Download or read book Patent portfolios and pharmaceuticals a European perspective written by AREZZO EMANUELA and published by Giappichelli. This book was released on 2023-02-07 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes undertakings’ tendency today to protect their intangible technical property through a portfolio of patents. Such trend is in part triggered by the very same feature of modern innovation which, being today complex and cumulative, demands for more patents to efficiently protect its inventive trail. At the same time, undertakings have come to realize that the patent portfolio vests its owner with a set of strategic advantages which exceed by far the mere excluding powers conferred by the patents contained therein. The latter circumstance igniting a vicious circle, whereby firms patent more and more. While fully compliant with patent law, portfolios may cause dangerous drawbacks for competing innovators, as the cluster builds up entry barriers sometimes very hard to surpass. This all the more so in the pharmaceutical sector where the portfolios can be successfully implemented against both originators and generic companies, hence threatening the entrance of generic drugs and biosimilars. The book provides for an in-depth analysis of patent law substantive – as well as procedural – provisions allowing to build patent portfolios in the pharmaceutical sector. It then moves to analyze cases where patent portfolios have been implemented to the goal of foreclosing access to competitors, and the different outcomes provided with by patent law and by competition law.
Download or read book Pharmaceutical Patents in Europe written by Bengt Domeij and published by BRILL. This book was released on 2021-10-25 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: The pharmaceutical industry and patent legislation are inextricably linked. Pharmaceutical companies could not exist without some guarantee that they can recoup the cost of developing a new product. European patent law offers this opportunity, as it allows companies to exclude competition for a specific product for a fixed time scale. In Pharmaceutical Patents in Europe the current legal patent situation is examined by a detailed analysis of case law from the European Patent Office (EPO), the international body created with the signing of the European Patent Convention (EPC). Aspects of European patent law not primarily regulated in the EPC, for example Supplementary Protection Certificates and infringement matters, are examined in the setting provided by EC law and domestic laws of European states. This book is written for the reader who understands the main characteristics of patent law and is looking for a practitioner's text on the European pharmaceutical patent law scene. Moreover, the author's remarks can help all readers to look at the field with fresh eyes.
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 Patents for Chemicals Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press. This book was released on 1999-01-01 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: The chemicals, pharmaceuticals and biotechnology industries worldwide rely upon being able to patent inventions in order to protect investment in research and development, and to reap commercial rewards. This book guides the reader through the legal and procedural complexities of the British, European, Japanese and US patent systems, and explains in detail the role of patent practitioners (both in-house and in private practice) in maximising the commercial potential of their client's or company's innovative products. This is the third edition of the author's highly acclaimed Patents for Chemists. It provides vital updating and much expanded coverage, while retaining the focus upon the relevant technology and industry practices that sets it apart from more general books on patent law and procedure. Patents for Chemicals, Pharmaceuticals and Biotechnology provides a complete description of the techniques and industry know-how that underlie successful patent practice and portfolio management and will be invaluable to all patent agents and practitioners working in the area of patent law. With its lucid and accessible presentation and practical approach, this book will also be welcomed by scientists, researchers and managers without a legal background. FROM THE REVIEWS OF PREVIOUS EDITIONS `Dr Grubb thoroughly exposes the patent system in a way with which few of his professional peers will quarrel, and his book should be in every chemical/biological patent department library' European Intellectual Property Review `an excellent book for anyone interested in patents' International Review of Industrial Property and Copyright Law `a sensible, practical appraisal of the case law and decisions - easy to read and very informative' CIPA Journal `[A] sterling feature of this work is its truly global perspective' Journal of the Patent and Trademark Office Society (US)
Download or read book The Global Politics of Pharmaceutical Monopoly Power written by Ellen F. M. 't Hoen and published by . This book was released on 2009 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.
Download or read book Guidelines for Preparing Patent Landscape Reports written by World Intellectual Property Organization and published by WIPO. This book was released on 2015-08-24 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: These Guidelines are designed both for general users of patent information, as well as for those involved in producing Patent Landscape Reports (PLRs). They provide step-by-step instructions on how to prepare a PLR, as well as background information such as objectives, patent analytics, concepts and frameworks.
Download or read book Global Competitiveness in Pharmaceuticals written by Alfonso Gambardella and published by . This book was released on 2000 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceuticals is a large, high-growth, globalized, & innovation intensive industry. Pharmaceuticals has long been a stronghold of the European industry, & it still provides by far the largest contribution to the European trade balance in high-technology, R&D intensive sectors. However, it is now a diffused perception that the European pharmaceutical industry is losing ground vis-a-vis the U.S. Against this background, the Report examines the competitive position of the European pharmaceutical companies & industries, & compares them with the pharmaceutical companies & industries in other parts of the world, particularly the U.S. Charts, tables & graphs.
