Description: Pre-ANDA Litigation by Kenneth Laurence Dorsney 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 strategyPreclinical and patent considerationsClinical trials and regulatory considerationsTrademark (TM) and nonproprietary name considerationsAcquiring and in-licensing pharmaceutical productsPre-litigation investigations and due diligenceMarket entry business considerations for generic companies FORMAT Hardcover LANGUAGE English CONDITION Brand New Author Biography 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. Kens 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 ABAs ANDA Litigation: Strategies and Tactics for Pharmaceutical Patent Litigators, now in its third edition, AIPLA and Bloomberg Laws Evidence in Patent Cases, and the ABAs Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, first and second editions. Details ISBN1639051147 Short Title Pre-ANDA Litigation Publisher American Bar Association Language English Year 2022 ISBN-10 1639051147 ISBN-13 9781639051144 Format Hardcover Author Kenneth Laurence Dorsney Pages 1144 Publication Date 2022-07-15 Imprint American Bar Association Subtitle Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition Edited by Kenneth Laurence Dorsney Place of Publication Chicago, IL Country of Publication United States AU Release Date 2022-07-15 NZ Release Date 2022-07-15 US Release Date 2022-07-15 UK Release Date 2022-07-15 DEWEY 346.730486 Audience Professional & Vocational We've got this At The Nile, if you're looking for it, we've got it. With fast shipping, low prices, friendly service and well over a million items - you're bound to find what you want, at a price you'll love! TheNile_Item_ID:141850085;
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Format: Hardcover
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Author: Kenneth Laurence Dorsney
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Book Title: Pre-ANDA Litigation