Patents law Books

Book SynopsisWritten by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.Key Features: Broad, practitioner-oriented approach offers a useful source of reference alongside practical guidance Analysis of SPC case law in light of developments in pharmaceutical technology, including both legal and technical aspects of the cases Examination of the lack of clarity in interpretation of the legislation and how this might be exploited by stakeholders Pharmaceutical Patents under the SPC Regulation is an indispensable practical resource for patent law practitioners, including patent attorneys and attorneys-at-law in the SPC field. It will also prove useful to national patent authorities, legislators, and academics working at the intersection between pharmaceuticals and legal research.Trade Review‘This book provides an excellent account of the current legal frameworks applying to SPCs, as well as a splendid explanation of why and how new technological developments challenge these. It includes a highly coveted analysis of case law and practice in Europe and provides clear and pragmatic tools to reflect and guide future practice.’ -- Timo Minssen, Centre for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen, Denmark‘Modern pharmaceuticals pose significant challenges to the established SPC system in Europe. It is a highly topical question whether the European SPC Regulation is still fit for purpose. Pragmatic advice, improved legal certainty, but also wider policy proposals are needed. This book includes a comprehensive and competent analysis of case law and practice in Europe and provides clear and pragmatic tools to reflect and guide future practice. This is no surprise, given the author’s experience as a well-known European Patent Attorney in the field. The entire sector is thoroughly analysed and discussed in detail while at the same time always keeping in mind the high-level perspective and not getting lost in details. In short: This book belongs on the desk of every practitioner in the field and is at the same time interesting for academics.’ -- Matthias Leistner, Ludwig-Maximilians-Universität München, GermanyTable of ContentsContents: Preface PART I INTRODUCTION AND CONTEXT 1. Introduction to Pharmaceutical Patents under the SPC Regulation 2. The Pharmaceutical Industry and the Surrounding Legal and Economic Environment PART II LEGAL ANALYSIS OF THE SPC REGULATION AS IT IS 3. Background and Purpose of the SPC System 4. Definition of “Product” and “Medicinal Product” 5. Eligibility for Protection of (Medicinal) Products under the SPC System 6. Conditions for Obtaining a Certificate (Art. 3) 7. Subject Matter of Protection (Art. 4) and Effects of the Certificate (Art. 5) 8. Conclusion on the Law as it is PART III LEGAL ANALYSIS OF THE SPC REGULATION WITH REGARD TO MODERN PHARMACEUTICAL INNOVATION 9. SPC protection for biotechnological medicinal products 10. Secondary innovation PART IV GENERAL FINDINGS AND FUTURE PROPOSALS 11. General Findings and Future Proposals Bibliography Index

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Book SynopsisIn Pharmanomics, investigative journalist Nick Dearden digs down into the way we produce our medicines and finds that Big Pharma is failing us, with catastrophic consequences.Big Pharma is more interested in profit than health. This was made clear as governments rushed to produce vaccines during the Covid pandemic. Behind the much-trumpeted scientific breakthroughs, major companies found new ways of gouging billions from governments in the West while abandoning the Global South. But this is only the latest episode in a long history of financialising medicine - from Purdue's rapacious marketing of highly addictive OxyContin, through Martin Shkreli's hiking the price of a lifesaving drug, to the 4.5 million South Africans needlessly deprived of HIV/AIDS medication.Since the 1990s, Big Pharma has gone out of its way to protect its property through the patent system. As a result, the business has focused not on researching new medicines but on building monopolies. This system has helped restructure our economy away from invention and production in order to benefit financial markets. It has fundamentally reshaped the relationship between richer and poorer countries, as the access to new medicines and the permission to manufacture them is ruthlessly policed. In response, Dearden offers a pathway to a fairer, safer system for all.Trade ReviewNick Dearden's book is about the structural foundations of a global market in life-saving medicines. A market dependent on taxpayer subsidies, but designed to strip both rich and poor governments of the power to improve health. An essential read for those that care about saving lives, and that want the system changed. -- Ann Pettifor, author of A Case for the Green New Dealbrings together detailed investigative research with lessons from the frontlines of the fight for access to medicines. It exposes a global apartheid in which a few mostly white male Pharma bosses make billions while billions of people are left without essential medicines. It exposes how the problem of medical monopolies is not a few rule-breakers but the rules themselves. Most crucially, it shows how the system which put profits over people's lives was man-made, and how through collective action people can unmake it, for everyone's health. -- Winnie Byanyima, UNAIDS Executive Director and United Nations Under-Secretary-GeneralCarefully researched ... Despite the depressingly familiar story of greedy, rapacious capitalism, this is a hopeful book. -- Mike Phipps * Labour Hub *Authoritative, detailed, practical and written with passion ... inspiring -- Clare Sansom * East Anglia Bylines *A fascinating account of the evolution of Big Pharma into a profit-hungry monster that destructively distorts a major component of the world's healthcare systems . an enormously useful book. * Counterfire *Table of ContentsIntroduction: Bad Apples1. A History of Scandal2. A Hedge Fund with a Pharmaceutical Firm Attached3. It Was Greed, My Friends4. The Pandemic Begins5. Recolonising the Global Economy6. The Hospital That Became a Trading Floor7. A New Hope8. Reach for the Moon

