Pre-ANDA Litigation

Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition

Buch | Hardcover

1144 Seiten

2022
American Bar Association (Verlag)
978-1-63905-114-4 (ISBN)

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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

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.

Erscheinungsdatum	28.04.2023
Verlagsort	Chicago, IL
Sprache	englisch
Maße	178 x 254 mm
Themenwelt	Recht / Steuern ► EU / Internationales Recht
	Recht / Steuern ► Öffentliches Recht
	Recht / Steuern ► Privatrecht / Bürgerliches Recht ► Zivilverfahrensrecht
	Recht / Steuern ► Wirtschaftsrecht ► Urheberrecht
ISBN-10	1-63905-114-7 / 1639051147
ISBN-13	978-1-63905-114-4 / 9781639051144
Zustand	Neuware