Patents law Books

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

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Book SynopsisThis collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challengesTrade Review'The editors have mustered a wide range of authors, including legal practitioners, academics and a Constitutional Court Justice, to opine on a broad range of topical issues confronting rule-makers concerning pharmaceutical patent law. This diversity makes for a varied discussion.' John A. Tessensohn, European Intellectual Property Review 'A solid reference book for scholars and those interested in governments’ struggle between incentivising innovation and access to affordable medicine.' John A. Tessensohn, European Intellectual Property ReviewTable of Contents1. Introduction: A Holistic Approach to Pharmaceutical Patent Law and Policy, Bryan Mercurio and Daria Kim Part 1: Pharmaceutical Patents and Related Types of Protection 2. Patentability of Pharmaceutical Inventions under TRIPS: Domestic Court Practice Testing International Policy Space, Roberto Romandini and Henning Grosse Ruse-Khan 3. Biologics, Biosimilars and Other Idiosyncrasies, Yaniv Heled 4. Index of Data Exclusivity and Access (IDEAS): An Analysis of Test Data Exclusivity Provisions in Free Trade Agreements and National Laws, Owais Hassan Shaikh 5. Patent Linkage Regulations: The Importance of Context and of Balancing Competing Interests, Bryan Mercurio Part 2: Balancing Patent Protection with Available Flexibilities 6. The Bolar Exception: Legislative Models and Drafting Options, Carlos Correa 7. Compulsory Licensing: Threats, Use and Recent Trends, Chang-fa Lo 8. A Manufacturing for Export Exception, Xavier Seuba, Luis Mariano Genovesi and Pedro Roffe Part 3: A Broader View on Incentives for Pharmaceutical Innovation 9. The Price of Exclusivity: The Economics of Patent Extensions and Data Protection, Aidan Hollis and Paul Grootendorst 10. Rationalizing Innovation Incentives under Drug Approval Regulation: National Policy Perspective, Daria Kim 11. The Trans-Pacific Partnership Agreement and Its Implications for Access to Medicine, Jakkrit Kuanpoth

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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 SynopsisEconomic growth has traditionally been attributed to the increase in national production arising from technological innovation. Using a panel of seventy-nine countries bridging the North-South divide, Patent Intensity and Economic Growth is an important empirical study on the uncertain relationship between patents and economic growth. It considers the impact of one-size-fits-all patent policies on developing countries and their innovation-based economic growth, including those policies originating from the World Intellectual Property Organization, the World Trade Organization and the World Health Organization, as well as initiatives derived from the TRIPS Agreement and the Washington Consensus. This book argues against patent harmonization across countries and provides an analytical framework for country group coalitioning on policy at UN level. It will appeal to scholars and students of patent law, national and international policy makers, venture capitalist investors, and research anTable of ContentsIntroduction; 1. Setting the framework: patenting and economic growth policy; 2. Convergence clubs, coalitions and innovation gaps; 3. Institutions, gerd intensity and patent clusters; 4. Gerd by type, patenting and innovation; 5. Patent intensity by employment and human resources; 6. Spatial agglomeration of innovation and patents; Conclusion; Appendix; Index of persons; Index of subjects; Index.

