Patents law Books

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Book SynopsisIn this book, three experienced legal practitioners in patent matters provide a reliable and detailed guideline on how to enforce patents in three of the most important jurisdictions for patent infringement litigation, namely Germany, Japan and the United States. The book is structured by the relevant subject matters of patent litigation such as scope of patent protection, claims of the patent holder and objections of the alleged infringer, fact finding, pre-procedural measures, trial, principles of procedure and comparative aspects.

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Book SynopsisPaul England is Senior Counsel Knowledge at Taylor Wessing, UK.

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Book SynopsisThis handbook provides an expert overview of the law surrounding pharmaceutical, biological and chemical patents.The topic of chemical and biological patents is of special importance in European and German patent law. The highly technical nature of patents in this area gives rise to special problems for patent lawyers in understanding, for instance, structural alterations like polymorphism and enantiomerism, which lead to a derivative of a substance that is comprised in the prior art. It is a legal question whether and under what circumstances such alterations are treated as novel, and in which cases they are part of the state of the art. Even if a substance is prior art, a new medical use can be patented. Dealing with natural occurrences of a substance is also a problem for patent law, as is the difficulty of understanding how different identifications of a substance and the resulting patents interrelate with each other. This book provides an expert overview of all these questions. Past decisions of the European Court of Justice (ECJ) concerning broccoli and tomato patents, as well as embryonic stem cells, have highlighted the importance of this field of law. Most of the proceedings regarding chemical and biological patents have been held in German courts, and the German jurisprudence has often been the basis for ECJ decisions. Thus, German case law is used to illustrate the commentary.

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Book SynopsisAre innovation and creativity helped or hindered by our intellectual property laws? In the two hundred plus years since the Constitution enshrined protections for those who create and innovate, we're still debating the merits of IP laws and whether or not they actually work as intended. Artists, scientists, businesses, and the lawyers who serve them, as well as the Americans who benefit from their creations all still wonder: what facilitates innovation and creativity in our digital age? And what role, if any, do our intellectual property laws play in the growth of innovation and creativity in the United States? Incentivizing the progress of science and the useful arts has been the goal of intellectual property law since our constitutional beginnings. The Eureka Myth cuts through the current debates and goes straight to the source: the artists and innovators themselves. Silbey makes sense of the intersections between intellectual property law and creative and innovative activity by centTrade Review"Ultimately, The Eureka Myth does truly 'chart new terrain for our understanding of . . . scientific and artistic innovation and the intellectual property that purports to sustain them' (pp.5–6). Silbey offers unique insights into the work and motivations of creators and innovators and makes an original and thoughtful contribution to the discourse on intellectual property rights. The Eureka Myth would be a good addition to an academic law library collection, and it is a worthwhile read for anyone interested in intellectual law and policy."—Morgan M. Stoddard, Law Library Journal"The purpose of intellectual property laws is to promote the 'progress of science and useful arts' by securing property rights for authors and creators . . . Silbey articulates a compelling challenge to the incentive argument . . . A compelling counter to common assumption about IP law, backed by interesting anecdotal evidence, that will interest IP law scholars and practitioners . . . Recommended."—C. Fruin, CHOICE"The Eureka Myth substantially advances our understanding of why and how artists, scientists, businesses, and the lawyers who serve them use intellectual property as part of broader strategies, and how both economic and moral claims about creativity and IP match—and mismatch—with the formal law."—Rebecca Tushnet, Georgetown University Law Center"The Eureka Myth enriches our empirical understanding of the roles that intellectual property laws play in the lives of individual creators in scientific, and more literary and artistic fields. This provocative book explains why creators sometimes under-enforce their rights, and contrary to the common assumptions of IP specialists, it shows that individual creators rarely think of intellectual property rights as an inducement to be creative."—Pamela Samuelson, Berkeley Law School"The relationship between intellectual property law and human creativity is too often assumed rather than interrogated. By listening to creators, Silbey uncovers new and different reasons why people create and how intellectual property matters. This wise and luminous book is required reading for anyone who claims to understand IP law."—Julie E. Cohen, Georgetown University"At last—a book that provides the only sound basis for sound policy. Silbey did the hard work of asking those who create why they create and what they need to keep creating. In place of phony political bromides like 'I stand with artists,' we can finally hear what artists themselves say. We should listen."—Bill Patry, Senior Copyright Counsel, GoogleTable of ContentsContents and AbstractsIntroduction: Introduction chapter abstractThe introduction introduces the book as a qualitative empirical interview study with artists, scientists, engineers and business people in creative and innovative industries. It situates the book as an investigation into the motives and mechanisms of creative and innovative work and in the context of the theoretical and quantitative literature on IP and its success at achieving the "progress of science and the useful arts," a Constitutional goal. Based on analysis of the accounts from the interviews, the introduction describes how there exists a diversity of reasons for and mechanisms by which creative and innovative work gets made and distributed, only a small part of which is intellectual property law. This challenges core principles of IP law, especially an assumption that exclusivity through property rights is essential to stimulating art, science and technological progress. 1Inspired Beginnings chapter abstractChapter 1 traces the features of a specific story form, "the origin story" throughout the interviews. An "origin story" begins with an inspired moment that sets the person or organization on its path. Origin stories serves particular purposes. They explain how a culture or society began (e.g., Genesis). They infuse an aspect of everyday life with special significance by explaining why things are as they are (e.g., "you were born that way"). They guide how things should evolve in the future (e.g., "the agreement memorializes our future intentions"). Each interviewee explains a milestone in their professional life in terms of an origin story, referring to a past that has unique significance for making sense of the present. Chapter 1 canvasses these origin stories to explain how most describe the embarkation of their work in art or science mostly due to intrinsic or serendipitous forces, unrelated to IP. 2Daily Craft: Work Makes Work chapter abstractChapter 2 explores the varied ways the interviewees describe their daily work. Similarities in accounts coalesce around the dimensions of time, space and labor. Most articulate a common respect for constant and committed daily work, focusing on the importance of physical spaces (studio, lab, desk) and time spent. Distinct metaphors and word patterns illuminate the expressive focus on time, space and labor, highlighting a misfit between IP protection and the interviewees' aspirations or expectations for reward. Interviewees describe work with natural metaphors (e.g., harvesting or fishing), implying that the physical labor dignifies the output. This contrasts with IP, which does not reward labor or time. Interviewees translate their intellectual work into tangible output, comparing their work to real or personal property. Ironically, describing the value of their work in material terms strengthens the possessive impulse manifesting as property claims that are more robust than IP law provides. 3Making Do With A Mismatch chapter abstractChapter 3 describes the transitions from beginnings and everyday work to the business of developing a career in IP-rich fields. Interviewees provide diverse accounts of "making do" in creative and innovative industries. Although some interviewees describe direct reliance on specific forms of IP, many business models rely only indirectly on IP rights. Indeed, most interviewees embrace a system of IP that is "leaky" or misaligned insofar as IP is not the optimal avenue for achieving professional goals. Interviewees rarely describe the need to exercise the full range of exclusivity to which IP law entitles them. Although IP rights are both under-enforced and over-enforced at times, the most common strategy interviewees describe is to relax IP rights in order to achieve three common goals: a sustainable business, productive and satisfying relationships, and a measure of autonomy in life and work. 4Reputation chapter abstractChapter 4 describes how interviewees value reputation and attribution. When asked to describe some of the most contentious infractions during their career, interviewees describe reputational free riding, not economic free riding. And where the two intersect (which is often, especially in the trademark context), language of dignity and desert rather than economic harm dominates. Moreover, interviewees assert a desire for reputational control from IP law where it rarely exists. This Chapter analyzes the common accounts and metaphors that predominate in stories of reputational injury – stories of family, bodily integrity and life or death. Understandably, emotions run high in this context and the language seeking to justify the entitlement to reputational control often resemble stronger rights and obligations than IP (or neighboring regimes) provide. Over-protection in these situations can lead to misuse of IP laws or an increasing frustration from artists and scientists that IP law is irrelevant to them. 5Instruction: How Lawyers Harvest IP chapter abstractChapter Five describes how IP intervenes as an external force shaping and directing art and science. IP law affecting the work's on-going vitality is largely absent until a lawyer or business partner intervenes. IP arrives later for creative and innovative work trajectory and comes with a coach. Interviewees describe lawyers as disruptive and distracting, whereas the lawyer describes herself as bringing tools to facilitate work or business. When the lawyer is welcome, it is when she has translated IP into client interests resonating with everyday work or goals. The lawyer's varied characterizations of IP in terms the client accepts correlates to jurisprudential categories of legality (e.g., natural law, distributive justice). This invites the conclusion that IP's form and purpose, shaped by legal advice and client concerns, is not predetermined by legal rules or economic principles, but is constitutive of creativity and innovation and influenced by preexisting interests and motivations. 6Distribution: How IP Circulates chapter abstractDissemination is the ultimate goal of IP and a dominant reason interviewees pursue their work. Interviewees describe managing formal and informal agreements outlining the nature and scope of distribution. These agreements vary, from free and promiscuous sharing to circumscribed and discriminating price schemes. The propertization of the work (protecting it through exclusivity) is sometimes a precondition to fulfilling distribution goals, which include: earning a living, building relationships, sustaining professional autonomy and challenging core competencies. But interviewees describe how relaxed distribution networks satisfy most personal and professional goals. Indeed, strictly controlling dissemination – what IP law provides – is only one distributional method and not the most common. This chapter analyzes the interviews for accounts of the many forms dissemination takes and the reasons for engaging in it, unpacking the relationships between exclusive rights to distribution on the one hand and dissemination as a form of professional and personal success on the other. Conclusion: Conclusion chapter abstractThe book closes with a summary of how U.S. intellectual property regimes are misaligned with the needs of and hopes for those engaging in creative and inventive work. It further suggests reasons for and ways that the IP system should remain misaligned: to promote choice and flexibility for creators and innovators (whether or not they own or claim IP rights). But the conclusion also suggests places in our IP system where some relaxation of our IP system might usefully occur in order to facilitate core concerns of IP-rich fields and their audience as accounted for in the interview data.

