Patents law Books

Book SynopsisThe second edition of this acclaimed and widely-used book has been thoroughly updated in light of, among others, the revised Rules of Procedure of the Boards of Appeal, which entered into force in January 2020. It provides the first detailed understanding of these new rules and their influence on opposition and appeal proceedings. This second edition gives valuable guidance on how to: draft and prosecute patent applications to avoid problems later on in opposition and appeal properly attack or defend a patent react if the patent is amended argue in case of late filings act in oral proceedings. Dealing with all stages of proceedings before the EPO, this book provides fresh insight into how best to act at each stage to successfully complete a case in opposition and appeal, detailing how opposition divisions and boards of appeal approach the cases before them. Experienced practitioners will find that the detailed case law citation adds depth to their knowledge. The 'practical advice' sections and 'example cases' provide patent lawyers and attorneys with invaluable guidance on specific procedural and substantive questions.Trade Review'The book is an excellent read for anyone preparing for their first oppositions or appeals, as it gives a very good overview with practical tips as well as common pitfalls to avoid. For the more experienced ones, the big benefit of the book is the abundant references to case law. A section I particularly appreciated was the very clear and explicit explanation of hearing of witnesses. Another big bonus is of course the references to the 2020 Rules of Procedure of the Boards of Appeal.' --Kaisa Suominen, Moosedog Oy, Finland'This excellent book brings together the theory and practice of opposition and appeal at the European Patent Office. The expert authors explain the legal framework in an accessible manner and provide numerous tips which are based on many years of experience. This book helps you to make the right choices already during drafting the patent application and in opposition so that you will be in the best possible starting position for your appeal under the 2020 Rules of Procedure.' --Nyske Blokhuis, EP&C Patent Attorneys, the Netherlands/BelgiumTable of ContentsContents: Preface 1. Introduction 2. Drafting and prosecution stage 3. Opposition stage 4. Appeal stage – inter partes appeals 5. Appeal stage – ex parte appeals 6. Further issues 7. Conclusion Index

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Book SynopsisLarge-scale, interoperable biobanks are an increasingly important asset in today's life science research and, as a result, multiple types of biobanks are being established around the globe with very different financial, organizational and legal set-ups. With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking.This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are the opportunities and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read.Contributors include: T. Bossow, T.A. Caulfield, B.J. Clark, Å. Hellstadius, J.R. Herrmann, K. Høyer, M. Jordan, J. Kaye, N.C.H. Kongsholm, K. Liddell, J. Liddicoat, M.J. Madison, T. Minssen, B. Murdoch, W. Nicholson Price II, E. Ortega-Paino, M. Prictor, M.B. Rasmussen, K. Sargsyan, J. Schovsbo, A.M. Tupasela, E. van Zimmeren, F. Vogl, H. Yu, P.K. YuTrade Review‘a valuable tool not only for researchers and policymakers, but also to legal practitioners.’ -- Peter Ling, IPkatTable of ContentsContents: Introduction Part I - Biobanks, Big Data and Modes of Collaboration 1. Big Data and the ethics of detail: the role of ethics work in the making of a cross-national research infrastructure for genetic research Klaus Hoeyer, Aaro Tupasela, Malene Bøgehus Rasmussen 2. Biobanks as Knowledge Institutions Michael J. Madison Part II - Biobanks, translational medicine and tech transfer 3. Biobanks as Innovation Infrastructure for Translational Medicine W. Nicholson Price II 4. Responsible Use of Human Biosamples in the Bioscience Industries Brian J Clark and Tina Bossow Part III - Biobanks, Human Rights and Patient Involvement 5. Biobanking, Scientific Productions and Human Rights Peter K. Yu 6. You told me, Right? - Free and Informed Consent in European Patent Law Åsa Hellstadius and Jens Schovsbo 7. Dynamic Consent and Biobanking – A Means of Fostering Sustainability? Jane Kaye and Megan Prictor 8. Generating Trust in Biobanks within the Context of Commercialization: Can Dynamic Consent Overcome Trust Challenges? Esther van Zimmeren 9. Exploitation and vulnerabilities in consent to biobank research in developing countries Nana Cecilie Halmsted Kongsholm 10. Biobanking and the Consent Problem Timothy Caulfield and Blake Murdoch Part IV - Biobanks, Guidelines and Good Governance 11. Responsible Research and Innovation and the Advancement of Biobanking and Biomedical research Helen Yu 12. Do we need an expiration date for biobanks? Franziska Vogl and Karine Sargsyan 13. Biobanks and Biobank Networks Eva Ortega-Paíno and Aaro Tupasela 14. IP Policies for Large Bioresources: the fiction, fantasy and future of openness Kathleen Liddell, Johnathan Liddicoat and Matthew Jordan Index

