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Author :
Publisher : DIANE Publishing
ISBN 13 : 143798553X
Total Pages : 16 pages
Book Rating : 4.4/5 (379 download)
Download or read book Pay-for-Delay: How Drug Company Pay-Offs Cost Consumers Billions written by and published by DIANE Publishing. This book was released on 2010 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Robin Feldman
Publisher : Cambridge University Press
ISBN 13 : 131673949X
Total Pages : 165 pages
Book Rating : 4.3/5 (167 download)
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.
Author : Herbert HOVENKAMP
Publisher : Harvard University Press
ISBN 13 : 9780674038820
Total Pages : 392 pages
Book Rating : 4.0/5 (388 download)
Download or read book The Antitrust Enterprise written by Herbert HOVENKAMP and published by Harvard University Press. This book was released on 2009-06-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Author : Jay M. Feinman
Publisher : Penguin
ISBN 13 : 1101196289
Total Pages : 241 pages
Book Rating : 4.1/5 (11 download)
Download or read book Delay, Deny, Defend written by Jay M. Feinman and published by Penguin. This book was released on 2010-03-18 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expose of insurance injustice and a plan for consumers and lawmakers to fight it Over the last two decades, insurance has become less of a safety net and more of a spider's web: sticky and complicated, designed to ensnare as much as to aid. Insurance companies now often try to delay payment of justified claims, deny payment altogether, and defend these actions by forcing claimants to enter litigation. Jay M. Feinman, a legal scholar and insurance expert, explains how these trends developed, how the government ought to fix the system, and what the rest of us can do to protect ourselves. He shows that the denial of valid claims is not occasional or accidental or the fault of a few bad employees. It's the result of an increasing and systematic focus on maximizing profits by major companies such as Allstate and State Farm. Citing dozens of stories of victims who were unfairly denied payment, Feinman explains how people can be more cautious when shopping for policies and what to do when pursuing a disputed claim. He also lays out a plan for the legal reforms needed to prevent future abuses. This exposé will help drive the discussion of this increasingly hot- button issue.
Author : Competition P. Subcommittee on Antitrust
Publisher : CreateSpace
ISBN 13 : 9781514385494
Total Pages : 134 pages
Book Rating : 4.3/5 (854 download)
Download or read book Pay-For-Delay Deals written by Competition P. Subcommittee on Antitrust and published by CreateSpace. This book was released on 2015-06-17 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2012, analysts estimate that Americans spent $325 billion on prescription drugs and they predict that drug sales will rise by more than four percent in the year 2014. Generic drugs, which can cost as much as 90 percent lower than brand-name drugs, help rein in the costs. A brand-name drug that costs $300 per month might be sold as a generic for as little as $30 per month, but for several years, pay-for-delay deals have robbed consumers of cost-saving generic drugs. At the very core, these deals involve collusion between brand and generic competitors to keep generic competition off the market. A brand-name drug company pays their generic competitor cash or another form of payment. In exchange, the generic delays its entry into the marketplace. The brand company wins because it gets to maintain its monopoly, and the generic company wins because they get paid more than they would have if they came to market. But American consumers and American taxpayers lose out on lower-cost generic drugs to the tune of billions of dollars each year, $3.5 billion according to the Federal Trade Commission.
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Publisher :
ISBN 13 :
Total Pages : 184 pages
Book Rating : 4.:/5 (327 download)
Download or read book Pay to Delay written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy and published by . This book was released on 2010 with total page 184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Christina M. Curtin
Publisher : Nova Science Publishers
ISBN 13 : 9781611220711
Total Pages : 0 pages
Book Rating : 4.2/5 (27 download)
Download or read book Generic Drugs written by Christina M. Curtin and published by Nova Science Publishers. This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Brand-name pharmaceutical companies can delay generic competition that lowers prices by agreeing to pay a generic competitor to hold its competing product off the market for a certain period of time. These so-called "pay-for-delay" agreements have arisen as part of patent litigation settlement agreements between brand-name and generic pharmaceutical companies. "Pay-for-delay" agreements are "win-win" for the companies: brand name pharmaceutical prices stay high, and the brand and generic share the benefits of the brand's monopoly profits. Consumers lose, however: they miss out on generic prices that can be as much as 90 percent less than brand prices. For example, brand-name medication that costs $300 per month, might be sold as a generic for as little as $30 per month. This book examines the "pay-for-delay' program and how drug company pay-offs cost consumers billions.
Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
ISBN 13 : 9403501146
Total Pages : 520 pages
Book Rating : 4.4/5 (35 download)
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.
Author : Van Bael & Bellis
Publisher : Kluwer Law International B.V.
