared for any patent challenge. Both entities can use Pre-ANDA Litigation as a resource to help formulate a strategy before patent litigation begins.

ANDA Patent litigations and strategies are complex and require the patent professional to be able to explain complex technical and legal issues to lay persons, both within the organization and to judges and juries. This compendium provides lawyers with invaluable and in-depth tactics and advice so that any pharmaceutical litigant wanting to increase market share, whether as an innovator or a generic, can plan early and be ready to alter plans as new events occur.

Topics include:

Coordinating new drug application (NDA) and patent portfolio strategy
Preclinical and patent considerations
Clinical trials and regulatory considerations
Trademark (TM) and nonproprietary name considerations
Acquiring and in-licensing pharmaceutical products
Pre-litigation investigations and due diligence
Market entry business considerations for generic companies

About The Author

Dorsney, Kenneth Laurence: -

Kenneth L. Dorsney is the Chair of Morris James' Intellectual Property Practice. He is a registered patent attorney with over 20 years of experience resolving patent, trademark, trade secret and copyright disputes in the District of Delaware, through litigation and mediation. Ken's practice focuses on the representation of corporate clients and the interests of outside counsel in a wide variety of complex intellectual property matters. According to IAM Patent 100 magazine "Trial-savvy Kenneth L. Dorsney boasts "excellent credentials"; a registered patent attorney, he has a commanding grasp of the legal and technical issues at play in any dispute."

Ken was appointed by Chief Judge Connolly to serve on the Lawyer Advisory Committee for the U.S.D.C. in Delaware.

Ken has spoken at numerous seminars and law schools on patent law and litigation and is Editor-in-Chief and a Co-Author; the ABA's ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, now in its third edition, AIPLA and Bloomberg Law's Evidence in Patent Cases, and the ABA's Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, first and second editions.

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