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Book SynopsisThis book addresses the growing importance of trade secrets in today's society and business and the related increase in litigation, media and scholarly attention. Written by a team of international experts, it uses the new EU Trade Secrets Directive as a prism through which to discuss the complex legal issues involved. Featuring both EU and wider international perspectives, chapters examine the Directive's aim of harmonizing legislation on the protection of trade secrets across the EU, and discuss how this has been implemented by member states. Contributors also explore the effects of the new regime on contentious issues and crucial sectors such as medicine, big data and AI, as well as considering its relationship with US law in particular. Scholars and students of patent law, innovation, and EU law and governance, particularly those with an interest in the topic of information freedom, will find this book of great significance in their research. Practitioners working in trade secrets and intellectual property more broadly will also find this book's comprehensive analysis of the Directive and its practical implications invaluable. Contributors include: T. Aplin, R. Arnold, N. Bruun, R. Cooper Dreyfuss, B. Díaz Alaminos, B. Domeij, N. Lee, T. Minssen, A. Nordberg, A. Ohly, N. Rajam, T. Riis, S.K. Sandeen, J. Schovsbo, J.S. Sherkow, H. Udsen, B. van der Donk, M. van EechoudTrade Review'As the first wave of national implementations of the EU Trade Secrets Directive has hit, it is of great interest to identify the central issues of the new legal framework in different jurisdictions. This timely contribution delivers just that: a number of perspectives from different EU countries give account of their respective national implementation and prepare the stage for a valuable comparative law perspective on the protection of Trade Secrets. Moreover, the book encompasses a cutting-edge assessment of the Directive's effects on topical issues (employee mobility, big data, AI, personalised medicine, etc).' --Matthias Leistner, Ludwig-Maximilians-Universität München, GermanyTable of ContentsContents: I. Introduction Jens Schovsbo, Timo Minssen, Thomas Riis 1. An Appraisal of the EU Directive on Trade Secrets II. The Directive and Its Context 2. The Directive on Trade Secrets and its Background Jens Schovsbo 3. Trade Secret Law as part of Information Law Henrik Udsen, Jens Schovsbo and Berdien van der Donk 4. Through the Looking Glass: Trade Secret Harmonization as a Reflection of U.S.Law Sharon K. Sandeen III. Implementation of the Directive 5. UK Implementation of the Trade Secrets Directive Tanya Aplin and Richard Arnold 6. The Implementation of the Trade Secrets Directive in the Nordic Countries Jens Schovsbo and Niklas Bruun 7. Germany: The Trade Secrets Protection Act of 2019 Ansgar Ohly 8. Implementation of the Trade Secrets Directive into National Law: Portugal and Spain Ana Nordberg and Bárbara Díaz Alaminos IV. Specific issues 9. The Trade Secrets Directive and Employees Bengt Domeij 10. Choice of Law in EU Trade Secrecy Cases Rochelle Cooper Dreyfuss and Mireille van Eechoud 11. Trade Secrets, Big Data and Artifical Intelligence Innovation: a Legal Oxymoron? Ana Nordberg 12. Enforcement of Rights in Trade Secrets Thomas Riis V. Specific sectors 13. AIRR Data Under the E.U. Trade Secrets Directive: Aligning Scientific Practices with Commercial Realities Jakob S. Sherkow and Timo Minssen 14. Protection for Artificial Intelligence in Personalised Medicine–The Patent / Trade Secret Trade Off Nari Lee 15. The Impact of Trade Secrets for Publicly Funded Research Collaborations in Europe Neethu Rajam Index