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Book SynopsisThis unique book provides a comprehensive account of the patent misuse doctrine and its relationship with antitrust law. In addition to in-depth doctrinal and policy perspectives, it looks at patent misuse through the eyes of today’s leading practitioners, judges, government officials and academics.Trade ReviewThis is a long overdue book on the evolution of the US doctrine of patent misuse and its relationship with antitrust law. --Steven Anderman, Queen Mary Journal of Intellectual PropertyPatent Misuse and Antitrust Law in an excellent analysis of an understudied area of law bound to become increasingly important as watershed controversies and reforms continue to buffet patent law. --Shannon L. Malcolm, Law Library JournalOne of the most detailed and insightful analyses of the important, but maddeningly vague, doctrine of patent misuse and its relationship to antitrust law… Professor Lim tackles this complicated topic in an innovative and effective way. In addition to thoughtful legal, economic, and policy analysis, he uses a comprehensive empirical survey and coding of all patent misuse cases through the end of 2012 and substantial qualitative empirical research through interviews with practitioners and judges about the perceived, and actual, metes and bounds of this slippery doctrine. He thus throws valuable light on the state of the conventional wisdom as well as when and how actual practice and case law departs from that conventional wisdom --Spencer Weber Waller, World Competition Law and Economics ReviewTable of ContentsContents: Foreword by William E. Kovacic Preface Prologue Introduction 1. Misuse and Antitrust 2. A Brief History of Patent Misuse 3. The Anatomy of a Defense 4. Key Objections 5. Rethinking the Future of Patent Misuse 6. The Empirical Landscape of Misuse 7. Charting the Scope of Patent Misuse 8. Conclusion Index

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Book SynopsisConsidering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination.Trade Review'In sum, the book is well written, interesting and very topical. It is written by very knowledgeable lawyers, which is reflected in the high quality of the articles. . . I recommend this book, not only for academics but for practicing lawyers as well. Many of the contributions contain valuable ''take home messages'', which should be taken into account in the discussions.' --Marcus Norrgard, International Review of Intellectual Property and Competition Law'This is an intriguing selection of topical essays addressing fundamental questions of pharmaceutical innovation. It is comprised of a high-profile list of contributors, including academics, judges and practitioners from the U.S., Europe and Japan, who ''explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicines and health care''. . . This is an enjoyable, readable and interesting book containing thorough studies of ''hot'' legal issues in the pharma sector converging in an decisive era for pharmaceutical innovation. It ought to be found in any library that has reserved space for pharma-, IP- or competition law-related literature.' --Jur. Dr. Timo Minssen, European Competition Law Review Table of ContentsContents: Introduction Nari Lee and Josef Drexl PART I: PATENT PROTECTION FOR PHARMACEUTICAL METHODS 1. The Patentability of Genetic Diagnostics in US Law and Policy Rochelle C. Dreyfuss 2. Patentability of Pharmaceutical Innovations: The European Perspective Rainer Moufang 3. Patentability of Medical Methods in Japan Nari Lee PART II: DATA EXCLUSIVITY AND PATENT TERM EXTENSION: CONVERGENCE OR DIVERGENCE 4. Patent Term Restoration and Non-Patent Exclusivity in the US Margo A. Bagley 5. Clinical Data, Data Exclusivity and Private Investment Protection in Europe Christian R. Fackelmann 6. Patent Term Extension in Japan: An Academic and Comparative Perspective Ryoko Iseki 7. Recent UK Case Law on Supplementary Protection Certificates Richard Arnold 8. Patent Term Extension in Japan: Focusing on the Pacif Capsule Decision Toshiaki Imura PART III: BALANCING INCENTIVES AND COMPETITION IN EUROPE 9. Strategic Patenting by the Pharmaceutical Industry: Towards a Concept of Abusive Practices of Protection Hanns Ullrich 10. Anticompetitive Marketing in the Context of Pharmaceutical Switching in Europe Bengt Domeij 11. AstraZeneca and the EU Sector Inquiry: When Do Patent Filings Violate Competition Law? Josef Drexl Index

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Book SynopsisThis empirical study uses a scientifically selected sample of patents to assess patent quality. The careful evaluation of the assumptions in alternative economic theories about the generation and diffusion of new knowledge demonstrates that the height of the inventive step is critical to effective and efficient patent policy.Trade Review‘Just how inventive are inventions? More to the point, just how inventive are the inventions covered by patents? Not very, according to Hazel Moir, and there is no reason to doubt her conclusions. She has spent years in painstakingly analysis of dozens of business method patents in Australia and elsewhere. She finds. . . [t]hey are no more than strategic devices intended to annoy and disrupt commercial competition and confuse the market. . . Hazel Moir is a patent expert beholden to no patent theory and no patent interests. In consequence, her research is fresh and inspired. Her conclusion – that patents describe and protect obvious combinations of old ideas and trivial variations – may not be confined to business methods. It is a conclusion that demands the consideration of policymakers.’ -- Stuart Macdonald, Aalto University, Helsinki, Finland‘This book presents a compelling attack on the patent system. Thoughtfully analyzing the existing empirical literature and providing her own painstaking study of business method patents, Hazel Moir explains how it is that. . . patents have spread geographically and technologically, with increasingly broad rights becoming ever-easier to obtain. Bravely and persuasively, she recommends policymakers tackle one of the most vexing issues in patent law: the quantum of new knowledge that ought to be required to make an invention worthy of protection.’ -- Rochelle Dreyfuss, New York University, School of Law, US‘Hazel Moir’s book deserves to become a classic. Between its covers one will find writing of great clarity and data that reveal the real world costs of the patent system. After reading Moir’s analysis, one wonders what the actual social benefits of the patent system might be. This is evidence-based analysis at its best.’ -- Peter Drahos, Australian National University and Queen Mary, University of London, UK‘This book presents a compelling attack on the patent system. Thoughtfully analyzing the existing empirical literature and providing her own painstaking study of business method patents, Hazel Moir explains how it is that, despite the intuitions of economists, social scientists, lawyers, judges, and even some inventors, patents have spread geographically and technologically, with increasingly broad rights becoming ever-easier to obtain. Bravely and persuasively, she recommends policymakers tackle one of the most vexing issues in patent law: the quantum of new knowledge that ought to be required to make an invention worthy of protection.’ -- Rochelle Dreyfuss, New York University School of Law, USTable of ContentsContents: Preface 1. Introduction 2. The Economics of Patent Policy: Assumptions, Paradoxes and Evidence 3. Who Determines Patent Policy: Judges, Lobbyists or Legislatures? 4. In the National Interest: Defining Patentable Inventions 5. Finding and Avoiding Existing Knowledge 6. Combining Known Elements 7. The Quantum of Inventiveness: Other Approaches and Rules 8. Rebalancing the Patent System Appendix. Original Claims: Selected Patents References Index

