H.R. 1706, the Protecting Consumer Access to Generic Drugs Act of 2009 PDF Download

Author: United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 328

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Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category : Energy policy
Languages : en
Pages : 264

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Author: American Bar Association Editors
Publisher: American Bar Association
ISBN: 9781604428865
Category : Law
Languages : en
Pages : 462

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Book Description
For over 37 years, Antitrust Law Developments and its annual supplements have been recognized as the single most authoritative and comprehensive set of research tools for antitrust practitioners. The 2009 Annual Review of Antitrust Law Developments summarizes developments during 2009 in the courts, at the agencies, and in Congress.

Author: United States. Congress. House. Committee on Energy and Commerce
Publisher:
ISBN:
Category :
Languages : en
Pages : 1192

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Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
ISBN: 9403501146
Category : Law
Languages : en
Pages : 349

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Book Description
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: United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts and Competition Policy
Publisher:
ISBN:
Category : Business & Economics
Languages : en
Pages : 184

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Author: United States. Congress
Publisher:
ISBN:
Category : United States
Languages : en
Pages : 802

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Author: United States. Congress
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 804

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The Congressional Record is the official record of the proceedings and debates of the United States Congress. It is published daily when Congress is in session. The Congressional Record began publication in 1873. Debates for sessions prior to 1873 are recorded in The Debates and Proceedings in the Congress of the United States (1789-1824), the Register of Debates in Congress (1824-1837), and the Congressional Globe (1833-1873)

Author: Robin Feldman
Publisher: Harvard University Press
ISBN: 0674070178
Category : Law
Languages : en
Pages : 270

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Book Description
Scientific and technological innovations are forcing patent law into the spotlight and revealing its many glaring inadequacies. Take, for example, the patent case that almost shut down the BlackBerry, or the growing phenomenon of patent trolling, in which patents are acquired for the sole purpose of entrapping companies whose products relate to them. And patents on genes have everyone up in arms—and our courts confused. Robin Feldman explains why patents are causing so much trouble. The problem lies in our assumption that patents set clear boundaries for rights to an invention. In reality, they do no such thing. The very nature of inventions makes them impossible to describe unambiguously for all time. When something is so new that we do not understand yet how it works, what it is capable of doing, or how it could be applied—as is often the case in biotechnology—description is necessarily slippery. Instead of hoping for clear boundaries, and moaning when we don’t get them, Rethinking Patent Law urges lawmakers to focus on what the law can do well: craft rules that anticipate the bargaining that will occur as rights unfold. By steering clear of laws that distort the bargaining process, lawmakers can help courts answer difficult questions, such as whether genes, software, and business methods constitute patentable subject matter, whether patents in the life sciences should control inventions that have yet to be discovered, and how to resolve the battles between pharmaceutical companies and generics.

Author: Albert A. Foer
Publisher: Edward Elgar Publishing
ISBN: 0857939602
Category : Law
Languages : en
Pages : 425

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Book Description
Private Enforcement of Antitrust Law in the United States is a comprehensive Handbook, providing a detailed, step-by-step examination of the private enforcement process, as illuminated by many of the country's leading practitioners, experts, and scholars. Written primarily from the viewpoint of the complainant, the Handbook goes well beyond a detailed cataloguing of the substantive and procedural considerations associated with individual and class action antitrust lawsuits by private individuals and businesses. It is a collection of thoughtful essays that delves deeply into practical and strategic considerations attending the decision-making of private practitioners. This eminently readable and authoritative Handbook will prove to be an invaluable resource for anyone associated with the antitrust enterprise, including both inexperienced and seasoned practitioners, law professors and students, testifying and consulting economists, and government officials involved in overlapping public/private actions and remedies.