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Book SynopsisPresenting detailed analysis of the industrialization and commercialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whist also protecting society's right to safe and effective medication.Chapters examine the special application issues of patent law in relation to the field of pharmaceuticals, compare the Chinese and American legal systems and their approach to pharmaceutical patents, and provide in depth political and legal analysis of the industry. James Hou suggests methods by which the Chinese legal system can seek to improve its governance of pharmaceutical patents and balance the conflicts of interest arising between new drug developers, established drug manufacturers and the end users.Featuring comprehensive coverage of patents in the Chinese pharmaceutical industry, this book will be a key resource for scholars and students of commercial, pharmaceutical and intellectual property law, whilst also being of interest to industry talents discovering the potential of their own innovations.Table of ContentsContents: Forward Preface Introduction 1. On the importance of patents in pharmaceutical industry development 2. Pharmaceutical markets and patents: Idealized, and in practice 3. Comparison of Chinese and American legal systems on pharmaceutical patents 4. Patent law issues unique to pharmaceuticals 5. Improvement of China’s pharmaceutical patent system 6. Law and policy analysis of China’s pharmaceutical patent industrialization 7. Conclusion

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Book SynopsisThe intangible capitalist economy, that is intellectual capitalism, continues evolving, driven by technological innovations and various forms of entrepreneurship. The creation of intellectual capital and intellectual properties lies at its heart. This eagerly anticipated book analyzes the many complex links between R&D, patents, innovations, entrepreneurship, growth and value creation in this process. Based on an extensive array of national empirical and policy studies, Ove Granstrand explores a comprehensive range of innovation and intellectual property (IP) issues that pertain not only to Europe but to the entire world. These issues include the role of patents and licensing in the governance of technology and innovation, and the many uses and abuses of patents. The text also details new IP phenomena in an increasingly patent-intensive world with patent-rich multinationals and patent-savvy new entrants from Asia. In a world facing challenges that call for innovative responses, this book contains a set of valuable policy recommendations for strengthening innovativeness for economic growth and ultimately for social value creation. This timely book will be a valuable resource for economics, law and management scholars wishing to gain a thorough understanding of the topic. Practitioners and policy-makers will also greatly benefit from reading this volume, following up on the author's widely acclaimed book published in 1999 The Economics and Management of Intellectual Property: Towards Intellectual Capitalism.Trade Review'Ove Granstrand's excellent monograph titled Evolving Properties of Intellectual Capitalism: Patents and Innovation for Growth and Welfare explores how the innovation system works in advanced economics. At its core is the concept of the ''innovation spiral'' that depicts the interdependence amongst R&D/knowledge, patents/IP, innovation and economic growth and welfare. Its focus on the neglected topic of intangible assets and intellectual capital is timely. The author's focus is primarily European but the relevance of his work is global. The book is a must read for policymakers, a handy reference for managers, and a useful guide for students wishing to understand the many element of innovation policy.' --David Teece, Berkeley Research Group, US'Ove Granstrand's new book is both a broad and deep treatment of his subject. A general reader may value this original and important work for its international comparisons and its treatment of policy as well as more familiar economic issues. A reader with interest in the details of intellectual property may value the work for the penetrating questions asked in the author's research and the wealth of detail and evidence presented. The book is important in its advocacy of seeing patents as a dynamic factor influencing innovation rather than as simply having a static and protective role. Granstrand's treatment will be valuable to executive and political audiences as well as lawyers and economists.' --James M. Utterback, Massachusetts Institute of Technology, US'This is Ove Granstrand's best and most profound work to date. He casts intellectual capitalism as a global system, interfacing a variety of national policy regimes. He shows why the pro-patent era is also pro-licensing, as increasing spatial and organizational interdependencies necessitate shifts in governance structures.' --John Cantwell, Rutgers University, USTable of ContentsContents: Preface 1. Innovation, IP and Intellectual Capitalism 2. Analytical framework 3. Patents and innovations for growth and welfare – a literature review 4. Methodology 5. Patents, innovations and growth – empirical analysis 6. What explains fluctuations in patenting frequency and propensity? 7. Discussion and general innovation and IP policy recommendations 8. Special recommendations for increasing patent knowledge and patenting 9. Patent and Innovation System Developments in Europe, Asia and the US 10. Transnational policy recommendations and policy issues 11. Global innovation and intellectual capitalism 12. Summary and Conclusions References Index