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Book SynopsisThis book covers a broad range of legal topics relating to the fields of bioinformatics and medical informatics, which relate to the intersection of biomedical information and computer programming within the contexts of scientific research, product development and healthcare delivery. A number of usually distinct bodies of legal doctrine come together in this area, sometimes overlapping, sometimes colliding in unexpected ways. Key issues discussed in the book include: An overview of the current landscape of bioinformatics and medical informatics A focus on the legal issues arising from the development and acquisition of informatics tools for use in a laboratory or healthcare setting Developments in patent and innovation law that are important for informatics applications A discussion of institutions and collaborative arrangements in which informatics applications are developed and used today Data protection and privacy issues applicable to informatics applications in the U.S. and Europe. While no single work can cover the entire set of legal issues arising from large, dynamic and complex fields such as bioinformatics and medical informatics, this book strives to offer the reader insight into some of the major legal trends and considerations applicable to these fields today.Table of ContentsContents: Preface xvi Introduction to Bioinformatics, Medical Informatics and the Law xxii 1 Overview of bioinformatics and medical informatics technology for non-specialists 1 A. James Cuticchia 2 Medical Information Commons: conceptual, legal and ethical considerations for stakeholders 12 Janis Geary, Mary A. Majumder, Jill Oliver Robinson, Christi Guerrini and Robert Cook-Deegan 3 Software agreements for bioinformatics and medical informatics applications 31 Brett Lockwood 4 Open source and bioinformatics 44 Michele K. Herman, Jane Eckels, Joanne Montague, Jordan J. Bowler and Nicole Orlov 5 Software development 70 Heather J. Meeker 6 Software patents 80 Gregory J. Kirsch and Charley F. Brown 7 Bioinformatics at the Patent Office 120 Saurabh Vishnubhakat and Arti K. Rai 8 University research and licensing 133 Jeff Carter-Johnson, Jennifer Carter-Johnson and Jorge L. Contreras 9 Technical standards for bioinformatics and medical informatics 153 Jorge L. Contreras and Adrian Thorogood 10 Database protection 180 Jon M. Garon 11 US federal genomic data release and access policies 193 Jorge L. Contreras 12 Privacy and security challenges in bioinformatics 205 Lucy L. Thomson and Arthur E. Peabody, Jr. 13 Bioinformatics, medical informatics and the European General Data Protection Regulation 248 Christopher Jones 14 Informatics and public health surveillance 269 Leslie P. Francis and John G. Francis Index 297