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Book SynopsisTrade Review‘The proposal for the SPC system (rather than simple patent term extension) referred to “the simplicity of the system” and called what was proposed “balanced simple transparent.” None of that proved true and, in my opinion at least, was obviously wrong at the time. Dr Roussou traces its complex history with battles between research based and generic pharma brilliantly. She valiantly attempts the impossible task of not just describing but also explaining the tortured reasoning of the CJEU on a flood of cases – which to some, me included, suggests the Court has no proper understanding of patent law (what is a “protected product”) nor regulatory law (very narrow and precise). She tackles the fuzzy interaction with competition law, the policy implications for pharma research, what’s to be done about the UPC and SPCs and where the system should go next. Not everyone will agree with her (I don’t on a number of points), but all will agree she has produced a valuable and provocative book.’ -- Sir Robin Jacob, University College London, UKTable of ContentsContents: 1. Supplementary protection certificates for medicinal products: an introduction 2. The long road to the enactment of the SPC Regulation 3. Legal analysis of the SPC Regulation (i): the meaning of the term “protected by a basic patent” under Art. 3 (a) SPC Regulation 4. Legal analysis of the SPC Regulation (ii): the meaning of the term “product” in the light of Art. 1 (b) and 3 (d) of the SPC Regulation 5. Interaction between the SPC Regulation and the unified patent system 6. The application of competition law in cases of supplementary patent protection 7. The future of SPC regulation Bibliography Index

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Book SynopsisTrade Review‘In this volume he edited as ATRIP’s President, Jens Schovsbo turns the analytical spotlight on a key aspect of intellectual property rights, their exploitation, often via licenses and other contractual arrangements. The book offers useful ideas to improve the balance between IP owners and users, and those in between.’ -- Daniel Gervais, Vanderbilt University, USTable of ContentsContents: The exploitation of intellectual property rights: An overview 1 Jens Schovsbo 1 Regulating online content moderation: Taking stock and moving ahead with procedural justice and due process rights 5 Orit Fischman-Afori 2 Transparency of algorithmic decision-making: Limits posed by IPRs and trade secrets 28 Olga Kokoulina 3 Rebalancing intellectual property rights: A reflection on Australian IPRs, consumer and environmental rights 57 Leanne Wiseman and Kanchana Kariyawasam 4 Use requirements of patent laws during pandemic – ‘litmus test’? 83 Manchikanti Padmavati 5 Access to undisclosed know-how 112 Joy Y. Xiang 6 Sampling the ‘soul of music’ in a post-Pelham world: An interdisciplinary perspective 137 Kalpana Tyagi 7 Copyright reversion: Debates, data, and directions 161 Joshua Yuvaraj 8 Remunerating authors and performers: Are statutory fair compensation provisions sufficient? 187 Irina Eidsvold-Tøien 9 Limiting freedom of contract: Next step for copyright treaties? 216 David Felipe Alvarez-Amezquita and Florelia Vallejo-Trujillo Index

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Book SynopsisTrade Review‘If the COVID pandemic had a silver lining, it’s that it led us to reconsider exclusive rights as the principal mechanism for encouraging innovation. This book is a brilliant contribution to that analysis. In its pages, scholars from around the globe discuss flexibilities in the current IP regime and offer new approaches, both inside and outside that system, to improve access.’ -- Rochelle Dreyfuss, New York University School of Law, USTable of ContentsContents: IPR in times of crisis – lessons learned from the Covid-19 pandemic: An introduction xi Jens Schovsbo 1 The COVID-19 TRIPS waiver and the WTO Ministerial Decision 1 Peter K. Yu 2 Two decades after Doha: Compulsory licence and the Waiver Proposal under the COVID-19 pandemic 26 Cindy Zheng and Angelia Jia Wang 3 Unblocking the human right to access the benefits of science in the Covid-19 era 59 Genevieve Wilkinson and Evana Wright 4 Proactively ensuring access to essential medical solutions: Lessons learned from the COVID-19 pandemic 83 Helen Yu 5 Patent pools: A licensing option for medicines and vaccines in times of a crisis? 104 Agnieszka Sztoldman 6 Adequate remuneration for Crown use of patents: Some guidance from constitutional property law 122 Mikhalien du Bois 7 Copyright and COVID 140 Sean M. Flynn 8 Do we need another copyright or another science? (Re) interpreting the right to science for scholarly publishing 153 Klaus D. Beiter 9 An international instrument on copyright and educational uses: Regulatory models and lessons 182 Faith Majekolagbe and Giulia Priora 10 Revitalising the UK music industries in the aftermath of Covid-19: A feminist critique of music copyright 204 Metka Potočnik

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Book SynopsisA practical resource for valuing patents that is accessible to the complete spectrum of decision makers in the patent process In today''s economy, patents tend to be the most important of the intellectual property (IP) assets. It is often the ability to create, manage, defend, and extract value from patents that can distinguish competitive success and significant wealth creation from competitive failure and economic waste. Patent Valuation enhances the utility and value of patents by providing IP managers, IP creators, attorneys, and government officials with a useable resource that allows them to use actual or implied valuations when making patent-related decisions. Involves a combination of techniques for describing patent valuation Includes descriptions of various topics, illustrative cases, step-by-step valuation techniques, user-friendly procedures and checklists, and examples Serves as a useable resource that allows IP managers to Table of ContentsPreface ix Acknowledgments xiii Part One Foundations for Patent Valuation and Decision Making 1 Chapter 1 Valuation Basics 3 What Is Value? 5 The Valuation Process 7 Identifying the Subject Matter of the Valuation 9 Valuation Misconceptions 12 The Three Basic Valuation Methodologies 16 Limitations on Rationality in Valuation and Decision-Making Exercises 20 References 20 Notes 21 Chapter 2 Patent Basics 23 What Is a Patent? 26 Anatomy of a Patent 32 Criteria for a Patent 33 Transferring Patent Rights 36 Nationality of a Patent 39 References 40 Notes 40 Chapter 3 Using Valuation Analysis to Improve Patent Decision Making 43 Patent Decisions 45 Maximizing, Optimizing, and Satisficing: How Much to Invest in Valuation Analysis 52 Preliminary Portfolio Valuation Audit: A Practical Valuation Technique 58 References 65 Notes 65 Chapter 4 Disassembly 67 Disassembly and Decision Trees 69 Using Disassembly to Develop Higher-Quality Data 75 Using Disassembly to Understand Data Better 84 References 86 Notes 87 Part Two Patent Valuation Techniques 89 Chapter 5 Preparing for the Valuation 91 Understanding the Bundle of Legal Rights 91 Ownership Interest in the Patent 93 Description of the Patent Rights 99 Encumbrances on the Patent Rights 100 Understanding the Patent Rights’ Neighborhood 102 Exploiting the Patent Rights 103 References 117 Notes 119 Chapter 6 Income Methods: Discounted Future Economic Benefits Analysis 121 Basic Arithmetic of the Discounted Future Economic Benefits Analysis 124 Garbage In, Garbage Out: The Challenges Lay in the Inputs, Not the Math 131 Projecting Future Net Economic Benefits 133 Developing Projections from Analytical Analyses 143 Estimating the Discount Rate 151 References 159 Notes 160 Chapter 7 Advanced Income Methods: Incorporating the Value of Future Decision Opportunities 161 Option Contracts and Their Value 164 Real Options 168 Valuing Patents Using Option-Pricing Insights 170 Using Decision Trees to Incorporate the Value of a Patent’s Future Decision Opportunities 174 References 185 Notes 186 Chapter 8 Market Methods 189 Markets and Patent Rights 191 Competitive Exchange 198 Comparable Transactions 205 Alternatives to the Core Market Methods 207 References 214 Notes 216 Chapter 9 Cost Methods 219 A Few Accounting Principles 220 Cost of Development: Questionable Valuation Tool 224 Cost of Reasonable Alternatives: Establishing a Maximum Price 227 References 230 Notes 231 Part 3 Patent Valuation in Practice 233 Chapter 10 Pricing Patent Licenses 235 Payment Structures 236 Determining the Price for a License 246 Less Formal Valuation Techniques for Setting Royalty Rates 248 References 264 Notes 265 Chapter 11 Patent Infringement Damages 269 U.S. Legal Framework for Calculating Damages in Patent Infringement Cases 271 Lost Profits 275 Reasonable Royalty 285 Additional Patent Damages Matters 297 Answering the Sue or Settle Question 299 References 306 Notes 307 Chapter 12 Unlocking the Potential Value within Patents 313 Keeping Pace with Economic Changes 316 Patents as Collateral for Secured Loans 317 Securitizing Patents 325 References 333 Notes 334 Chapter 13 Valuation in Patent-Based Tax-Planning Strategies 337 Examples of Patent-Based Tax-Reduction Strategies 339 Transfer Pricing 344 Determining Transfer Prices for Patent Rights 348 References 358 Notes 359 About the Authors 363 Index 365