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Book SynopsisThis incisive book examines the role of Intellectual Property (IP) as a complex adaptive system in innovation and the lifecycle of IP intensive assets. Discussing recent innovation trends, it places emphasis on how different forms of intellectual property law can facilitate these trends. Inventors and entrepreneurs are guided through the lifecycle of IP intensive assets that commercialise human creativity.Utilising a range of sector-specific, interdisciplinary and actor-focused approaches, each contribution offers suggestions on how Europe’s capacity to foster innovation-based sustainable economic growth can be enhanced on a global scale. This comprehensive book addresses the role of IP in public–private partnerships and business transactions and further explores how IP law can uphold distributive justice in the innovation society. Chapters span a range of topics of great societal interest, including standard essential patent licensing in the Internet of Things, patent quality concerns under competition law and the role of market-driven and legislative solutions to online music licensing.Intellectual Property as a Complex Adaptive System will be a key resource for students and scholars of IP law, innovation and economics. It will also be vital reading for practitioners, knowledge-intensive industry representatives and innovation and technology transfer specialists.Trade Review‘Intellectual Property as a Complex Adaptive System will serve as a useful source for seasoned researchers and practitioners alike, who are interested in an interdisciplinary approach to IP.’ -- Anastasiia Kyrylenko, The IPKat‘Too often, scholars and policymakers view innovation and creative activity as little more than undifferentiated profit motive that can and should be shaped by government regulation. This refreshing volume demonstrates that the world is far more complex, and that policymakers must understand that complexity before designing successful interventions, which may not take the form of traditional regulation. Everyone who is interested in the future of intellectual property policy needs exposure to the insights in this book.’ -- Robert Brauneis, The George Washington University Law School, US‘The authors use the umbrella of “complex adaptive systems” to expose readers to a selection of topics that demonstrate the increasing complexity of intellectual property law. The chapters, which range from a high-level view of conceptual matters to a detailed review and analysis of legal topics, address a number of important contemporary issues. The volume reveals new complexities that permeate current intellectual property law, and discusses some of the new phenomena that have emerged over the past two to three decades.’ -- Marketa Trimble, University of Nevada, Las Vegas, USTable of ContentsContents: Introduction to Intellectual Property as a Complex Adaptive System xv Anselm Kamperman Sanders and Anke Moerland PART I PATENTS AND INNOVATION 1 Intellectual property as a complex adaptive system 2 Anselm Kamperman Sanders and Anke Moerland 2 Intellectual property rights structures as complex and emergent phenomena 18 David A. Harper 3 How to protect technology: enforcement of patents in Europe today and in the future 43 Christof Augenstein 4 SEP licensing in the Internet of Things: is there a case for a duty to license upstream implementers? 60 Beatriz Conde Gallego 5 Patent quantity concerns under competition law 82 Marco D’Ostuni 6 The machine having ordinary skill in the art 102 Ryan Abbott PART II MARKETS, COLLECTIVE MANAGEMENT AND CREATIVITY 7 Sui generis , bureaucratic and based on origin: a snapshot of the nature of EU Geographical Indications 130 Andrea Zappalaglio 8 The role of market-driven and legislative solutions to online music licensing in Europe 151 Guiseppe Mazziotti PART III INSTITUTIONS AND JUSTICE 9 Investor-state dispute settlement as a constraint on intellectual property lawmaking 178 Rochelle Cooper Dreyfuss Index