ISBN 13 : 9041154051
Total Pages : 1618 pages
Book Rating : 4.0/5 (411 download)
Download or read book Competition Law of the European Union written by Van Bael & Bellis and published by Kluwer Law International B.V.. This book was released on 2021-03-01 with total page 1618 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new Sixth Edition of a major work by the well-known competition law team at Van Bael & Bellis in Brussels brings the book up to date to take account of the many developments in the case law and relevant legislation that have occurred since the Fifth Edition in 2010. The authors have also taken the opportunity to write a much-extended chapter on private enforcement and a dedicated section on competition law in the pharmaceutical sector. As one would expect, the new edition continues to meet the challenge for businesses and their counsel, providing a thoroughly practical guide to the application of the EU competition rules. The critical commentary cuts through the theoretical underpinnings of EU competition law to expose its actual impact on business. In this comprehensive new edition, the authors examine such notable developments as the following: important rulings concerning the concept of a restriction by object under Article 101; the extensive case law in the field of cartels, including in relation to cartel facilitation and price signalling; important Article 102 rulings concerning pricing and exclusivity, including the Post Danmark and Intel judgments, as well as standard essential patents; the current block exemption and guidelines applicable to vertical agreements, including those applicable to the motor vehicle sector; developments concerning online distribution, including the Pierre Fabre and Coty rulings; the current guidelines and block exemptions in the field of horizontal cooperation, including the treatment of information exchange; the evolution of EU merger control, including court defeats suffered by the Commission and the case law on procedural infringements; the burgeoning case law related to pharmaceuticals, including concerning reverse payment settlements; the current technology transfer guidelines and block exemption; procedural developments, including in relation to the right to privacy, access to file, parental liability, fining methodology, inability to pay and hybrid settlements; the implementation of the Damages Directive and the first interpretative rulings. As a comprehensive, up-to-date and above all practical analysis of the EU competition rules as developed by the Commission and EU Courts, this authoritative new edition of a classic work stands alone. Like its predecessors, it will be of immeasurable value to both business persons and their legal advisers.
Author : United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Competition Policy, and Consumer Rights
Publisher :
ISBN 13 :
Total Pages : 132 pages
Book Rating : 4.F/5 ( download)
Download or read book Pay-for-delay Deals written by United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Antitrust, Competition Policy, and Consumer Rights and published by . This book was released on 2013 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : American Bar Association. House of Delegates
Publisher : American Bar Association
ISBN 13 : 9781590318737
Total Pages : 216 pages
Book Rating : 4.3/5 (187 download)
Download or read book Model Rules of Professional Conduct written by American Bar Association. House of Delegates and published by American Bar Association. This book was released on 2007 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.
Author :
Publisher : DIANE Publishing
ISBN 13 : 1428951938
Total Pages : 129 pages
Book Rating : 4.4/5 (289 download)
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:
Author : Pablo Figueroa
Publisher : Edward Elgar Publishing
ISBN 13 : 1785362615
Total Pages : 758 pages
Book Rating : 4.7/5 (853 download)
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Author : Laura Karas
Publisher :
ISBN 13 :
Total Pages : 16 pages
Book Rating : 4.:/5 (13 download)
Download or read book Pharmaceutical 'Pay-for-Delay' Reexamined written by Laura Karas and published by . This book was released on 2020 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement that includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or “pay-for-delay.” Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the legality of pay-for-delay deals. In this article, we argue that convoluted settlements in the post-Actavis landscape that camouflage value transfers from brand-name to generic companies necessitate a shift in the focus of antitrust scrutiny to the existence of any restriction on generic entry together with a category of patent less likely to survive a challenge. We conclude with a discussion of pay-for-delay bills in the 116th Congress and propose several reforms to deter pay-for-delay behavior.
Author : Rudolph J.R Peritz
Publisher :
ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)
Download or read book A Brief Introduction to Competition Concerns in 'Pay-for-Delay' Settlement Agreements Between Brand-Name and Generic Drug Companies written by Rudolph J.R Peritz and published by . This book was released on 2013 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antitrust authorities in both the United States and Europe have expressed deep concern over settlements of antitrust cases in the pharmaceutical sector, settlements involving “reverse payments” from plaintiffs to defendants, large sums paid by branded pharmaceutical companies to generic competitors in exchange for promises to stay off the market. Such “pay-for-delay” settlements have proliferated in the United States since federal circuit courts of appeals have found them unproblematic despite the Federal Trade Commission's persistently strong position that they violate the antitrust laws. These cases arise at the intersection of three statutory regimes seeking to promote innovation, three clusters of doctrine and policy that have interacted only to reach impasse: the Patent Act, the 1984 amendment to the Food, Drug, and Cosmetic Act, and finally the Sherman Anti-Trust Act. Antitrust is a late comer to the fierce competition over patented drugs, competition that permeates the approval process in the Food & Drug Administration [the FD , competition that is restrained by these pay-for-delay settlement agreements. To set the stage, we begin with the Patent Act and its relationship to the FDA approval process. The story of pay-for-delay settlements then proceeds to the settlement agreements and their antitrust implications. We conclude that the best solution in these antitrust cases would be adoption of the FTC's approach of presumptive illegality. Together with an amendment proposed to fix the food and drug act, the presumptive illegality of pay-for-delay settlements under the antitrust laws would make the market for pharmaceuticals more price competitive, open weak patents to serious challenge, and as a result save consumers billions of dollars annually without taking from branded drug companies legitimately earned incentives to engage in research and development.
Author : Katherine Eban
Publisher : HarperCollins
ISBN 13 : 0063054108
Total Pages : 512 pages
Book Rating : 4.0/5 (63 download)
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.
Author : J. Thomas Rosch
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (839 download)
Download or read book How Pay-for-delay Settlements Make Consumers and the Federal Government Pay More for Much Needed Drugs written by J. Thomas Rosch and published by . This book was released on 2009 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
