[PDF] The False Promise Of Breaking Patents To Lower Drug Prices eBook

Author : Adam Mossoff
Publisher :
Page : 0 pages
File Size : 47,24 MB
Release : 2023
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The patent system is at the center of heated policy debates about drug prices, as some scholars and policy organizations claim that patents are a principal cause of rising drug prices. They propose price controls be imposed on drug patents to lower drug prices, and they claim federal agencies are authorized to do so by two federal statutes: § 1498 and the march-in power in § 203 of the Bayh-Dole Act. These price-control theories of § 1498 and the Bayh-Dole Act allege that Congress has already authorized federal agencies to break patents by imposing price controls on sales of patented products in the marketplace. This Article explains that these statutes do not authorize agencies to impose price controls on drug patents, as evidenced by their plain text and by longstanding judicial and agency interpretations of these two statutes. The price-control theories of § 1498 and the Bayh-Dole Act contradict the text and function of both statutes. Section 1498 is an eminent domain statute, applying only when a patent is “used by and for the United States.” This is not the case of a private company authorized by the government to sell a patented drug at a lower price than the drug innovator who owns the patent. Section 203 in the Bayh-Dole Act specifies only four delimited conditions when an agency may “march in” and license a patent without authorization by a patent owner. All address circumstances when a product is not available at all in the marketplace; price is not a specified condition. In sum, neither § 1498 nor the Bayh-Dole Act authorize a federal agency to impose price controls in private transactions in the marketplace between companies and consumers. There is a significant body of scholarship and policy work-product advancing the price-control theories of § 1498 and the Bayh-Dole Act, but these are policy arguments masquerading as statutory construction. It is time to lay these statutory myths to rest and to have a forthright policy debate.

Author : Institute of Medicine
Publisher : National Academies Press
Page : 377 pages
File Size : 18,39 MB
Release : 2013-06-20
Category : Medical
ISBN : 0309269393

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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Author : Christopher Scott Hemphill
Publisher : Stanford University
Page : 249 pages
File Size : 36,4 MB
Release : 2010
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This dissertation examines the law and economics of generic drug entry, and the problems that arise from specific U.S. regulatory arrangements that govern innovation and competition in the market for patented pharmaceuticals. As Chapter 1 explains, competitive entry by generic drug makers is limited by both patents and industry-specific regulation, which together provide the means for brand-name drug makers to avoid competition and thereby recoup large investments in research, development, and testing. At the same time, the complex rules of the Hatch-Waxman Act furnish a pathway by which generic drug makers may challenge the validity or scope of brand-name patents, with a view to entering the market with a competing product prior to patent expiration. The subsequent chapters examine several aspects of the competitive interaction between brand-name and generic drug makers. Chapter 2 analyzes settlements of patent litigation between brand-name and generic drug makers, in which the brand-name firm pays the generic firm in exchange for delayed market entry. Such pay-for-delay settlements are an important, unresolved question in U.S. antitrust policy. The analysis reveals that the pay-for-delay settlement problem is more severe than has been commonly understood. Several specific features of the Act—in particular, a 180-day bounty granted to certain generic drug makers as an incentive to pursue pre-expiration entry—widen the potential for anticompetitive harm from pay-for-delay settlements, compared to the usual understanding. In addition, I show that settlements are "innovation inefficient" as a means of providing profits and hence ex ante innovation incentives to brand-name drug makers. To the extent that Congress established a preferred tradeoff between innovation and competition when it passed the Act, settlements that implement a different, less competition-protective tradeoff are particularly problematic from an antitrust standpoint. Chapter 3 synthesizes available public information about pay-for-delay settlements in order to offer a new account of the extent and evolution of settlement practice. The analysis draws upon a novel dataset of 143 such settlements. The analysis uncovers an evolution in the means by which a brand-name firm can pay a generic firm to delay entry, including a variety of complex "side deals" by which a brand-name firm can compensate a generic firm in a disguised fashion. It also reveals several novel forms of regulatory avoidance. The analysis in the chapter suggests that, as a matter of institutional choice, an expert agency is in a relatively good position to conduct the aggregate analysis needed to identify an optimal antitrust rule. Chapter 4 examines the co-evolution of increased brand-name patenting and increased generic pre-expiration challenges. It draws upon a second novel dataset of drug approvals, applications, patents, and other drug characteristics. Its first contribution is to chart the growth of patent portfolios and pre-expiration challenges. Over time, patenting has increased, measured by the number of patents per drug and the length of the nominal patent term. During the same period, challenges have increased as well, and drugs are challenged sooner, relative to brand-name approval. The analysis shows that brand-name sales, a proxy for the profitability of the drug, have a positive effect on the likelihood of generic challenge, consistent with the view that patents that later prove to be valuable receive greater ex post scrutiny. The likelihood of challenge also varies by patent type and timing of expiration. Conditional on sales and other drug characteristics, drugs with weaker patents, particularly those that expire later than a drug's basic compound patent, face a significantly higher likelihood of challenge. Though the welfare implications of Hatch-Waxman patent challenge provisions are complicated, these results suggest these challenges serve a useful purpose, in promoting scrutiny of low quality and late-expiring patents.