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Book SynopsisThis comprehensive book examines the judicial governance of the patent system in Europe and beyond, and looks at mechanisms for enhancing coherence. Federica Baldan investigates the challenges to judicial coherence which may arise after the establishment of a specialised patent court in Europe. The book highlights the various options that have been explored in the past decades for the creation of a centralised and specialised European patent court. Chapters retrace the most developed proposals for the establishment of a patent court, assess their impact on judicial coherence and identify potential weaknesses and room for improvement. The UPC Agreement has a central role in this analysis as it is the most advanced proposal and is currently in its implementation phase.Providing a comparative analysis of the US and Japanese patent systems and identifying the potential for improvements, this timely book will be a valuable resource for scholars, students and policymakers in the fields of IP law, governance and political science.Table of ContentsContents: Foreword 1. Introduction to Judicial Coherence in the European Patent System 2. Judicial coherence in patent systems: A conceptual framework 3. Judicial coherence in the current European patent system 4. The proposals for a specialised patent court in Europe and the challenges to judicial coherence 5. Judicial coherence in the US and Japanese patent systems 6. Mechanisms to foster judicial coherence in the future European patent system 7. Conclusion to Judicial Coherence in the European Patent System References Index

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Book SynopsisConcise yet comprehensive, this book provides an eloquent overview of the international patent system, outlining the requirements for protecting inventions and enforcing patent rights. It explores the mechanisms that ensure compliance in relation to these obligations and how they have been interpreted by international bodies.

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Book SynopsisConcise yet comprehensive, this book provides an eloquent overview of the international patent system, outlining the requirements for protecting inventions and enforcing patent rights. It explores the mechanisms that ensure compliance in relation to these obligations and how they have been interpreted by international bodies.

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Book SynopsisThis forward-looking book examines the issue of intellectual property (IP) law reform, considering both the reform of primary IP rights, and the impact of secondary rights on such reforms. It reflects on the distinction between primary and secondary rights, offering new international perspectives on IP reform, and exploring both the intended and unintended consequences of changing primary rights or adding secondary rights.Featuring contributions from leading scholars from across the globe, the book focuses on four main themes, beginning with an examination of reforms to fundamental aspects of IP. Part II explores the emergence of artificial intelligence and the data on which it relies, offering timely new thinking on the impact of this significant new aspect of IP. Chapters then discuss specific ideas for reform in relation to copyright and trademarks in Part III, and in respect of geographical names and indications in Part IV. This book will prove crucial reading for scholars and researchers of intellectual property, particularly those working on reform and the effects of technology. It will also be useful for policymakers seeking to understand the potential impacts of new policies and legislation.Trade Review‘As the book title suggests, The Future of Intellectual Property, contains several valuable contributions from scholars who seek to challenge the status quo or highlight certain deficiencies of the IP system. This collection of essays provides a valuable contribution to what will be a continuing debate between primary IP rights (copyright, trade marks, design and patent law) and the role of secondary rights (such as TPMs and RMI).’ -- Tyrone Berger, Intellectual Property Forum‘Each of the volume’s sixteen chapters adds an important dimension to topical matters and, collectively, they have presented a thorough consideration of the future of IP with global and national relevance.’ -- Caroline B Ncube, South African Law Journal‘Professor Gervais is to be congratulated on having brought together an exciting group of scholars who set out a range of bold and imaginative visions for the future of IP.’ -- Robert Burrell, University of Oxford, UKTable of ContentsContents: 1 Introduction to the future of intellectual property 1 Daniel J. Gervais PART I RETHINKING FUNDAMENTALS 2 Intellectual property for humanity: A manifesto 9 Phoebe Li 3 Intellectual property primary and secondary rights in international law: The case of Mexican Pharmaceutical Patents and the USMCA 37 Roberto Garza Barbosa 4 Company classification taxonomy and corporate intellectual property rights owners 55 Janice Denoncourt 5 Defining intellectual property as an investment 80 Emmanuel Kolawole Oke 6 Rights to do, rights to prevent, and an intersected approach? Lessons from intellectual property, information control and oil and gas 104 Abbe E.L. Brown PART II ARTIFICIAL INTELLIGENCE AND DATA 7 AI patents and the self-assembling machine 128 Dan L. Burk 8 Challenges of artificial intelligence to patent law and copyright law and countermeasures 149 Xiang Yu, Runzhe Zhang, Ben Zhang and Hua Wang 9 Is protection of data through data exclusivity, technological protection measures or rights management information actually intellectual property? 168 Margaret Ann Wilkinson 10 The doctrine of sound prediction – a possible tool to support patenting black box algorithms for personalized medicine? 191 Helen Yu PART III RETHINKING COPYRIGHT AND TRADEMARK LAW 11 A data-driven approach to copyright in the age of online platforms 207 Giuseppe Mazziotti 12 The CJEU and the educational exception in Renckhoff : Permitted to view but not to share? 229 Bukola Faturoti 13 Hyperlinking to copyright works in EU: Finding a weak link 251 Ivana Kunda 14 Modernization of trademark legislation in Mexico: The case of olfactory and sound marks 272 Guillermo Martínez Cons PART IV RETHINKING GEOGRAPHICAL NAMES AND INDICATIONS 15 Rebreeding geographical indications beyond agriculture: of ‘genotype’ and ‘phenotype’ in territorial products 273 Bernardo Calabrese 16 Brand new IP: ‘country name designation’ – from France with love 291 Natalie G. S. Corthésy Index