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Book SynopsisBiotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective. Herdegen explores how regulatory approaches to controversial issues such as: stem cell research and cloning and gene therapy differ across jurisdictions due to conflicting values and risk perceptions. The book goes on to examine how international regulatory instruments aim to address these conflicting perspectives and provide judgments based on broad international consensus. Chapters explore the interaction between biotechnology and different fields of law including: human rights, intellectual property, trade law and environmental law. In doing so, a number of complex issues are raised such as the need to balance commercial interests with socio-cultural considerations and the need to ensure respect for human dignity in the pursuit of biomedical research. Providing a concise and accessible guide to a complex field of international law, this book will be of great value to those researching the law and regulation of biotechnology, biomedicine and biodiversity both within the EU and on an international scale. The book will also be a useful resource for practicing lawyers as it includes sources from a diverse range of legal systems and analyses relevant decisions by international adjudicatory bodies.Trade Review'Biotechnology will shape, together with information technology, much of the technological advances in the 21st Century. It affects all walks of life and bears potentials and risks. In international and European law, different areas of law touch upon it without much coherence. Written by a foremost expert, this book makes a most valuable contribution, expounding the interfaces of the different regulatory areas and offering a comprehensive and timely treatise on the subject.' --Thomas Cottier, Chairman ILA Committee on the Biotechnology, UK'This book by Matthias Herdegen provides a unique, thoughtful and comprehensive discussion of the interaction between biotechnologies and international law. Unlike other books in the field, which tend to be confined to biomedical issues, this book covers a broad spectrum of topics, including questions related to environmental protection, risk assessment, genetically modified foods, international trade, and gene patenting. It combines theoretical reflection with the analysis of relevant international instruments and courts judgments.' --Roberto Andorno, University of Zurich, SwitzerlandTable of ContentsContents: 1. Introduction: Regulation of Biotechnology, between Anxieties and Trust in Scientific Progress 2. Law and Ethics: An Intriguing Interplay 3. Risks, Perceptions and the Law: Regulatory Approaches to Risk 4. The Biotech Challenge to Human Dignity, Life and Freedom of Choice: Human Rights 5. From Test Tube Babies to Human Clones: Salient Issues in the International Law of Biomedicine 6. GMOs, Crops and Precaution: Biotechnology and the International Protection of the Environment 7. Combating Biopiracy: Access to Genetic Resources 8. Phantom Risks and Legitimate Concerns: Biotechnology and International Trade Law 9. Inventor’s Claims to Life: Intellectual Property Rights and Biotechnological Inventions 10. Conclusion: Legal Values, Individual Rights and Democratic Choices in a Pluralist World Index

