Download or read book Generic Animal Drug and Patent Term Restoration Act written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice and published by . This book was released on 1989 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Pharmaceutical Innovation Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book ANDA Litigation written by Kenneth L. Dorsney and published by American Bar Association. This book was released on 2012 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Patent Term Restoration Act of 1983 written by United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Patents, Copyrights, and Trademarks and published by . This book was released on 1984 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Download or read book The Patent Term Restoration Act of 1981 S 255 written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 1981 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Term Restoration Act of 1981 written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice and published by . This book was released on 1982 with total page 730 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Patent System for the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2004-10-01 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.
Download or read book Drug Price Competition and Patent Term Restoration Act of 1984 written by United States. Congress. Senate. Committee on Labor and Human Resources and published by . This book was released on 1984 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Agricultural Patent Term Restoration written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice and published by . This book was released on 1986 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book American Inventors Protection Act of 1999 written by United States. Congress. House. Committee on the Judiciary and published by . This book was released on 1999 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Patent Remedies and Complex Products written by C. Bradford Biddle and published by Cambridge University Press. This book was released on 2019-06-27 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: Through a collaboration among twenty legal scholars from North America, Europe and Asia, this book presents an international consensus on the use of patent remedies for complex products such as smartphones, computer networks, and the Internet of Things. This title is also available as Open Access on Cambridge Core.
Download or read book The Waxman Report written by Henry Waxman and published by Twelve. This book was released on 2009-07-02 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: At a time when some of the most sweeping national initiatives in decades are being debated, Congressman Henry Waxman offers a fascinating inside account of how Congress really works by describing the subtleties and complexities of the legislative process. For four decades, Waxman has taken visionary and principled positions on crucial issues and been a driving force for change. Because of legislation he helped champion, our air is cleaner, our food is safer, and our medical care better. Thanks to his work as a top watchdog in Congress, crucial steps have been taken to curb abuses on Wall Street, to halt wasteful spending in Iraq, and to ban steroids from Major League Baseball. Few legislators can match his accomplishments or his insights on how good work gets done in Washington. In this book, Waxman affords readers a rare glimpse into how this is achieved-the strategy, the maneuvering, the behind-the-scenes deals. He shows how the things we take for granted (clear information about tobacco's harmfulness, accurate nutritional labeling, important drugs that have saved countless lives) started out humbly-derided by big business interests as impossible or even destructive. Sometimes, the most dramatic breakthroughs occur through small twists of fate or the most narrow voting margin. Waxman's stories are surprising because they illustrate that while government's progress may seem glacial, much is happening, and small battles waged over years can yield great results. At a moment when so much has been written about what's wrong with Congress-the grid, the partisanship, the influence of interest groups-Henry Waxman offers sophisticated, concrete examples of how government can (and should) work.
Download or read book The ParagraphFour Book written by Gregory Glass and published by . This book was released on 2021-03-23 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The ParagraphFour Book describes how generic drug products make it to a drug store's shelf. In most cases, these products travel through the Paragraph IV Market --- a place where they challenge the validity of the brand drug's patents in a United States District Court. The book covers the Hatch-Waxman Act and the intersection of the patent law, regulations, and competition that create the Paragraph IV Market. Written as an easy-to-read business book, it is not a legal treatise and would appeal to attorneys, pharmaceutical professionals, and interested consumers.