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Book SynopsisThis innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.After laying out the essential biotechnological innovations of the last 40 years, the authors conduct an in-depth analysis of European exclusive rights relating to biotechnology and healthcare, with particular attention to five key European jurisdictions - France, Germany, Italy, Poland and the UK. Delving into complex legal and ethical disputes over the rights to privacy, integrity, autonomy, health and science, the book argues for a more balanced patent system, protecting both human rights and intellectual property.This book will be a thought-provoking read for legal scholars, practitioners and policy-makers in the fields of biotechnology, pharmaceutical law, human rights law and intellectual property law. With its in-depth discussion of cutting-edge advances in biotechnology and the laws related to it, it will also prove enlightening for scholars and students interested in engaging with the field for the first time.Trade Review‘This book is thoughtful and well-written. It raises crucial legal, ethical, and moral questions that humanity will need to ask itself with the continuing advancements in medicine, artificial intelligence, pandemic preparedness, and patents. In short, this is a serious and even must-read for any scientific academic and practitioner in this area, as well as any competent lawyer or civil servant seeking to regulate and understand the different and competing interests.’ -- Isaac Maka, Legal Issues Journal‘This well-researched and informative book provides a unique insight into the complex intersections of biotechnology, patents and human rights in Europe. The authors distil the issues from a complicated web of laws and policies. Researchers and policy-makers should read this book to both understand how the law works and also how it might be improved.’ -- Susy Frankel, University of Wellington, New Zealand‘Patents in the field of biotechnological innovations as well as their enforcement have always triggered important tensions with a broad variety of human rights, in particular the right to health, human dignity, and the right to science. This very timely book explores these interactions, using an international, European and comparative law approach and offers a very stimulating analysis of the multiple legal and moral aspects of the topic, laying the foundation for an ethical approach to patent law in the future in the field of biotechnology.’ -- Christophe Geiger, Luiss Guido Carli University, Italy‘Focusing on the sphere of biotechnology, this book commands the attention of both the legal and scientific communities. For lawyers, it provides a detailed background on recently-developed medical technologies and discusses their impact on personal integrity and health care. For scientists, it explains the nature of the exclusive rights that national laws create to encourage investment in biotechnological innovation. For both communities, the book then provides a thoughtful discussion of approaches to balancing the interests of right holders against the human rights to health and to the benefits of science. Biotechnology is not the only sphere where intellectual property and human rights clash; the analysis provided here will be invaluable when other emerging problems, including climate change, pollution, and food security, arise.’ -- Rochelle Dreyfuss, New York University, School of Law, USTable of ContentsContents: An introduction to the current discussion about biotechnology, patents and human rights 1. What is being patented? An inquiry into recent developments in life sciences through the lens of patents 2. The patentability of inventions relating to the human body: non-technical exclusions to patentability and their normative basis 3. Patents for inventions concerning biological material contained in the human body in the light of human rights 4. Protection of health care innovation versus the rights to health and science 5. Challenges of IP for ground-breaking biotechnological innovation 6. Human rights of inventors and patentees versus rules of patent protection Index