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Book SynopsisThis major Handbook provides a comprehensive research source for patent protection in three major jurisdictions: the United States, Europe and Japan. Leading patent scholars and practitioners join together to give an innovative comparative analysis both of fundamental issues such as patentability, examination procedure and the scope of patent protection, and current issues such as patent protection for industry standards, computer software and business methods. Keeping in mind the important goal of world harmonization, the contributing authors challenge current systems and propose necessary changes for promoting innovation.Providing useful tips for practitioners to protect their intellectual assets in technologies effectively in the global market, this Handbook will be of great interest to legal scholars and students, as well as lawyers and patent attorneys.Trade Review'The editor of Patent Law and Theory must be congratulated for assembling a concentration of sheer patent law erudition and scholarship. The title is a noteworthy compilation of 26 well-written, remarkably accessible and thought-provoking essays that goes to great lengths in charting the contours of contemporary thought over the "the world's oldest regularly established property right". . . it manages to accomplish an ambitious endeavour of providing a comprehensive view of prevailing issues in the field of patent law and other related fields. . . the interested patent law reader will have much to gain from the fecund material found in the large majority of the title's essays. The world's corpus of patent law research is richer with the publication of this title.' -- John A. Tessensohn, European Intellectual Property ReviewTable of ContentsContents: Preface PART I: FOUNDATIONS 1. On the Economics of Patent Law and Policy F. Scott Kieff 2. Patents and Policies for Innovations and Entrepreneurship Ove Granstrand 3. History of the Patent System John N. Adams 4. A Spanner in the Works – Or the Spanner that Works? Patents and the Intellectual Property System Jeremy Phillips 5. International Treaties and Patent Law Harmonization: Today and Beyond Tomoko Miyamoto PART II: INTERNATIONAL AND COMPARATIVE DIMENSIONS: PROCEDURAL ISSUES IN EXAMINATION 6. Examination Procedure at the European Patent Office Peter Watchorn 7. Appeal Procedure before the European Patent Office Andrea Veronese 8. Patent Office Oppositions and Patent Invalidation in Court: Complements or Substitutes? Jay P. Kesan 9. Trilateral Cooperation – Mutual Exploitation of Search and Examination Results Among Patent Offices with a View to Establishing a System of Rationalized Work-Sharing Shinjiro Ono 10. ‘Lost in Translation’: The Legal Impact of Patent Translation Errors on Claim Scope Donald S. Chisum and Stacey J. Farmer PART III: CONDITIONS OF PATENTABILITY: ESSENTIAL REQUIREMENTS 11. Patenting Software-Related Inventions in Europe Stefan Schohe, Christian Appelt and Heinz Goddar 12. Utility and Industrial Applicability Christopher Wadlow 13. The Novelty and Priority Provision under the United States First-to-File Principle: A Comparative Law Perspective Toshiko Takenaka 14. Back to the Graham Factors: Nonobviousness after KSR v. Teleflex Elizabeth A. Richardson PART IV: PATENT ENFORCEMENT ISSUES: EXTENT OF PATENT PROTECTION AND INFRINGEMENT REMEDIES 15. Extent of Patent Protection in the United States, Germany, the United Kingdom and Japan: Examination through the Concept of ‘Person Having Ordinary Skill in the Art of the Invention’ Toshiko Takenaka 16. Direct and Indirect Patent Infringement Alison Firth 17. The Scope of Patent Protection for Spare Parts and its Extension through Other Tools of Intellectual Property Horst-Peter Götting and Sven Hetmank 18. The Exhaustion of Patent Owners’ Rights in the European Community Thomas Hays 19. Enabling Research or Unfair Competition? De Jure and De Facto Research Use Exceptions in Major Technology Countries Sean O’Connor 20. Compulsory Licensing Under TRIPS and the Supreme Court of the United States’ Decision in eBay v. MercExchange Christopher A. Cotropia 21. Adequate Compensation for Patent Infringement Damages: A Comparative Study of Damage Measurements in Japan and the United States Toshiko Takenaka 22. Resolving Patent Disputes in a Global Economy Rochelle C. Dreyfuss PART V: CORE ISSUES IN THE FUTURE? 23. Challenges to the Sui Generis Regime of Pharmaceutical Patents John R. Thomas 24. Current Controversies Concerning Patent Rights and Public Health in a World of International Norms Cynthia M. Ho 25. Biotechnology Patent Pools and Standards Setting Jorge A. Goldstein 26. Patenting Industry Standards Vincent F. Chiappetta Index