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Book SynopsisThis book provides an in-depth study on current perceptions of, and responses to, fragmentation in the European patent system (EPS). For decades, attempts have been made to address this fragmentation by introducing a unitary patent system. The most recent attempt, the EU unitary patent system, will be the first of its kind. It is expected to significantly change the EPS. However, rather than reducing existing fragmentation, it will likely add to it. Based on an analysis of the current and forthcoming system, the book argues that the inherent nature of fragmentation within the EPS needs to be recognised and suggests that a multifaceted approach is required to respond to it. Uniquely, it draws on work regarding fragmentation outside of the patent and intellectual property regimes, gaining insights from both European law-making and the international legal system. These insights are used to investigate current responses to fragmentation in the EPS. Interpretations of substantive patent law are examined, including claim construction (Actavis v Eli Lily), exceptions to patentability related to uses of human embryos for industrial or commercial purposes (WARF, Brüstle, ISCC), and products resulting from essentially biological processes (Broccoli and Tomatoes II, G3/19). Attempts towards convergence in these areas have had mixed results and in some instances fragmentation may be necessary. However, similar techniques to those applied in the international legal system to respond to fragmentation are being used in the EPS, and, where this is seen, it has been to good effect. It is argued that these methods should be recognised, structured, and promoted to make our response to fragmentation more effective. Fragmentation and the European Patent System will be of interest to academics, students and practitioners looking for a new perspective on the EPS.Table of ContentsIntroduction I. Background II. The European Patent System III. Terminology IV. Perspectives on Fragmentation V. Outline PART I FRAGMENTATION AND THE EUROPEAN PATENT SYSTEM TODAY 1. Existing Routes to Patent Protection in Europe I. National Patent Systems II. The European (EPC) Patent System III. The International Patent Application IV. Existing Fragmentation 2. Forthcoming Route to EU Unitary Patent Protection I. Background to the Unitary Patent Package II. The Unitary Patent Package III. Concerns Related to the Unitary Patent Package IV. Further Fragmentation PART II ALTERNATIVE PERCEPTIONS OF FRAGMENTATION 3. Fragmentation in European Law-Making I. Constructing Europe and the European Patent System II. The Impact of Expansion III. Fragmentation as a Means of Integration 4. Fragmentation in the International Legal System I. Fragmentation in the International Legal System II. Application to the European Patent System III. Fragmentation as an Inherent Aspect of a Legal System PART III FRAGMENTATION AND SUBSTANTIVE PATENT LAW 5. Responding to Fragmentation as an Inherent Aspect of the European Patent System I. Areas of Divergence II. Towards Convergence – Judicial Dialogue and Cooperation III. Fragmentation as an Inherent Aspect of the European Patent System 6. Accepting Fragmentation as a Necessary Aspect of the European Patent System I. The Impact of the Biotech Directive II. Interpretations of the Exceptions to Patentability III. Impact of the Unitary Patent Package IV. Considering Diversity and Value Pluralism when Responding to Fragmentation Conclusion: Fragmentation and the European Patent System

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Book SynopsisThis new edition captures all of the recent and rapidly emerging changes in case law and the America Invents Act, yet retains its student- and professor-friendly approach to the policies and rules of patent law. This version teaches the far-reaching legal tenets of patent law that are venerable and yet as current as the latest developments from the laboratory bench. Like its successful predecessors, this casebook draws on insights from other areas of U.S. law as well as from aspects of foreign systems. In particular this new edition features new chapters on the Patent Trial and Appeal Board, Standard Essential Patents, and prior art under the AIA.

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Book SynopsisThis new book merges the concepts of traditional agriculture, crop sustainability, and intellectualproperty rights associated with plant protection and agricultural products. It discusses various strategies associated with crop tolerance to adverse environmental conditions and also highlights the role of agricultural intellectual property rights, along with the implications for plant patents, protection of farmers’ rights, and geographical indication in plant products, to provide a broader outlook toward strategies for sustainable agriculture and global food security associated with IPR.The chapters provide an overview of sustainable crop cultivation in traditional agriculture as well as with new biotechnological approaches. The volume explores several stress resilience strategies and issues for crops, considering how to mitigate the effect of increased carbon dioxide concentration, heavy metal pollution, over-salinized soils, and cold spells. It also discusses how to make desert farming more efficient; how to increase abiotic stress tolerance of crops with grafting, seed soaking/priming, soil amendment, and more.The chapters on agricultural intellectual property rights address IPR in conjunction with food security, the rights of farmers, legal applications and protection of plant patents, protection of traditional knowledge, international legal issues, and plant variety protection rights in agriculture and more.Table of ContentsPart I: Sustainable Crop Cultivation 1. Sustainable Crop Cultivation: A Comprehensive Update 2. Traditional Agriculture: A Sustainable Approach towards Attaining Food Security 3. Plant Bioactive Compounds: Biotechnological Applications for Novel Molecules Part II: Stress Resilience Strategies in Crops 4. Rice Physiology and Sustainability in the Face of Increasing Carbon Dioxide Concentration 5. An Analysis of the Physiological and Biochemical Attributes in Tomato Fruits Affected by Salinity Stress 6. Crop Improvement in Deserts 7. Grafting, Seed Soaking/Priming, Soil Amendment, and Foliar Application as Tools to Increase Abiotic Stress Tolerance of Crops 8. Heavy Metal Stress Tolerance in Plants: Signaling Responses and Role of Plant-Microbe Association 9. Hydrogen Peroxide as Signaling Molecule in Plant Abiotic Stress 10. Plant Cell During Cold Stress: Sensing, Signaling, and Regulations Part III: Traditional Knowledge and Intellectual Property Rights: Implications in Plant Science 11. Intellectual Property Rights Vis-À-Vis Food Security: A Critical Analysis 12. Repatriation of Traditional Knowledge through the Lens of International Legal Instruments 13. International Convention for Protection of Geographical Indication and Its Application in Agriculture: A Legal Perspectives 14. Farmers’ Rights: An Indian Scenario 15. From Green Revolution to Green Innovation: How IP and Trademarks Catalyze Commercialization of Agriculture and Plant Products 16. Delineation of Legal Application and Protection of Plant Patent: A Critical Study 17. IP Protection of Traditional Knowledge (TK) and Traditional Cultural Expressions (TCE) in Regions of Northeastern India: An Ecological Context 18. International Legal Issues and Plant Variety Protection Rights in Agriculture