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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 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 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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a huge range and FREE tracked UK delivery on ALL orders.

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a huge range and FREE tracked UK delivery on ALL orders.

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a huge range and FREE tracked UK delivery on ALL orders.

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a huge range and FREE tracked UK delivery on ALL orders.

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a huge range and FREE tracked UK delivery on ALL orders.

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a huge range and FREE tracked UK delivery on ALL orders.

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Book SynopsisBridges the gap between the realistic needs and questions of scientists and engineers and the legal skills of professionals in the patent field at a level accessible to those with no legal training Written for inventors in lay terms that they can relate to or easily follow Lays out the new features of patent law introduced by the America Invents Act of 2012 Explains the differences between the first-to-invent and first-to-file rules and why the two rules will coexist Focuses on the growth of new technologies in industry versus the laws protecting themTrade Review“Overall it represents a distillation of a very wide experience gained from many years of hands-on practice. This is a must-have buy for research establishments that do not have an in-house patent department.” (Chromatographia, 20 March 2015)Table of ContentsList of Figures ix List of Tables xi Preface xiii Introduction xvii About the Author xix 1. The First-to-File Rule: Evolution and Application 1 1.1 History of the First-to-File Rule in the United States 2 1.2 “Who’s on First?”: The Rule and Its Application 5 1.3 Adapting Business Routines to the First-to-File Rule 7 2. Prior Art before and after the AIA: Two Standards Compared 9 2.1 Prior Art and the First-to-File Rule 9 2.2 “But is It Art?”: The Art of Prior Art 10 2.3 And is It “Prior”?: Pre-AIA Law vs. the AIA 11 2.3.1 U.S. Patents and Published U.S. Patent Applications 11 2.3.2 Patents and Patent Applications Other than those of the United States 14 2.3.3 Other Published Literature 16 2.3.4 Commercial Activities 17 2.3.5 Otherwise Available to the Public 21 2.4 A Servant of Two Masters?: The “Effective Filing Date” and Its Role in Determining the Governing Rule 21 2.5 Conclusion 23 3. Creating One’s Own Prior Art: Self-Imposed Barriers to Patentability 25 3.1 The On-Sale Bar 26 3.1.1 Ready for Patenting? 26 3.1.2 Exceptions for Experimental Use 33 3.2 The Publication Bar: Publish and Perish? 35 3.2.1 Posting on an Internet Server 36 3.2.2 Slide Presentations and Posters at a Conference 37 3.2.3 Submission of a Thesis to a University Library 38 3.2.4 Grant Proposals 39 3.3 Observations 41 4. Canceling Prior Art and Other Benefits of Record Keeping 42 4.1 Derivation Proceedings 42 4.2 Disqualifying Reference Materials as Prior Art 45 4.3 Records Showing Collaboration 46 4.4 Records of Public Disclosures and Commercial Uses 48 4.5 Laboratory Notebooks 50 5. Inventing in an Employment Environment: The AIA’s New Recognition of Employer Interests and Project Management 52 5.1 Project Management and the New Definition of Prior Art 53 5.2 Allowing the Employer to Stand in for the Inventor 54 5.3 What Constitutes an Obligation to Assign? 