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Book SynopsisPatents summarizes four decades of pioneering research by F.M. Scherer on the economics of patent protection. This book is distinguished by concern for the role of patents in a global context and by thorough investigation into the utility of patent counts as instruments for measuring the magnitude and consequences of technological invention. The book also includes a detailed new introduction by F.M. Scherer.The seminal essays contained within the book are organized around three principal foci: how to identify and shape policies yielding optimal patent protection in domestic and international markets; using patent data to reveal important features of the economy; and interpreting the economic significance of patents as measures of innovation. Explored under the second focus are the relationships of patenting to firm size, market structure, demand, and how inventions flow through the economy to yield productivity gains. The third focus illuminates implications of the highly skewed distribution of individual patent values.Scholars working on innovation and science, technological change, and law and economics will find this an invaluable and interesting book. It will also appeal to practitioners involved in patent and antitrust matters.Trade Review'The volume gives the reader the benefits of diagrams, figures and charts to illustrate the text, and it is richly footnoted, very thoroughly indexed, and fine textured throughout. Every paragraph contains specific references, examples, and notes. . . this book is a collection of major contributions to the important array of issues in the economics of patent system. It represents the collection of works on analyzing and modelling methodologies based on the patent data. This volume is a major contribution not only to the history of research in the patent system, but also to the understanding of a good deal of why the concept of patenting has evolved in economics in the global context as it has. . . I would say this is a book for academics, practitioners who have a background in statistical analysis and econometric modelling, and advanced students interested in the concept of patenting and the analysis of patent data.' -- Guldem Gokcek, Prometheus'Taken together, these papers make accessible a wide range of patent-related economic and policy issues. . . the papers in the present book give a very good exposure to significant issues involving innovation. Both specialists in innovation and general industrial organization economists will find much interesting material in this collection.' -- David Sibley, Journal of Economic Literature'The Scherer book is an economist's delight. . . this collection is full of thoughtful insights and quirky corrections to accepted stylised facts. . . The overwhelming impression of this work is that researchers like Scherer work hard at thinking about the real issues and then test their ideas rigorously.' -- John Yeabsley, NZ Law JournalTable of ContentsContents: Introduction Part I: Economic Analysis and Policy 1. The Economics of the Patent System 2. Nordhaus’ Theory of Optimal Patent Life: A Geometric Interpretation 3. Comment on Edmund Kitch 4. The Economics of Human Gene Patents 5. The Pharmaceutical Industry and World Intellectual Property Standards 6. Economic Effects of Strengthening Pharmaceutical Patent Protection in Italy 7. Post-TRIPS Options for Access to Patented Medicines in Developing Nations 8. A Note on Global Welfare in Pharmaceutical Patenting Part II: Using Patent Data to Measure Technological Innovation 9. Firm Size, Market Structure, Opportunity, and the Output of Patented Interventions 10. Corporate Inventive Output, Profits, and Growth 11. Inter-Industry Technology Flows in the United States 12. Demand-Pull and Technological Invention: Schmookler Revisited 13. The Propensity to Patent 14. Technology Flows Matrix Estimation Revisited Part III: What Do the Measures Measure? 15. The Office of Technology Assessment and Forecast Industry Concordance as a Means of Identifying Industry Technology Origins 16. Exploring the Tail of Patent Invention Value Distributions 17. Citation Frequency and the Value of Patented Inventions Part IV: The Road Ahead 18. The Innovation Lottery Index

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Book SynopsisContemporary patent law continues to struggle with the most basic questions of patent system design. There is fierce debate over the power of the Patent Office, the role of the courts, incentives to guide the process and many other fundamental issues. Professor Miller brings together seminal articles which are acknowledged to be the proper foundations for these ongoing debates. This indispensable collection of papers is vital for patent policy makers and serves as an excellent reference source for anyone with an interest in the topic.Trade Review‘This collection of essays forms a wonderful introduction to patent law practice, its theory, and its problems. It includes highly influential articles by top thinkers in the field. Furthermore, it exposes readers to all of the key methodologies - economic and empirical analysis, historical research, normative assessment - necessary to acquire a deep understanding of the field.’ -- Rochelle Dreyfuss, New York University, School of Law, US‘This is a timely collection of many of the major milestones in recent patent theory. The problems they address remain core to the ongoing utility of the patent system.’ -- Michael Spence, University of Sydney, AustraliaTable of ContentsContents: Acknowledgements Introduction Joseph Scott Miller PART I PATENT LAW HISTORY 1. P.J. Federico ([1936] 1990), ‘Operation of the Patent Act of 1790’ 2. Steven Lubar (1991), ‘The Transformation of Antebellum Patent Law’ 3. Mark D. Janis (2002), ‘Patent Abolitionism’ 4. Edward C. Walterscheid (2005), ‘The Hotchkiss Unobviousness Standard: Early Judicial Activism in the Patent Law’ PART II NONOBVIOUSNESS 5. Edmund W. Kitch (1966), ‘Graham v. John Deere Co.: New Standards for Patents’ 6. John F. Duffy (2008), ‘A Timing Approach to Patentability’ PART III ECONOMIC ANALYSIS OF PATENT LAW 7. Robert P. Merges and Richard R. Nelson (1990), ‘On the Complex Economics of Patent Scope’ 8. Suzanne Scotchmer (1991), ‘Standing on the Shoulders of Giants: Cumulative Research and the Patent Law’ 9. Edmund W. Kitch (1977), ‘The Nature and Function of the Patent System’ 10. John F. Duffy (2004), ‘Rethinking the Prospect Theory of Patents’ 11. Paul J. Heald (2005), ‘A Transaction Costs Theory of Patent Law’ PART IV THE PATENABILITY OF SOFTWARE OR BUSINESS METHODS 12. Donald S. Chisum (1986), ‘The Patentability of Algorithms’ 13. Allen Newell (1986), ‘Response: The Models Are Broken, The Models Are Broken!’ 14. Thomas F. Cotter (2007), ‘A Burkean Perspective on Patent Eligibility’ PART V EMPIRICAL ANALYSIS OF PATENT LAW 15. Bronwyn H. Hall and Rosemarie Ham Ziedonis (2001), ‘The Patent Paradox Revisited: An Empirical Study of Patenting in the U.S. Semiconductor Industry, 1979–1995’ 16. John R. Allison, Mark A. Lemley, Kimberly A. Moore and R. Derek Trunkey (2004), ‘Valuable Patents’ Name Index

