Pharmaceutical and Biotech Patent Law
Pharmaceutical and Biotech Patent Law

Author: Arnold & Porter Kaye Scholer Llp

Publisher:

Published: 2019-06-07

Total Pages: 1204

ISBN-13: 9781402431388

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Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Economic Regulation and Its Reform
Economic Regulation and Its Reform

Author: Nancy L. Rose

Publisher: University of Chicago Press

Published: 2014-08-29

Total Pages: 619

ISBN-13: 022613816X

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The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.

Patents for Chemicals, Pharmaceuticals, and Biotechnology
Patents for Chemicals, Pharmaceuticals, and Biotechnology

Author: Philip W. Grubb

Publisher: Oxford University Press, USA

Published: 2016

Total Pages: 0

ISBN-13: 9780199684731

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The nature and origins of patent rights -- Historical developments -- Harmonization of patent law -- What can be patented -- Filing a patent application -- Obtaining a granted patent : patent cooperation treaty procedure -- Obtaining a granted patent : European patent office procedure -- Obtaining a granted patent : national procedures -- Maintaining a patent in force and extending the patent term -- Enforcing patent rights -- Invalidity and amendment of granted patents -- Chemical inventions -- Pharmaceutical inventions -- Biotechnological inventions -- Patenting of genes, plants, and animals -- The patent practitioner and his function -- Drafting the patent specification -- Drafting the claims -- Prosecution of the patent application to grant -- Inventorship, ownership, and compensation -- Commercial exploitation of patents -- How to catch the infringer and how not to be caught -- Patent aspects of licensing -- Patents and competition law : United Kingdom and European Union -- Patents and competition law : United States

Drafting Agreements in the Biotechnology and Pharmaceutical Industries
Drafting Agreements in the Biotechnology and Pharmaceutical Industries

Author: Mark Anderson

Publisher: OUP Oxford

Published: 2009-04-02

Total Pages: 0

ISBN-13: 9780199539635

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Provides precedent agreements in relation to the main types of commercial transaction encountered in biotechnology and pharmaceutical industries. Each agreement is accompanied by detailed commentary on legal, commercial and practice issues incorporating commentary highlighting key differences between English law and other key EU jurisdictions

Pharmaceutical Innovation, Competition and Patent Law
Pharmaceutical Innovation, Competition and Patent Law

Author: Josef Drexl

Publisher: Edward Elgar Publishing

Published: 2013-01-01

Total Pages: 347

ISBN-13: 0857932462

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Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author: Stephen M. Kanovsky

Publisher:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

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FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.

Biotechnology and the Patent System
Biotechnology and the Patent System

Author: Claude E. Barfield

Publisher: A E I Press

Published: 2007

Total Pages: 116

ISBN-13: 9780844742564

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American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.

The Business of Healthcare Innovation
The Business of Healthcare Innovation

Author: Lawton Robert Burns

Publisher: Cambridge University Press

Published: 2005-08-25

Total Pages: 408

ISBN-13: 9781139445887

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The Business of Healthcare Innovation is the first wide-ranging analysis of business trends in the manufacturing segment of the health care industry. In this leading edge volume, Professor Burns focuses on the key role of the 'producers' as the main source of innovation in health systems. Written by professors of the Wharton School and industry executives, this book provides a detailed overview of the pharmaceutical, biotechnology, genomics/proteomics, medical device and information technology sectors. It analyses the market structures of these sectors as well as the business models and corporate strategies of firms operating within them. Most importantly, the book describes the growing convergence between these sectors and the need for executives in one sector to increasingly draw upon trends in the others. It will be essential reading for students and researchers in the field of health management, and of great interest to strategy scholars, industry practitioners and management consultants.