56 5.4 Implying an Obligation to Assign When There is No Express Agreement 60 5.5 Having a “Sufficient Proprietary Interest” Other than by Assignment or Obligation to Assign 63 5.6 When No Assignment, Obligation to Assign, or Proprietary Interest: The “Shop Right” 63 6. The Novelty Threshold: Can You Recognize It When You See It? 67 6.1 Anticipation and the “All Elements in a Single Reference” Rule 68 6.1.1 “Incorporation by Reference” of the Missing Element from Another Source 70 6.1.2 Inherent Disclosure of the Missing Element 72 6.2 Novelty in the Arrangement of Parts 73 6.3 Another Argument Against Anticipation: The “Nonenabling Reference” 77 6.4 Caution: A Reference Can Anticipate an Invention Even if It “Teaches Away” from the Invention 79 6.5 Novelty versus Anticipation among Genus, Subgenus, and Species 84 6.5.1 Species Anticipating a Genus 84 6.5.2 Specific Value Anticipating a Range 85 6.5.3 “Shotgun” Disclosures in the Prior Art 85 6.5.4 Species or Subgenus Novel over a Larger, Encompassing Genus 86 6.5.5 Narrow Range Novel over a Broad Range Encompassing the Narrow Range 86 6.6 Are We Done? 87 7. Confronting the Prior Art: What Makes an Invention Nonobvious? 88 7.1 “But Every Invention is a Combination of Old Elements!” 90 7.1.1 Synergism and Changes in Function 90 7.1.2 “But Why Would a Munitions Manufacturer Go to a Horse Trainer (for the Missing Element)?” 92 7.1.3 “But Nobody Knew What the Problem Was (Before I Came Along)!” 94 7.1.4 “But They Said It Couldn’t Be Done!” 95 7.2 Pursuing the Unpredictable 99 7.2.1 Predictable Now but Unpredictable Then? 101 7.2.2 Finding a Needle in a Haystack 103 7.2.3 Unpredictability versus Optimization 105 7.3 In Hindsight (and Other Obvious or Nonobvious Thoughts) 107 8. The View from the Infringer’s Side: Challenging a Patent’s Validity 108 8.1 Do You Really Want to Go to Court? 109 8.2 Selecting Claims 111 8.3 Options for Challenge before the Patent is Granted 115 8.4 Options for Challenge after the Patent is Granted 118 8.4.1 Citation of Prior Art and Written Statements 118 8.4.2 Post-Grant Review and Inter Partes Review 119 9. Patent Eligibility: Pushing the Envelope on Subject Matter Appropriate for Patenting 122 9.1 Medical Diagnostic Methods 123 9.2 Computer-Implemented Processes 127 9.3 Business Methods 130 9.4 The AIA’s New Procedure for Challenging Business Method Patents 133 9.5 Conclusion: A Rule for Patent Eligibility? or a Case of “I’ll Know It When I See It”? 135 10. Selected Topics in Patent Strategy 139 10.1 Provisional Patent Applications 139 10.2 Strategies in Claim Construction 145 11. Patents and Beyond: The Variety and Scope of Intellectual Property 157 11.1 Trade Secrets 157 11.1.1 Scope 159 11.1.2 The Right of an Individual to Use Fundamental Skills 159 11.1.3 Comparing Trade Secrets to Patents 160 11.2 Trademarks 163 11.2.1 Choosing a Trademark 163 11.2.2 Securement, Maintenance, and Infringement of Trademark Rights 164 11.3 Copyrights 164 11.4 Design Patents 166 11.5 IP Coverage for Plants 167 11.6 Conclusion 167 Appendix A Selected Fees Charged by U.S. Patent and Trademark Office and Other U.S. Agencies for Intellectual Property as of January 1, 2014 170 Appendix B Patent Searchers 175 Acronym Glossary 178 Glossary 179 Bibliography, Websites, and Blogs 185 Patents and Published Patent Applications Cited 188 Cases Cited 191 Index 194

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