Download or read book H R 1706 the Protecting Consumer Access to Generic Drugs Act of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection and published by . This book was released on 2012 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book H R 1706 the Protecting Consumer Access to Generic Drugs Act of 2009 written by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Trade, and Consumer Protection and published by . This book was released on 2012 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Report on the Activity of the Committee on Energy and Commerce for the Congress written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on 2011 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book 2009 Annual Review of Antitrust Law Developments written by and published by American Bar Association. This book was released on 2011-07-16 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Legislative Calendar written by United States. Congress. House. Committee on Energy and Commerce and published by . This book was released on with total page 1192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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:
Download or read book Congressional Record Daily Digest of the Congress written by United States. Congress and published by . This book was released on 2009 with total page 802 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 2009 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
Download or read book Rethinking Patent Law written by Robin Feldman and published by Harvard University Press. This book was released on 2012-06-19 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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.
Download or read book Private Enforcement of Antitrust Law in the United States written by Albert A. Foer and published by Edward Elgar Publishing. This book was released on 2012-01-01 with total page 425 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book PLI s Annual Institute on Securities Regulation in Europe written by and published by . This book was released on 2010 with total page 1216 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Annual Proceedings of the Fordham Competition Law Institute written by and published by . This book was released on 2010 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Journal of the American Medical Association written by and published by . This book was released on 2009-05 with total page 812 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book BNA Pension Benefits Reporter written by and published by . This book was released on 2009-07 with total page 1440 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 Food and Drug Administration Advisory Committees written by Institute of Medicine and published by National Academies Press. This book was released on 1992-02-01 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice. Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public. In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.
