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Author: Kenneth L. Dorsney Publisher: American Bar Association ISBN: 9781614384786 Category : Biotechnology Languages : en Pages : 0
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
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: 9781627227315 Category : Biotechnology Languages : en Pages : 0
Book Description
This book is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.
Author: Barry L. Grossman Publisher: BNA Books (Bureau of National Affairs) ISBN: 9781570188862 Category : Patent laws and legislation Languages : en Pages : 0
Book Description
"Section of Intellectual Property Law, American Bar Association."
Author: Robin Feldman Publisher: Cambridge University Press ISBN: 131673949X Category : Law Languages : en Pages : 165
Book Description
While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Author: Kung-Chung Liu Publisher: Bloomsbury Publishing ISBN: 1509922792 Category : Law Languages : en Pages : 372
Book Description
The first part of this open access book sets out to re-examine some basic principles of trade negotiation, such as choosing the right representatives to negotiate and enhancing transparency as a cure to the public's distrust against trade talks. Moreover, it analyses how the Comprehensive and Progressive Agreement for the Trans-Pacific Partnership (CPTPP) might impact on the Regional Comprehensive Economic Partnership's (RCEP) IP chapter and examines the possible norm setters of Asian IP. It then focuses on the People's Republic of China's (PRC) trade and IP strategy against the backdrop of the power games between the PRC, India and the US. The second part of the book reflects on issues related to investor–state dispute settlement and its relationship with IP, such as how to re-calibrate the balance in international investment arbitration, and whether compulsory license of IP constitutes expropriation in India, the PRC and select ASEAN countries. The third part of the book questions and strives to improve some of the proposed IP provisions of CPTPP and RCEP and to redefine some aspects of international IP norms, such as: pre-grant patent opposition and experimental use exception; patent term extension; patent linkage and data exclusivity for the pharmaceutical sector; plant variety protection; pre-established damages for copyright infringement; and the restructuring of copyright limitations in the public interest. The open access edition of this book is available under a CC BY-NC-ND 3.0 licence on www.bloomsburycollections.com. Open access was funded by the Applied Research Centre for Intellectual Assets and the Law in Asia, School of Law, Singapore Management University.
Author: Kenneth L. Dorsney
Author: Kenneth L. Dorsney
Author: 
Author: Kenneth L. Dorsney
Author: 
Author: Barry L. Grossman
Author: John H. Bogart
Author: Robin Feldman
Author: Shashank Upadhye
Author: 
Author: Kung-Chung Liu