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Book SynopsisThe 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.Contributors: M.A. Bader, O. Gassmann, H. Goddar, M. Granieri, K. Laursen, M.I. Leone, S. Morricone, U. Moser, F. Munari, M.C. Odasso, N. Omland, R. Oriani, L. Sereno, M. Sobrero, L. Toschi, P.M. ValentiTrade Review'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'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, BerkeleyTable of ContentsContents: Introduction Federico Munari and Raffaele Oriani PART I: PERSPECTIVES ON PATENT VALUE 1. Why, When and How to Value Patents? An Introduction Federico Munari and Raffaele Oriani 2. A Law and Economics Introduction to Patent Law and Procedure Massimiliano Granieri 3. Economic and Management Perspectives on the Value of Patents Federico Munari and Maurizio Sobrero 4. Patent Exploitation Strategies and Value Creation Maria Isabella Leone and Keld Laursen PART II: PATENT VALUATION METHODS 5. Traditional Valuation Methods: Cost, Market and Income Approach Heinz Goddar and Ulrich Moser 6. Advanced Valuation Methods: The Real Options Approach Raffaele Oriani and Luigi Sereno 7. Valuing Patents through Indicators Nils Omland PART III: PATENT VALUATION CONTEXTS 8. Patent Portfolio Management Martin A. Bader and Oliver Gassmann 9. Patent Licensing Contracts Massimiliano Granieri, Maria Isabella Leone and Raffaele Oriani 10. Economic Approaches to Patent Damages Analysis Paola Maria Valenti 11. Valuing Patents for Accounting Purposes Serena Morricone 12. Patent-backed Finance Federico Munari, Maria Cristina Odasso and Laura Toschi 13. Stock Market Valuation of Patent Portfolios Serena Morricone and Raffaele Oriani Index

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Book SynopsisThe supplementary protection certificate (SPC) prolongs the term of patents for pharmaceutical products for a maximum of five additional years. The SPC's legal bases are two European SPC Regulations and the SPC is based upon European or national patents. SPCs protect some of the most valuable products in the pharmaceutical industry where each day of additional protection may be worth millions of Euros. Despite the economic relevance SPCs have obtained in recent years, there exists only limited detailed literature on the subject. German jurisprudence on SPCs is of special importance, as this has often been the basis for decisions of the European Court of Justice (ECJ) and the German market is one of the leading markets for pharmaceuticals and thus for SPCs. This book is addressed to patent attorneys - in particular in-house and external - working for pharmaceutical companies, and attorneys-at-law specialising in patent law, especially in Europe but essentially worldwide.Table of ContentsPART I GENERALS OF THE SUPPLEMENTARY PROTECTION CERTIFICATE IN THE EUROPEAN LAW A. Purpose, History and Legal Character of the Certificate B. Substantive Granting Prerequisites C. Calculation of Term D. Subject Matter and Scope of Protection E. Rights, Limitations and Obligations F. Grant Procedure G. Expiry, Invalidity and Revocation H. Remedies PART II SPECIALITIES IN OTHER JURISDICTIONS I. The SPC in Germany J. The SPC in the United Kingdom K. The SPC in France L. The SPC in Italy M. The SPC in The Netherlands N. The SPC in Switzerland ANNEXES Annex A: Selected Decisions of the European and Swiss Case Law A1. Court of Justice of the European Union A2. German Courts A3. UK Courts A4. French Courts A5. Italian Courts A6. Dutch Courts A7. Swiss Courts Annex B: Selected Legal Sources B1. International Treaties B2. European Primary Law B3. European Regulations B4. European Directives B5. National Law