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Book SynopsisJo Bac’s groundbreaking legal study asks why and how the United States legal system should grant legal personhood to artificial intelligence (AI). This new legal status of AI is visualized as a dependent person, and the AI dependent legal person would be determined by an inextricable connection between AI and a new type of corporate body, introduced here as “AI-Human Amalgamation” (AI-HA).Artificial Intelligence has been defined as one or more computer programs with an ability to create work that is unforeseen by humans. This includes AI capacity to generate unforeseen innovations, patentable inventions, and/or infringe the rights of other patent holders. At present, AI is an entity unrecognized by law. The fact that AI is neither a natural nor a legal person indicates that it cannot be considered the owner of rights or bearer of liabilities. This in turn creates tension both in society and legal systems because questions such as who should hold the rights of AI or be liable for autonomous acts of AI remain unanswered.This book dynamically argues that the AI dependent legal person and AI-HA are necessary to address these new challenges. The creativity and actions of AI and AI-HA would be distinct from those performed by human beings involved in the creation of this amalgamation, such as AI’s operators or programmers. As such, this structure would constitute an amalgamation based on human beings and AI cooperation (AI-HA). As a dependent legal person, AI would hold the patent rights to its own inventions, thus ensuring favorable conditions for the incentives of the U.S. patent system. In addition, the proposed legal framework with the use of legislative instruments could address any liability concerns arising from foreseen and unforeseen actions, omissions, and AI’s failure to act.

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Book SynopsisIn a rapidly changing world, the underlying philosophies, the rationale and the appropriateness of patent law have come under question. In this insightful collection, the authors undertake a careful examination of existing patent systems and their prospects for the future. Scholars and practitioners from Japan, the US, Europe, India, Brazil and China give detailed analyses of current and likely future problems with their respective systems, and outline possible responses to them.With detailed and extensive contributions, this book will greatly appeal to students, practitioners, policymakers and academics who are interested in the problems of current patent system in the world and their future.Contents: T.G. Agitha, G. Carmichael, S. Elahi, Y. Futoshi, N.S. Gopalakrishanan, K. Karachalios, J.P. Kesan, M.A. Lemley, C. McGinley, K. Motohashi, N. Nakayama, C. Neppel, Y. Omori, Z. Ping, B. Rutz, R. Shimanami, V. Yumy Mitsuuchi-KunisawaTrade Review‘. . . this book, with its copious footnoting and detailed index, provides an excellent research tool for anyone professionally involved in the implementation and designing of patents and specifically of patent systems.’ -- Phillip Taylor MBE and Elizabeth Taylor, The Barrister MagazineTable of ContentsContents: Foreword Nobuhiro Nakayama Preface: Patent System at the Crossroads Yoichi Omori Introduction Ryo Shimanami PART I: ESSENCE AND FUNCTIONS OF THE PATENT SYSTEM 1. Current Situation and Vision of the Patent System: From the Perspective of Jurisprudence Ryo Shimanami 2. Current Situation and Vision of the Patent System: From the Perspective of Economics Kazuyuki Motohashi 3. Ignoring Patents Mark A. Lemley PART II: TRILATERAL AREA AND THE FUTURE OF THEIR PATENT SYSTEMS 4. The Future of IP in Europe Clara Neppel, Berthold Rutz, Guy Carmichael, Konstantinos Karachalios, Shirin Elahi and Ciaran McGinley 5. Taking Stock and Looking Ahead: The Future of U.S. Patent Law Jay P. Kesan 6. Issues and Possible Solutions in Japan: Patent Filing Activities of Japanese Companies, Resulting Backlog Problem, and Possible Solutions Futoshi Yasuda PART III: DEVELOPING COUNTRIES AND THE FUTURE OF THEIR PATENT SYSTEMS 7. The Indian Patent System: The Road Ahead N.S. Gopalakrishanan and T.G. Agitha 8. The Brazilian Patent System: Challenges for the Future Viviane Yumy Mitsuuchi Kunisawa 9. Review and Perspective of the Chinese Patent System Zhang Ping Index

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Book SynopsisDaniel Cahoy and Lynda Oswald have brought together some of the country's most prominent patent scholars outside the legal discipline. From the Leahy-Smith America Invents Act to recent court cases from the Supreme Court and the Federal Circuit, this timely, informative and well-edited volume examines the latest changes in US patent law and their impact on business strategy. The book is a must-read for anybody who wants to learn more deeply about the ever-increasing role of patents in the business environment.'>- Peter K. Yu, Drake University Law School, USWithin the complex global economy, patents function as indispensable tools for fostering and protecting innovation. This fascinating volume offers a comprehensive perspective on the US patent system, detailing its many uses and outlining several critical legislative, administrative and judicial reforms that impact business strategy.The expert contributors to this book provide an overview of how the US patent system functions today and describe how recent changes affect firms and individual inventors. Topics discussed include the drivers of intellectual property policy; recent revisions to the patent application process in terms of the new first-to-file regime, inequitable conduct, and allowable subject matter; and changes to patent enforcement and infringement related to the Federal Circuit's special role and post-grant review. Contributors address recent legislation such as the 2011 America Invents Act, which enacted some of the most significant patent reforms in decades.This examination of the US patent system highlights some of the most important issues for business. It will serve as an important tool for both policymakers and business leaders, and will also interest students and professors of business and management studies, innovation studies and business law.Contributors: C. Aceves, T.L. Anenson, D.L. Baumer, R.C. Bird, D.R. Cahoy, W.M. Chumney, J. Gehman, D.M. Gitter, Z. Lei, G. Mark, S.J. Marsnik, D. Orozco, L.J. Oswald, R.B. Sawyers, R.E. ThomasTrade Review‘Daniel Cahoy and Lynda Oswald have brought together some of the country’s most prominent patent scholars outside the legal discipline. From the Leahy–Smith America Invents Act to recent court cases from the Supreme Court and the Federal Circuit, this timely, informative and well-edited volume examines the latest changes in US patent law and their impact on business strategy. The book is a must-read for anybody who wants to learn more deeply about the ever-increasing role of patents in the business environment.’ -- Peter K. Yu, Drake University, Law School, USTable of ContentsContents: Introduction PART I: INFLUENCES ON PATENT POLICY 1. Coalition Formation and Battles to Effect Intellectual Property Policy Change in the Age of ACTA, AIA and the SHIELD Act Robert E. Thomas and Cassandra Aceves 2. Administrative Patent Levers in the Software, Biotechnology and Clean Technology Industries David Orozco PART II: REVISIONS TO PATENT APPLICATION PROCESS 3. The America Invents Act, Patent Priority, and Supplemental Examination Robert C. Bird 4. Inequitable Conduct after Therasense and the America Invents Act T. Leigh Anenson and Gideon Mark 5. The Patenting of a Profession—Accounting in the Crosshairs Wade M. Chumney, David L. Baumer and Roby B. Sawyers PART III: CHANGES TO THE SCOPE OF ENFORCEMENT AND INFRINGEMENT 6. Unexpected Hazards of a Specialized Patent Court: Lessons from Joint Infringement Doctrine Lynda J. Oswald 7. The Transformation of Patents into Information Containment Tools Daniel R. Cahoy, Joel Gehman and Zhen Lei 8. Will the America Invents Act Post-grant Review Improve the Quality of Patents? A Comparison with the European Patent Office Opposition Susan J. Marsnik PART IV: EMERGENCE OF EXCLUSION SYSTEMS BEYOND PATENTS 9. Biopharmaceuticals under the Patient Protection and Affordable Care Act: Determining the Appropriate Market and Data Exclusivity Periods Donna M. Gitter Index