Author : Robin Feldman
Publisher : Cambridge University Press
Page : 165 pages
File Size : 14,71 MB
Release : 2017-06-09
Category : Law
ISBN : 131673949X

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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 : Institute of Medicine
Publisher : National Academies Press
Page : 241 pages
File Size : 25,25 MB
Release : 1990-02-01
Category : Medical
ISBN : 0309042860

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The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.

Author : Vannevar Bush
Publisher : Princeton University Press
Page : 186 pages
File Size : 40,24 MB
Release : 2021-02-02
Category : Science
ISBN : 069120165X

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The classic case for why government must support science—with a new essay by physicist and former congressman Rush Holt on what democracy needs from science today Science, the Endless Frontier is recognized as the landmark argument for the essential role of science in society and government’s responsibility to support scientific endeavors. First issued when Vannevar Bush was the director of the US Office of Scientific Research and Development during the Second World War, this classic remains vital in making the case that scientific progress is necessary to a nation’s health, security, and prosperity. Bush’s vision set the course for US science policy for more than half a century, building the world’s most productive scientific enterprise. Today, amid a changing funding landscape and challenges to science’s very credibility, Science, the Endless Frontier resonates as a powerful reminder that scientific progress and public well-being alike depend on the successful symbiosis between science and government. This timely new edition presents this iconic text alongside a new companion essay from scientist and former congressman Rush Holt, who offers a brief introduction and consideration of what society needs most from science now. Reflecting on the report’s legacy and relevance along with its limitations, Holt contends that the public’s ability to cope with today’s issues—such as public health, the changing climate and environment, and challenging technologies in modern society—requires a more capacious understanding of what science can contribute. Holt considers how scientists should think of their obligation to society and what the public should demand from science, and he calls for a renewed understanding of science’s value for democracy and society at large. A touchstone for concerned citizens, scientists, and policymakers, Science, the Endless Frontier endures as a passionate articulation of the power and potential of science.

Author : Lawton R. Burns
Publisher : Cambridge University Press
Page : 400 pages
File Size : 40,8 MB
Release : 2005-08-25
Category : Business & Economics
ISBN : 9780521838986

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The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.

Author : Fritz Machlup
Publisher :
Page : 100 pages
File Size : 45,3 MB
Release : 1958
Category : Patents
ISBN :

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At head of title: 85th Cong., 2d sess. Committee print. Bibliography: p. 81-86.

Author :
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Page : 64 pages
File Size : 36,57 MB
Release : 1955-04
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The Bulletin of the Atomic Scientists is the premier public resource on scientific and technological developments that impact global security. Founded by Manhattan Project Scientists, the Bulletin's iconic "Doomsday Clock" stimulates solutions for a safer world.