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Book SynopsisThis insightful book reviews the inherent conflict between patent rights and industry standards and through analysis of both US and European case law proposes measures to improve current systems and foster greater innovation.Jae Hun Park searches for the appropriate balance between the rights of patent owners and the need for industry standards within the scope of patent law. He considers the current solutions provided by legal systems and using cost?benefit analysis evaluates, from a legal and economic perspective, whether patent systems can be improved. Jae Hun Park proposes reform to the patent system that would introduce a ?dynamic liability rule regime?, rather than ?property rules?. The ?dynamic liability rule regime? adopts property rules at the stage when there are still competing standards, and liability rules at the stage when there are no competing standards. This would, he argues, resolve the conflict between patents and standards and mitigate the patent hold-up problem.This is a must-read book for scholars interested in technology patents, innovation and competition law and policy, as well as those individuals working in standard setting organisations. It will also be of great interest to patent offices, patent attorneys and competition lawyers.Trade Review‘Dr Jae Park is to be congratulated for turning our attention to this difficult and underexplored area. His work focuses on standards and patents but goes well beyond an initial first analysis. He examines the finer points of both sets of rules in order to find out exactly where the problem lies and he then looks at the existing mechanisms that could provide a solution. Many of these have their roots in the area of competition law, but his thorough analysis shows that competition law in its current form and with its current limitations is not the perfect tool to address the problems that arise when patented technology becomes the object of standardisation. This leads Dr Park to develop his own solution for the problem at hand: a solution which he finds in the dynamic liability rules regime. This book really breaks new ground and provides a first and thorough analysis of this rarely addressed but increasingly important area.’ -- From the foreword by Paul L.C. Torremans, University of Nottingham, UKTable of ContentsContents: Foreword by Paul L.C. Torremans 1. Introduction 2. Industry Standards 3. Patents and Standards in the US 4. Patents and Standards in the EU 5. Patent Laws and Standards 6. Costs and Benefits of Patent Systems 7. Alternative Solutions and a Suggested Solution 8. Conclusion References Index