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Book SynopsisThe patent has emerged as a dominant force in 21st century economic policy. This book examines the impact of the BRICS and other emerging economies on the global patent framework and charts the phenomenal rise in the number of patents in some of these countries.Guided by three of the world's leading thinkers on patent law and development, a group of experts from around the world, including the BRICS and key developed country patent powers, examine critical issues raised by patent globalization. Is increasing use of the patent system in China, India, Brazil and other emerging markets part of a deeper change in world technological leadership? Do the established patent powers of Europe, Japan and the USA continue to lead regulatory development of patent systems or are new models being formed in emerging markets? What are the effects of patent globalization on regions like the Middle East, Africa and lower income areas of Asia? Through the answers to these questions, the reader is furnished with a rounded understanding of 21st century patent globalization and emerging market dynamics.This book will appeal to patent law specialists, as well as scholars interested in the intersection between patents, innovation and economic development. In particular, the in-depth analysis would also be useful for policy analysts within government or research institutes working on patent policy issues.Contributors include: F.M. Abbott, D. Borges Barbosa, C.M. Correa, P. Drahos, M. El Said, C. Fink, P. Gehl Sampath, K. Karachalios, R. Kher, J. Kuanpoth, A. Kudlinski, T. Payosova, P. Roffe, S.K. Sell, Y. Tamura, G. Van Overwalle, Y.A. Vawda, H. Zhang, W. ZhuangTable of ContentsContents: PART I Introduction 1. Emerging Markets and the World Patent Order: The Forces of Change Frederick M. Abbott, Carlos M. Correa and Peter Drahos PART II Context 2. Intellectual Property Activity Worldwide – Key Trends, Facts, and Figures Carsten Fink 3. The Geo-politics of the World Patent Order Susan K. Sell 4. Rethinking the Patent System from the Perspective of Economics Haiyang Zhang 5. Rethinking the Role of the Patent Office from the Perspective of Responsive Regulation Peter Drahos 6. The Technology Transfer Debates and the Role of Emerging Economies Padmashree Gehl Sampath and Pedro Roffe 7. Development Strategies of Emerging Economies in the Era of Climate Change: Do Patent Statistics Tell us Anything? Konstantinos Karachalios PART III The BRICS Brazil 8. Patents and the Emerging Markets of Latin America – Brazil Denis Borges Barbosa China 9. Evolution of the Patent System in China Wei Zhuang India 10. India in the World Patent Order Rajeev Kher Russia 11. Russian Trip to the TRIPS: Patent Protection, Innovation Promotion and Public Health Tetyana Payosova South Africa 12. Harmonizing the National Policies for Healthcare, Pharmaceutical Industry and Intellectual Property: The South African Experience Andre Kudlinski 13. Patent Law in Emerging Economies: South Africa Yousuf A. Vawda PART IV ASEAN 14. Patents and the Emerging Markets of Asia: ASEAN and Thailand Jakkrit Kuanpoth PART V The Middle East 15. IP Policy and Regulation in the Arab World: Changes, Challenges and Opportunities Mohammed El Said PART VI The OECD Response Europe 16. The Impact of Emerging Market Patent Systems on Europe: Awaiting “The Rape of Europa”? Geetrui Van Overwalle Japan 17. IP-Based Nation: Strategy of Japan Yoshiyuki Tamura USA 18. The United States Response to Emerging Technological Powers Frederick M. Abbott

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Book SynopsisThe patent has emerged as a dominant force in 21st century economic policy. This book examines the impact of the BRICS and other emerging economies on the global patent framework and charts the phenomenal rise in the number of patents in some of these countries.Guided by three of the world's leading thinkers on patent law and development, a group of experts from around the world, including the BRICS and key developed country patent powers, examine critical issues raised by patent globalization. Is increasing use of the patent system in China, India, Brazil and other emerging markets part of a deeper change in world technological leadership? Do the established patent powers of Europe, Japan and the USA continue to lead regulatory development of patent systems or are new models being formed in emerging markets? What are the effects of patent globalization on regions like the Middle East, Africa and lower income areas of Asia? Through the answers to these questions, the reader is furnished with a rounded understanding of 21st century patent globalization and emerging market dynamics.This book will appeal to patent law specialists, as well as scholars interested in the intersection between patents, innovation and economic development. In particular, the in-depth analysis would also be useful for policy analysts within government or research institutes working on patent policy issues.Contributors include: F.M. Abbott, D. Borges Barbosa, C.M. Correa, P. Drahos, M. El Said, C. Fink, P. Gehl Sampath, K. Karachalios, R. Kher, J. Kuanpoth, A. Kudlinski, T. Payosova, P. Roffe, S.K. Sell, Y. Tamura, G. Van Overwalle, Y.A. Vawda, H. Zhang, W. ZhuangTable of ContentsContents: PART I Introduction 1. Emerging Markets and the World Patent Order: The Forces of Change Frederick M. Abbott, Carlos M. Correa and Peter Drahos PART II Context 2. Intellectual Property Activity Worldwide – Key Trends, Facts, and Figures Carsten Fink 3. The Geo-politics of the World Patent Order Susan K. Sell 4. Rethinking the Patent System from the Perspective of Economics Haiyang Zhang 5. Rethinking the Role of the Patent Office from the Perspective of Responsive Regulation Peter Drahos 6. The Technology Transfer Debates and the Role of Emerging Economies Padmashree Gehl Sampath and Pedro Roffe 7. Development Strategies of Emerging Economies in the Era of Climate Change: Do Patent Statistics Tell us Anything? Konstantinos Karachalios PART III The BRICS Brazil 8. Patents and the Emerging Markets of Latin America – Brazil Denis Borges Barbosa China 9. Evolution of the Patent System in China Wei Zhuang India 10. India in the World Patent Order Rajeev Kher Russia 11. Russian Trip to the TRIPS: Patent Protection, Innovation Promotion and Public Health Tetyana Payosova South Africa 12. Harmonizing the National Policies for Healthcare, Pharmaceutical Industry and Intellectual Property: The South African Experience Andre Kudlinski 13. Patent Law in Emerging Economies: South Africa Yousuf A. Vawda PART IV ASEAN 14. Patents and the Emerging Markets of Asia: ASEAN and Thailand Jakkrit Kuanpoth PART V The Middle East 15. IP Policy and Regulation in the Arab World: Changes, Challenges and Opportunities Mohammed El Said PART VI The OECD Response Europe 16. The Impact of Emerging Market Patent Systems on Europe: Awaiting “The Rape of Europa”? Geetrui Van Overwalle Japan 17. IP-Based Nation: Strategy of Japan Yoshiyuki Tamura USA 18. The United States Response to Emerging Technological Powers Frederick M. Abbott