Download or read book Patents for Chemicals Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press, USA. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The nature and origins of patent rights -- Historical developments -- Harmonization of patent law -- What can be patented -- Filing a patent application -- Obtaining a granted patent : patent cooperation treaty procedure -- Obtaining a granted patent : European patent office procedure -- Obtaining a granted patent : national procedures -- Maintaining a patent in force and extending the patent term -- Enforcing patent rights -- Invalidity and amendment of granted patents -- Chemical inventions -- Pharmaceutical inventions -- Biotechnological inventions -- Patenting of genes, plants, and animals -- The patent practitioner and his function -- Drafting the patent specification -- Drafting the claims -- Prosecution of the patent application to grant -- Inventorship, ownership, and compensation -- Commercial exploitation of patents -- How to catch the infringer and how not to be caught -- Patent aspects of licensing -- Patents and competition law : United Kingdom and European Union -- Patents and competition law : United States
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Intellectual Property Strategy written by John Palfrey and published by MIT Press. This book was released on 2011-10-07 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt: How a flexible and creative approach to intellectual property can help an organization accomplish goals ranging from building market share to expanding an industry. Most managers leave intellectual property issues to the legal department, unaware that an organization's intellectual property can help accomplish a range of management goals, from accessing new markets to improving existing products to generating new revenue streams. In this book, intellectual property expert and Harvard Law School professor John Palfrey offers a short briefing on intellectual property strategy for corporate managers and nonprofit administrators. Palfrey argues for strategies that go beyond the traditional highly restrictive “sword and shield” approach, suggesting that flexibility and creativity are essential to a profitable long-term intellectual property strategy—especially in an era of changing attitudes about media. Intellectual property, writes Palfrey, should be considered a key strategic asset class. Almost every organization has an intellectual property portfolio of some value and therefore the need for an intellectual property strategy. A brand, for example, is an important form of intellectual property, as is any information managed and produced by an organization. Palfrey identifies the essential areas of intellectual property—patent, copyright, trademark, and trade secret—and describes strategic approaches to each in a variety of organizational contexts, based on four basic steps. The most innovative organizations employ multiple intellectual property approaches, depending on the situation, asking hard, context-specific questions. By doing so, they achieve both short- and long-term benefits while positioning themselves for success in the global information economy.
Download or read book Research Handbook on Methods and Models of Competition Law written by Deborah Healey and published by Edward Elgar Publishing. This book was released on 2020-11-27 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive Handbook illuminates the objectives and economics behind competition law. It takes a global comparative approach to explore competition law and policy in a range of jurisdictions with differing political economies, legal systems and stages of development. A set of expert international contributors examine the operation and enforcement of competition law around the world in order to globalize discussions surrounding the foundational issues of this topic. In doing so, they not only reveal the range of approaches to competition law, but also identify certain basic economic concepts and types of anticompetitive conduct that are at the core of competition law.
Download or read book Achieving Proof of Concept in Drug Discovery and Development written by Helen Yu and published by Edward Elgar Publishing. This book was released on 2016-11-25 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
Download or read book Innovation Economic Development and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.
Download or read book The Interface Between Intellectual Property Rights and Competition Policy written by Steven D. Anderman and published by Cambridge University Press. This book was released on 2007-05-10 with total page 547 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose of this book is to examine the experience of a number of countries in grappling with the problems of reconciling the two fields of competition policy and intellectual property rights. The first part of the book indicates the variation in legislative models as well as the wide variety of judicial and administrative doctrines that have been used. The jurisdictions selected for study are the three major trading blocks with the longest experience of case law (the EU, the USA and Japan) and three less populous countries with open economies (Australia, Ireland and Singapore). In the second part of the book we look at a number of issues closely related to the interface between competition law and intellectual property rights. Separate chapters analyse the issue of parallel trading and exhaustion of IPRs, the issue of technology transfer, and the economics of the interface between intellectual property and competition law.
Download or read book Biotechnology and the Patent System written by Claude E. Barfield and published by A E I Press. This book was released on 2007 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.
Download or read book The Economic Valuation of Patents written by Federico Munari and published by Edward Elgar Publishing. This book was released on 2011-10-01 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book fills an important gap in the literature and will be very useful both to students of intellectual property and practitioners confronted by the problem of valuing their patent portfolios. An excellent overview of an evolving and challenging area, it provides the necessary background to thinking about the problem of valuation and describes all the major methods in use, including the real options approach. Bronywn H. Hall, University of California, Berkeley, US In depth knowledge and scientific approach are used to improve patent valuation techniques. . . a dream book for both researchers and practitioners interested in identifying the value of creative minds. Bruno van Pottelsberghe, Solvay Brussels School of Economics and Management, ULB, Belgium The Economic Valuation of Patents provides an original and essential analysis of patent valuation, presenting the main methodologies to value patents in different contexts. Starting with an analysis of the relevance of patent valuation from a strategic, economic and legal perspective, the book undertakes a thorough review of the existing financial and qualitative valuation methodologies. The contributing authors, IP experts from academia and business, discuss the application of valuation issues in various contexts such as patent portfolio management, licensing agreements, IP litigation, IP-backed finance and accounting. For each topic, an introductory theoretical background is provided and specific application contexts are then investigated. This multidisciplinary book bridges theory and practice in a unique and novel way that will be appreciated by graduate students, scholars and practitioners alike.
Download or read book Contemporary Issues in Pharmaceutical Patent Law written by Bryan Mercurio and published by Routledge. This book was released on 2017-02-17 with total page 271 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges