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Book SynopsisThe new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic. New technological sectors have emerged, each one with its own features with regard to innovation process and pace. From the most controversial cases in biotech to the most recent decisions in the field of software and business methods patent, patent law has tried to stretch its boundaries in a way to accommodate such new and controversial subject matters into its realm. Biotechnology and Software Patent Law will strongly appeal to postgraduate students specializing in IP law, international law, commercial and business law, competition law as well as IP scholars, academics and lawyers. Contributors: S.D. Anderman, R.B. Bakels, S.J.R. Bostyn, D.L. Burk, V. Di Cataldo, V. Falce, C. Geiger, R.M. Hilty, C.M. Holman, M.A. Lemley, A. Ottolia, J. Pila, J.R. Thomas, P.L.C. TorremansTrade Review‘If you are an IP lawyer, or academic, or possibly a graduate student in commercial, or competition law, this book will lead you down some fascinating avenues for discussion and debate on many of the critical issues now confronting patent law today.’ -- Phillip Taylor MBE and Elizabeth Taylor, The Barrister Magazine‘The art of editing is to bring contributions together, which melt into one book. This is what Emanuela Arezzo and Gustavo Ghidini have achieved with their own critical mind by composing a book of papers, in which internationally renowned experts measure the tensions created for the patent system by the needs and problems of protecting biotechnological and software inventions. All together, they present a comparative law challenge to the very fundaments of patent protection. As such, they are or may become a “must read”.’ -- Hanns Ullrich, College of Europe, Bruges, Belgium‘Arezzo and Ghidini have put together a fine collection of essays addressing developments in patent law – from general themes to emerging ones in the infotech and biotech sectors. It is notable that the international array of authors includes contributions from both established and rising young scholars, all of them ably tackling difficult issues that merit our attention.’ -- Rudolph J.R. Peritz, New York Law School, USTable of ContentsContents: Introduction Emanuela Arezzo and Gustavo Ghidini PART I: GENERAL THEMES IN PATENT LAW 1. Tailoring Patents to Different Industries Dan L. Burk and Mark A. Lemley 2. Innovation in the New Technological Industries: Looking for a Consistent Cooperative Model Valeria Falce 3. The Future of the Requirement for an Invention: Inherent Patentability as a Pre- and Post-Patent Determinant Justine Pila 4. The Experimental Use of the Patented Invention: A Free Use or an Infringing Use? Vincenzo Di Cataldo 5. Patents and Competition Law: Some Features of the New Interface Steven D. Anderman PART II: EMERGING THEMES IN INFORMATION TECHNOLOGIES 6. Are Software Patents Something Special? Reinier B. Bakels 7. Towards a New Instrument of Protection for Software in the EU? Learning the Lessons from the Harmonization Failure of Software Patentability Reto M. Hilty and Christophe Geiger 8. Patent Governance in the United States: Lessons from Bilski v. Kappos John R. Thomas PART III: EMERGING THEMES IN THE BIOTECH INDUSTRIES 9. A Decade After the Birth of the Biotech Directive: Was it Worth the Trouble? Sven J.R. Bostyn 10. Gene Patents Under Fire: Weighing the Costs and Benefits Christopher M. Holman 11. Patentability of Human Stem Cell or Synthetic Biology Based Inventions Paul L.C. Torremans 12. Moral Limits to Biotech Patents in Europe: A Quest for Higher Harmonization Andrea Ottolia Index

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Book SynopsisThis book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. It first considers the historical basis for exclusion and the development of law and policy in Europe, the United States and other commonwealth countries. The book goes on to provide a detailed analysis of the issues related to new medical technologies, such as gene therapy, dosage regimes, and medical diagnostics, in light of the medical treatment exclusion. Medical Patent Law will strongly appeal to patent agents and attorneys, solicitors and barristers working in patent and intellectual property law and medical law worldwide, as well as medical practitioners and healthcare professionals; scientists, researchers and managers in the chemicals, medical; pharmaceuticals and biotechnology industries. Postgraduates on LLM medical law and intellectual property courses and academics specializing in medical law or patent law, will also find much to interest them.Trade Review‘Ventose makes a fresh, lively and incredibly thorough contribution to the literature in this work. He canvasses the European, English and American authorities in a systematic, methodical and - dare I say - surgical manner. The book is a ‘must read’ for practitioners, academics and students alike interested in patentable subject matter, public policy and medico-legal ethics. It will be a welcome addition to any legal collection.’ -- Emir Aly Crowne, University of Windsor, Barrister & Solicitor, Law Society of Upper Canada and Co-Founder and Co-Chair, Harold G. Fox Intellectual Property Moot‘Medical patents are a matter of life and death. Such patents have a critical impact upon patient care, medical research, and the administration of healthcare (and, indeed, are in part responsible for ballooning health care budgets). This comprehensive book by Eddy D. Ventose provides a systematic comparative analysis of medical patents. The work explores the historical taboo against patenting methods of human treatment; charts the spectrum of policy positions on medical patents, ranging from permissive to prohibitive; and examines contemporary battles over patenting methods of medical correlation in the Supreme Court of United States.’ -- Matthew Rimmer, The Australian National University College of Law and ACIPA, AustraliaTable of ContentsContents: Foreword Preface 1. Introduction 2. Arguments for Patent Protection 3. Arguments Against Patent Protection 4. Therapeutic Methods 5. Surgical Methods 6. Diagnostic Methods 7. Second and Further Medical Uses 8. Manner of New Manufacture 9. United Kingdom Patents Act 2004 10. United States of America 11. Conclusions Bibliography Index

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Book Synopsis

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Book Synopsis

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Book Synopsis

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Book Synopsis

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Book Synopsis

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Book Synopsis

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Book Synopsis

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Book Synopsis

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