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Book SynopsisAurora Plomer explores international human rights, and its relevance to battles over intellectual property and science. Her work highlights the need for the benefits of scientific research to be fairly and equitably shared. Her work is an important original contribution to the literature on intellectual property, human rights, and the sociology of science.'- Matthew Rimmer, Queensland University of Technology, Australia'This remarkable book highlights and analyzes the inherent tensions and complementarities of patents with access to science, as materialized in the most prominent international human rights agreements. A must-read for anyone interested in one of the most crucial and debated questions of intellectual property, examined here from the perspective of its fascinating but complex interactions with human rights.'- Christophe Geiger, University of Strasbourg, France'The relationship between patents, human rights and science raises fundamental questions for innovation and for access to the benefits of scientific endeavour. Yet the complexities of the underlying science and legal environment in which it operates cannot be underestimated. Aurora Plomer deftly navigates this terrain with great clarity and skill. The resulting book is timely, accessible and a thorough scholarly work that demystifies and throws new light on the interface between science and the law.'- Duncan Matthews, Queen Mary University of London, UKThe new millennium has been described as 'the century of biology', but scientific progress and access to medicines has been marred by global disputes over ownership of the science by universities and private companies. This book examines the challenges posed by the modern patent system to the right of everyone to access the benefits of science in international law.Aurora Plomer retraces the genesis and evolution of the key Articles in the UN system (Article 27 UDHR and Article 15 ICESCR). She combines the historiography of these Articles with a novel perspective on the moral foundations of rights of access to science to draw out implications for today's controversies on patents in the life-sciences. The analysis suggests that access to science as a fundamental right requires both freedom from political and religious interference and the existence of enabling research institutions and educational facilities which promote the flow of knowledge through transparent and open structures. From this perspective, the global patent system is shown to fail spectacularly when it comes to the human rights ideal of universal access to science. The book concludes that a fundamental restructuring of patent institutions is required, in which democratic oversight of patent policies would ensure meaningful realization of the right of everyone to access the benefits of science.Students and scholars of international law, particularly those focusing on intellectual property and human rights, will find this book to be of considerable interest. It will also be of use to practitioners in the field.Trade Review‘Aurora Plomer explores international human rights, and its relevance to battles over intellectual property and science. Her work highlights the need for the benefits of scientific research to be fairly and equitably shared. Her work is an important original contribution to the literature on intellectual property, human rights, and the sociology of science.’ -- Matthew Rimmer, Queensland University of Technology, Australia‘This remarkable book highlights and analyzes the inherent tensions and complementarities of patents with access to science, as materialized in the most prominent international human rights agreements. A must-read for anyone interested in one of the most crucial and debated questions of intellectual property, examined here from the perspective of its fascinating but complex interactions with human rights.’ -- Christophe Geiger, University of Strasbourg, France‘In sum, Patents, Human Rights and Access to Science is an excellent book that scholars interested in the interplay of intellectual property, science and human rights should add to their reading list. Plomer is manifestly passionate about instituting significant reform in the global patent system to facilitate democratic oversight of patent policies and their compliance with human rights, and to ensure meaningful realisation of the right of everyone to access the benefits of science. Her argument is compelling. Let us hope that the international agencies created to defend universal human rights, as well committed individuals, patent offices, courts, non-governmental organisations and companies across the globe, work together to heed the sage advice offered in this book.’ -- SCRIPT-ed – the Online Law and Technology Journal‘This book offers an innovative and insightful reflection on the interplay between fundamental human rights and the intellectual property regime. It builds on Amartya Sen's theory of human capabilities in offering a fresh analysis of the the tension between the rights of inventors and the public interest in access to the benefits of science. The timeliness of this contribution is underscored by the growing scope of 'patentability' over genetic material and other life forms permitted by patent offices and superior courts in the United States and in Europe, as well as the entrenchment of corporate power at the expense of basic health needs through the extension and enforcement of intellectual property rights over essential medicines. Professor Plomer's argument for greater consideration of the public dimension is secured by her impressive archival study of the drafting history of the Article 27 Universal Declaration on Human Rights and Article 15 of the International Covenant on Economic, Social and Cultural Rights.’ -- John Harrington, Cardiff University, UK‘The relationship between patents, human rights and science raises fundamental questions for innovation and for access to the benefits of scientific endeavour. Yet the complexities of the underlying science and legal environment in which it operates cannot be underestimated. Aurora Plomer deftly navigates this terrain with great clarity and skill. The resulting book is timely, accessible and a thorough scholarly work that demystifies and throws new light on the interface between science and the law.’ -- Duncan Matthews, Queen Mary University of London, UK‘We are indebted, indeed, to Aurora Plomer for writing this book and for saying out loud and clearly the most important thing that needs to be said: we might be where we are, and it might not be the ideal place to be, but we should all – patent lawyers, scientists and citizens – take human rights seriously.’ -- Law, Innovation and TechnologyTable of ContentsContents: 1. Patents, Profits and the Public 2. The Moral Architecture of Human Rights and Rights of Access to Science 3. The Human Rights Paradox: Intellectual Property Rights and Rights of Access to Science 4. From Moral Ideals to Legal Obligations: The Genesis of Article 15 ICESCR 5. The UN’s Official Thinking on Article 15(1)(c) 6. UNESCO : Biotechnology, Bioethics and the Rights to Share in the Benefits of Science 7. Conclusion Index

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Book SynopsisDue to disagreement between policymakers and innovation economists, antitrust agencies have been rather confused over when and how to use competition law in reference to research and development (R&D) joint ventures and collaborations. This important book dissects the antitrust treatment, in the USA and under EU law, of joint R&D ventures from the 1970s to the present day. It provides a comprehensive analysis of the modifications and amendments made to legal acts and guidelines. It also looks at the slow shift in the scant case law detected both under the antitrust laws of the USA and the competition rules of the EU.Björn Lundqvist demonstrates that the prevailing antitrust policies towards R&D collaborations are very similar in the USA and the EU, and that they both mirror a lenient attitude towards collaboration between competitors. Nonetheless, ultimately, the book shows that a more stringent attitude from the antitrust establishment can be discerned, and that the concept of the innovation market could possibly soon have a revival.This fascinating book caters to both researchers and practitioners in competition law and economics. The easy-to-follow chart and boxes will be particularly useful for practitioners when setting up R&D joint ventures.Table of ContentsContents: 1. Introduction 2. Innovation Economics 3. Research and Development Agreements under US Antitrust Law and EC Competition Rules 4. Innovation Policy to be Implemented Index

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Book SynopsisWhat will European patent litigation look like in 10 years time? With the coming into force of seismic reforms, European Patent Litigation in the Shadow of the Unified Patent Court combines close analysis of the current regime with a novel use of qualitative survey data to assess the introduction of the Unified Patent Court (UPC) and the new European Patent with Unitary Effect. Not long ago only scant data were publicly available on the subject of patent litigation in EU member states. Using recently published data, Luke McDonagh paints a detailed picture of the patent litigation system in the key European jurisdictions of the UK, Germany, France and the Netherlands. He then outlines the rationale for reform - the perceived need to provide a more efficient, cost effective, harmonious litigation system - as well as the structure of the key reformative innovations. Making use of evidence from within the business and legal communities, this book highlights the key issues concerning the new system and examines what the impact of the reforms is likely to be on Europe's patent litigation system in the near future.This illuminating book will be useful to scholars, including postgraduate students, practitioners and policy makers wishing to learn more about the future of patent litigation in Europe.Trade Review'This distinguished book is to be highly recommended for its comprehensive coverage of and practical information on the impending European patent system. It is definitely indispensable for people concerned not only with Europe but also internationally, including, of course, with Asia.' --Tatsuhiro Ueno, Waseda University, Tokyo, Japan'Certainly the practical information and insightful commentary contained in this book will be appreciated by students, academics and policy makers, as well as practitioners.' --The BarristerTable of ContentsContents: 1. Introduction 2. European Patent Litigation Under the European Patent Convention (EPC) 3. Analysing the Reforms - The Unified Patent Court (UPC) and the European Patent With Unitary Effect (UP) 4. Exploring Perspectives of the Unified Patent Court and Unitary Patent Within the Business and Legal Communities 5. Conclusion Index

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Book SynopsisProfessor Stazi's volume on biotechnological inventions is an excellent work that any scholar or practitioner in this complex area of law should not only read, but also frequently consult. This detailed, systematic and comprehensive explanation of the provisions on 'patentability of life' - both in the EU and the USA - is combined with the related theories and constructions as well as the relevant case law. In this regard, the author offers a balanced overview of the relevant provisions and their explicit or implied exceptions.'- Alberto Musso, University of Bologna, Italy'The appropriate protection of biotechnological inventions and the so-called 'patentability of life' are one of the most crucial questions of modern intellectual property. It is also one of the most debated, as it involves not only complex legal issues but raises high social, ethical and even sometimes religious concerns. Professor Stazi's book is thus a very timely contribution, managing the 'tour de force' of combining serious and comparative doctrinal analysis of the criteria (and the limits) of patentability, while at the same time offering a good overview of the challenges with regard to bioethics and fundamental rights. Without any doubt, this volume will enrich the already excellent series on New Directions in Patent Law.'- Christophe Geiger, CEIPI, University of Strasbourg, FranceIn today's technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyzes the forms and limitations of patent protection recognition for biotechnological inventions, with particular regard to patentability of life.The author expertly compares the United States model, traditionally based on technical evaluations, with the European model, inspired by fundamental rights and bioethics. He highlights how the regulation of biotechnological inventions should guarantee a fair balance between protection of investment and access to information, which is essential for further research and innovation.Academics and practitioners dealing with intellectual property, patent law and biotechnological inventions will find this book to be of interest. The topics discussed will also be useful for patent offices and medical institutions, as well as medical researchers.Trade Review‘Professor Stazi’s volume on biotechnological inventions is an excellent work that any scholar or practitioner in this complex area of law should not only read, but also frequently consult. This detailed, systematic and comprehensive explanation of the provisions on “patentability of life” – both in the EU and the USA – is combined with the related theories and constructions as well as the relevant case law. In this regard, the author offers a balanced overview of the relevant provisions and their explicit or implied exceptions.’ -- Alberto Musso, University of Bologna, Italy‘The appropriate protection of biotechnological inventions and the so-called “patentability of life” are one of the most crucial questions of modern intellectual property. It is also one of the most debated, as it involves not only complex legal issues but raises high social, ethical and even sometimes religious concerns. Professor Stazi’s book is thus a very timely contribution, managing the “tour de force” of combining serious and comparative doctrinal analysis of the criteria (and the limits) of patentability, while at the same time offering a good overview of the challenges with regard to bioethics and fundamental rights. Without any doubt, this volume will enrich the already excellent series on New Directions in Patent Law.’ -- Christophe Geiger, CEIPI, University of Strasbourg, FranceTable of ContentsContents: 1. Patent Protection of Biotechnological Inventions and the Limits of Patentability 2. Interventions on Human Genetic Material: Legal and Bioethical Issues 3. The Evolution of the Discipline and Problematic Issues in the United States of America 4. The Evolution of the Discipline and Problematic Issues in Europe Conclusions Index

