Competition and Patent Law in the Pharmaceutical Sector


Book Description

Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?




The Changing Economics of Medical Technology


Book Description

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.




Patent Strategy in Pharmaceutical Industry


Book Description

This book investigates lifecycle management strategies used by pharmaceutical companies attempting to maximize the value of their product portfolio. Such strategies are sometimes referred to by generic drug companies as "evergreening". The analysis focuses on two of these strategies, namely product improvements and product line extensions. In particular, an evaluation of the patents that follow the basic one and that accompany the development of a drug from research to market is attempted. Two "blockbuster" drugs, Taxotere and Xalatan, were randomly chosen to carry out such analysis. The patent portfolio of the originator companies is outlined and some important patents for each area of research (e.g. formulations, combinations, delivery devices) are shortly described. Patent filing trends for the two drugs, both in regards of the originator and in regards of other competing companies (amongst these also the generics) are schematically shown.




Global Dimensions of Intellectual Property Rights in Science and Technology


Book Description

As technological developments multiply around the globeâ€"even as the patenting of human genes comes under serious discussionâ€"nations, companies, and researchers find themselves in conflict over intellectual property rights (IPRs). Now, an international group of experts presents the first multidisciplinary look at IPRs in an age of explosive growth in science and technology. This thought-provoking volume offers an update on current international IPR negotiations and includes case studies on software, computer chips, optoelectronics, and biotechnologyâ€"areas characterized by high development cost and easy reproducibility. The volume covers these and other issues: Modern economic theory as a basis for approaching international IPRs. U.S. intellectual property practices versus those in Japan, India, the European Community, and the developing and newly industrializing countries. Trends in science and technology and how they affect IPRs. Pros and cons of a uniform international IPRs regime versus a system reflecting national differences.




The Global Politics of Pharmaceutical Monopoly Power


Book Description

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.




Patents in the Knowledge-Based Economy


Book Description

This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.




Pharmaceutical Innovation, Competition and Patent Law


Book Description

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.







Patent Protection for Second Medical Uses


Book Description

When a party develops a ‘second medical use’ for a known substance or compound, special issues of patentability arise. Jurisdictions around the world vary significantly in their treatment of such claims. This detailed country-by-country analysis provides clarity, insight, and guidance on the legal issues and practical implications of second medical use claims in nineteen jurisdictions worldwide as well as the European Union. The authors of the country chapters have been carefully selected based on a broad basis of experience and in-depth knowledge about medical patents in their respective jurisdictions. Each chapter considers such issues and topics as the following: • availability of protection; • validity of claims; • scope of protection; • enforcement; and • infringement. A general chapter about the practice of the European Patent Office (EPO) addresses in particular the latest changes in the format of second medical use claims from the “Swiss-type claims” to the “EPC 2000 claims”. Specific issues and national peculiarities which deviate from the EPO practice are explained in the various national European chapters, while chapters on jurisdictions outside Europe cover both prosecution and enforcement of patents with second medical use claims. As a comparative law study and a collection of contributions from around the world on an important and controversial field, this book will prove of tremendous practical interest for the industry involved and for the public. Applicants for pharmaceutical patents, third parties, and interested legal practitioners will benefit greatly from its thorough comparative analysis and guidance. This book is the second volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI).




The Interface Between Intellectual Property Rights and Competition Policy


Book Description

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.