Patents law Books

Book SynopsisThis book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry’s approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.Table of Contents1. Regulating the EU Pharmaceutical Sector: A Multilayered Challenge 1. The Pharmaceutical Sector: A Need for Regulation 2. The Structure of the Pharmaceutical Industry in Europe 3. EU Competence in the Field of Public Health 4. Effective Legislation and Regulatory Rights 5. The Structure of the Book 2. Setting the Stage for Regulatory Rights: The Regulatory Agencies and the Marketing Authorisation Procedure 1. Regulatory Authorities 2. The Marketing Authorisation Procedure 3. Concluding Remarks 3. Data Exclusivity 1. The Legal Framework 2. Clinical Data 3. The Marketing Authorisation Procedure and Directive 2001/83 – Original Pharmaceuticals 4. Marketing Authorisation for Generic Products 5. The Weaknesses of the System 6. Data Exclusivity for Paediatric Medicines that are Not Patent-Protected 7. Concluding Remarks 4. The Supplementary Protection Certificate 1. Background to the Legal Framework 2. The Legal Framework 3. The Subject of Protection 4. The Rights Granted 5. The SPC Beneficiary 6. Concluding Remarks 5. The Paediatric Extension 1. Background 2. The General Legal Framework 3. A New Committee to Implement the Legal Framework: The Role of the Paediatric Committee (PDCO) 4. The PIP 5. PIP Compliance Control 6. Exemptions and Waivers 7. The Incentives of the Regulation 8. Rewards for Orphan Medicinal Products under Regulation 1901/2006 9. Other Incentives in the System 10. Post-approval Obligations 11. Concluding Remarks 6. Orphan Drugs 1. Background to the Legal Framework 2. Procedural Aspects 3. The Criteria for Orphan Drugs Designation 4. Marketing Authorisation of Orphan Drugs 5. The Incentives of the Orphan Drug Designation 6. Post-grant Obligations of the Sponsor 7. Difficulties in the Interpretation of Orphan Drugs Regulation Case Law 8. Concluding Remarks 7. Advanced Therapy Medicinal Products 1. The Legal Framework 2. Definitions of Key Terms in the ATMP Regulation 3. The ATMP Regulation and Other European Legislation 4. Marketing Authorisation for ATMPs 5. Post-authorisation Requirements 6. Concluding Remarks 8. How Effective is the Effectiveness Test in the Field of Regulatory Rights? 1. The Objectives 2. The Contents 3. The Context 4. The Results 5. General Conclusions

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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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