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Book SynopsisPatent holders are increasingly making voluntary, public commitments to limit the enforcement and other exploitation of their patents. The best-known form of patent pledge is the so-called FRAND commitment, in which a patent holder commits to license patents to manufacturers of standardized products on terms that are ''fair, reasonable and non-discriminatory.'' Patent pledges have also been appearing in fields well beyond technical standard-setting, including open source software, green technology and the biosciences. This book explores the motivations, legal characteristics and policy goals of these increasingly popular private ordering tools. Jorge Contreras and Meredith Jacob bring together work by more than a dozen international experts who examine the phenomenon of patent pledges from a variety of perspectives and analytical frameworks. The book assesses patent pledges as mechanisms for facilitating platform promotion, open innovation, economic development and environmental sustainability. Legal practitioners who are involved in intellectual property licensing, litigation and business transactions will find this book a key resource, as will in-house lawyers and managers at firms engaged in technology development and standardization. It will also be a key reference for scholars in law, economics, business and political science.Contributors include: C. Asay, B. Awad, M. Bohannon, M. Callahan, J. Contreras, D. Greenbaum, M. Jacob, Y. Kim, M. Maggiolino, C. Maracke, A. Metzger, L. Montagnani, J. Schultz, S. Scott, T. Sebastian, N. Shanahan, R. Sichel, R. Sikorski, T. Simcoe, D. Valz, L. Vertinsky, E. Wang, E. Winston, S.-S. YiTrade Review'Patent Pledges Global Perspectives on Patent Law’s Private Ordering Frontier, is a must-read for anyone involved in technology development and standardization. The authors analyze the complexity of patent pledges in a clear and concise manner. Moreover, even though the book is addressed to practitioners in the field of IP licensing, litigation, technology development, and standardization, the way in which the content is addressed makes the book useful as well for scholars in various fields.' -- IPkat blogTable of ContentsContents: Introduction Part I: Landscape of Patent Pledges 1. A Patent Pledge Taxonomy Jorge L. Contreras 2. Unilateral Patent Pledges - Motivations and Key Principles Duane R. Valz 3. Patent Sharing in Biotechnology Dov Greenbaum 4. Patent Pledges In Green Technology Bassem Awad Part II: Litigation Involving Patent Pledges 5. Patent Pledge Enforcement Theories Jorge L. Contreras 6. Patent Pledges at the U.S. International Trade Commission Elizabeth I. Winston 7. Voluntary Patent Pledges: Enforcement in Germany Catharina Maracke and Axel Metzger Part III: Competition Law and Patent Pledges Around the World 8. Is Patent Reform via Private Ordering Anticompetitive? An Analysis of Open Patent Agreements Matthew W. Callahan and Jason M. Schultz 9. Enforcing Patent Pledges Under EU Law Rafal Sikorski 10. Patent Pledges and Antitrust Law in Brazil Ricardo Sichel 11. Patent Pledge Enforcement in China Elizabeth Xiao-Ru Wang 12. Patent Pledges: Korean Perspectives Sang-Seung Yi and Yoonhee Kim Part IV: Patent Pledges and Innovation 13. The Informational Effects Of Patent Pledges Clark D. Asay 14. Open Innovation And Patent Pledges Mariateresa Maggiolino and Maria Lillà Montagnani 15. The Role of Patent Pledges in the Cloud Liza Vertinsky 16. Patent Pledges and Developing Countries: The Tryst with India’s Destiny Tania Sebastian Part V: Patent Pledges Moving Forward 17. How to Make and Keep a Patent Pledge Timothy S. Simcoe 18. A Registry for Patent Pledges Jorge L. Contreras 19. Overcoming Information Asymmetry in Patent Pledge Records Nicole Shanahan 20. Best Practices for Making Patent Pledges Meredith Jacob Index

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Book SynopsisThis significantly updated second edition of the Research Handbook on Patent Law and Theory provides comprehensive coverage of new research for patent protection in three major jurisdictions: the United States, Europe and Japan. Leading patent scholars and practitioners provide an innovative comparative analysis of fundamental issues such as patentability, examination procedure and the scope of patent protection, with current issues such as patent protection for industry standards, computer software and business methods. Updates to this second edition reflect on the dramatic changes that have taken place in the US Patent System since the first edition, including the American Invents Act that has introduced the first-inventor-to-file policy and post-issuance proceedings to challenge validity. Current topics such as the Unified Patent Court, patent litigation updates reform in the US, design patents and patent inventions in medical science are also addressed. Providing a strong scholarly foundation, as well as useful tips for practitioners to protect their intellectual assets in technologies effectively in the global market, this Research Handbook will be of great interest to legal scholars and students, as well as lawyers and patent attorneys.Contributors include: J.N. Adams, C. Appelt, R.C. Dreyfuss, H. Goddar, H.P. Göetting, O. Granstrand, S. Hetmank, C.M. Ho, C.M. Holman, C. Karl, J.B. Krauss, A.L. Landers, S. Luginbuehl, T. Miyamoto, T. Müller-Stoy, X.T. Nguyen, S. Ono, C. Rademacher, G. Reilly, S. Schohe, D. Stauder, T. Takenaka, J. ThomasTrade Review'The second edition brings the marvelous first edition up to date and adds a number of new and useful chapters. It is essential reading for student and practitioners of comparative patent law. Moreover, its comparative focus is illuminating for those who specialize in a single country's patent law by providing an enlarged perspective.' --Martin J. Adelman, George Washington University Law School, US'Professor Takenaka's Research Handbook on Patent Law and Theory is out in its second edition. It is a solid piece of work, sketching not only patent law's doctrinal bases, but also its practice. Highly recommended for patent attorneys, patent litigators, and policy makers alike!' --Christoph Ann, TUM School of Management, GermanyTable of ContentsContents: PART I FOUNDATION 1. History of the patent system John N. Adams 2. International treaties and patent law harmonization: today and beyond Tomoko Miyamoto 3. Patents and policies for innovations and entrepreneurship Ove Granstrand PART II EXAMINATION PROCEDURE 4. Trilateral cooperation – mutual exploitation of search and examination results among patent offices – has been evolving into Global Cooperation as in the case of IP5 Offices Shinjiro Ono 5. Patenting software-related inventions in Europe Stefan Schohe, Christian Appelt, and Heinz Goddar 6. Patenting inventions in medical sciences Jan B. Krauss 7. A comparative approach to the inventive step Amy L. Landers 8. The Lilly written description requirement: A doctrinal ‘wild card’ of uncertain effect Christopher M. Holman PART III PATENT ENFORCEMENT 9. Claim construction under U.S. and German patent acts: wording used in the claims and the invention disclosed in the specification Toshiko Takenaka and Christof Karl 10. The scope of patent protection for spare parts and its extension through other tools of intellectual property Horst Peter Götting and Sven Hetmank 11. Patent enforcement in Germany Tilman Müller-Stoy 12. The theory and practice of patent damages in Japan and the U.S. – explaining the differences that remain Christoph Rademacher 13. Resolving patent disputes in a global economy Rochelle Dreyfuss 14. Specialized IP courts: the Unified Patent Court (UPC) Stefan Luginbuehl and Dieter Stauder PART IV CURRENT ISSUES 15. Pharmaceutical patents John Thomas 16. Patent litigation reform in the United States Greg Reilly 17. Design patent—utility patent intersection Xuan Thao Nguyen 18. Current controversies concerning patent rights and public health in a world of international norms Cynthia Ho Index

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The patent system is criticized today by some practitioners and economists. In fact, there is a partial disconnection between patent demographics and productivity gains, but also the development of actors who do not innovate and who develop business models that their detractors equate with a capture of annuities or a dangerous commodification of patents. This book provides a less Manichaean view of the position of patents in the system of contemporary innovation. It first recalls that these criticisms are not new, before arguing that if these criticisms have been revived, it is because of a partial shift from an integrated innovation system to a much more fragmented and open system. This shift accompanied the promotion of a more competitive economy. The authors show that this movement is coherent with a more intensive use of patents, but also one that is more focused on their signal function than on their function of direct monetary incentive to innovation.

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Book SynopsisThis book constitutes a fascinating and in-depth analysis of the significance of the requirement of industrial application within gene patenting and how this influences innovation in Europe and the US. The author addresses an area normally overlooked in biotechnology patenting due to the predominance of the ethical debate and, in doing so, produces a unique approach to dealing with concerns in this field. Patenting Genes: The Requirement of Industrial Application is the result of extensive research into the legal history of the industrial application requirement as well as exploration of the broad range of decisions on DNA patentability. This requirement has taken a prominent role within DNA patenting decisions in Europe since the 1998 Biotech Directive, which Dr Diaz Pozo argues has worked efficiently to control claims to human gene sequences and encouraged progress in genetic research. A broad selection of decisions on the patentability of DNA in both European Union and US courts is discussed, emphasizing the mirroring of the European approach in US cases. Academics and students of patent law and biotechnology innovation, as well as policy formulators, will find this book of great interest and value. Activists and practitioners interested in the patentability of human gene inventions in Europe and the US will also benefit from this original work.Trade Review'This insightful and accessible book provides a uniquely thorough examination of the European requirement of industrial application and the determination of the scope of protection of gene patents. It is a scholarly work of the highest quality and rewards readers with its clear and accessible approach to the often overlooked legal issues surrounding the patentability of biotechnological inventions on grounds of industrial application. The book is highly recommended for academics and for practitioners alike.' --(Duncan Matthews, Queen Mary University of London, UK)'This book provides a valuable contribution to the understanding of industrial application in patent law. It shows how - with the evolvement of biotechnology patent law - a formerly obscure patentability requirement became a key tool for patent law policy. A detailed discussion of the Biotechnology Directive, as well as in-depth analysis of EPO and CJEU jurisprudence, makes this book worthwhile reading for any IP lawyer concerned with patent law.' --(Herbert Zech, University of Basel, Switzerland)Table of ContentsContents: 1. Introduction 2. Genetic inventions and patent law in Europe 3. The European requirement of industrial application 4. The industrial applicability of human genetic inventions 5. The requirement of industrial application and the interpretation of the exclusion of human genetic discoveries from patent protection 6. The requirement of industrial application and the determination of the scope of protection of gene patents 7. Human gene patents, patent clusters and innovative progress 8. Conclusion Index

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Book SynopsisThis ground-breaking and timely contribution to the field of Intellectual Property law explores the implications of 3D Printing and Additive Manufacturing in three core jurisdictions: the UK, USA and Australia. Providing in-depth analysis of the current state of affairs, as well as outlining future issues and developments, 3D Printing and Beyond addresses both the challenges and opportunities created by 3D Printing.Bringing together both academic and practical experts, the original contributions to this book consider the regulation of new, emerging and future technologies and their implications for the legal landscape. The book goes beyond 3D printing and its relationship with intellectual property to the realms of ethics, contracts, socio-legal aspects and economics. Intellectual property academics will greatly benefit from reading this book, as it not only explores the myriad ways in which 3D printing has altered the horizon of IP law, but also offers ideas for areas of future research. Practitioners and policy makers will also benefit from the useful examples and cases used in this book.Contributors include: T. Berger, S. Bradshaw, R. Brownsword, A. Daly, D. Desai, E. Ferrill, T. Holbrook, D. Hong, K. Horn, M. Lemley, R. MacKichan, T. Margoni, C. McKinley, D. Mendis, P. Menell, M. Mimler, D. Nicol, J. Nielsen, M. Rimmer, A. Scardamaglia, R. VaccaTrade Review3D Printing and Beyond is a thoroughly considered and impressive exposition of US, UK, and Australian IP law in the context of 3D printing. The distinguished group of authors, all of whom are thought leaders on the issues of 3D printing and IP, explore the law as it exists and perceived gaps, potential market responses to 3D printing-driven democratization of manufacturing, whether new laws are needed and what they would look like, and the applicability and enforceability of current and future IP laws in a 3D printed world. Interspersed with detailed analyses of the potential impact of 3D printing on patent, copyright, trade secret, trademark and trade dress, and design laws, and the effect of such laws on 3D printing, are intellectually stimulating essays on the potential economic and societal effects of 3D printing. The book wraps up with a fascinating discussion of the emerging issue of 3D printcrime. This book is a must-read for anyone interested in the intersection of IP law and 3D printing, and beyond.' --John Hornick, author of the award-winning book, 3D Printing Will Rock the World and Finnegan LLP'3D Printing and Beyond serves as a helpful guide for thinking about patents, design protection, trademark, and copyright in relation to 3D printing in three important jurisdictions. It is a useful resource for anyone trying to begin to understand the challenges that emerge as this technology matures and reaches deeper into our everyday lives.' --Michael Weinberg, New York University, School of Law, US'As a pioneer in the 3D printing industry for the past 30 years, Materialise has head started some of the most innovative projects. As such, we understand the technology and the challenges of creating digital supply chains very well. Now that the technology is becoming more broadly adopted and many companies see the great potential of 3D printing to produce mass customized products, it is very important to understand the emerging intellectual property and legal challenges. Therefore, we very much welcome this book's effort to go beyond the hype and raise some important questions surrounding intellectual property and regulation concerning the challenges and opportunities of 3D printing as an enabler of digital supply chains. Now, more than ever, it is time to raise such questions on how we are going to collaborate in the future between the private and public sectors in order to make sure that we do not inhibit innovation while creating something that is good and safe for our society.' --Lieven Claerhout, Bram Smits and Materialise, BelgiumTable of ContentsContents: Preface Introduction From the maker movement to the 3D printing era: opportunities and challenges Dinusha Mendis, Mark Lemley and Matthew Rimmer 1. IP in a world without scarcity Mark A. Lemley Part I United Kingdom 2. Mind the gap’: From engravings to 3D designs and 3D scans: re-evaluating copyright law in a 3D printing world Dinusha Mendis 3. Design rights and 3D printing in the UK: Balancing innovation and creativity in a (dis)harmonised and fragmented legal framework Thomas Margoni 4. Digital trade mark infringement and 3D printing implications: What does the future hold? Dukki Hong and Simon Bradshaw 5. 3D printing and patent law – a UK perspective: apt and ready? Marc D. Mimler 6. Transformative technologies and responsive legal scholarship Roger Brownsword Part II United States of America 7. 3D printing and US copyright law: implications for software, enforcement and business strategies Peter S. Menell and Ryan Vacca 8. Integrating a classic tool for a modern US challenge: US design patents implications for 3D printing Elizabeth Ferrill, Robert MacKichan, Christopher McKinley and Kelly Horn 9. How 3D printing disrupts trade dress protection and resurrects the need for source and quality assurance Deven Desai 10. Remedies for digital patent infringement: A perspective from USA Timothy Holbrook 11. How democratized production challenges society’s ability to regulate Deven Desai Part III Australia 12. Makers Empire: Australian copyright law, 3D printing and the ‘Ideas Boom’ Matthew Rimmer 13. ‘Substantial similarity’ under Australian design law: application to 3D printing Tyrone Berger 14. Trade mark controversies in 3D printing: An Australian perspective Amanda Scardamaglia 15. The reform challenge: Australian patent law and the emergence of 3D printing Jane Nielsen and Dianne Nicol 16. Don’t believe the hype? Recent 3D printing developments for law and society Angela Daly Conclusion: The future of printcrime: intellectual property, innovation law and 3D printing Dinusha Mendis, Mark Lemley and Matthew Rimmer Index

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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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