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Book SynopsisPatent Transactions in the Life Sciences is designed to provide guidance on the structure and detail of those agreements in the life sciences sector that are based on its most import assets - patents and know-how. As a companion to Intellectual Property in the Life Sciences, it is intended to cover the practical what, where, why and when of patent transactions in this sector, under the leading legal regimes. The book explains the rights that underpin life sciences transactions and describes the architecture, features and purpose of those transactions. It covers issues from the basics of a licence and assignment to complex agreements. The book also explores the types of deal that commonly feature in the industry at the corporate level and how patents fit in. Associated issues of licence disputes, competition rules, securitisation, insolvency and taxation are also examined. This new guide will be a valuable resource for lawyers, in-house counsel and other professionals advising on transactions in the life sciences industry, particularly where they have global reach.Table of ContentsIntroduction 5 Paul England Taylor Wessing Looking ahead to 13 the unitary patent Paul England Taylor Wessing Belgium 19 Philippe de Jong Christophe Ronse ALTIUS Canada 35 Rory Cattanach Kevin Fritz Wildeboer Dellelce LLP Noel Courage Bereskin & Parr LLP China and Hong Kong 51 Joanna Chan Lewis Ho Monique Lee Dechert LLP Denmark 85 Klaus Ewald Madsen Christian Bennet Rosenbak Bech-Bruun France 99 Laetitia Benard Allen & Overy LLP Germany 121 Nicole Battistini-Kohler Manja Epping Michael Gaul Christof Hohne Matthias Hulsewig Anja Lunze Steffen Wirsing Taylor Wessing India 153 Disket Angmo Fiona Desouza Jose Madan Khaitan & Co Israel 169 Uri Fruchtman Liad Whatstein Dr Shlomo Cohen & Co Italy 191 Luca Trevisan Trevisan & Cuonzo Japan 209 Frederick Ch'en Eiichiro Kubota Hogan Lovells Netherlands 237 Carreen Shannon Deterink South Korea 255 Mikyung Choe H Joon Chung Yoon Young Huh Ji Eun Kim Jongguk Pak Kim & Chang Sweden 271 Jennie Klingberg Odd Swarting Setterwalls Switzerland 285 David Broenimann Christoph Heiz Simon Holzer Kilian Scharli Andrea Sieber Meyerlustenberger Lachenal United Kingdom 303 Malcolm Bates Colin McCall Louisa Penny James Stewart Tim Worden Taylor Wessing LLP United States 343 Chuck Larsen Anita Varma Ropes & Gray LLP About the authors 373

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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 SynopsisIn this thoroughly updated second edition, Matthias Herdegen provides a comprehensive and contemporary assessment of the regulation of biotechnology processes and products from an international and comparative perspective, complete with analysis of intricate legal and ethical debates.Trade Review‘The 2nd edition of this magisterial work remains an essential reference work on the international law of biotechnology, now updated with the latest developments. The book is and remains a must-read for anyone interested in biotechnology law and a valuable reference guide for experts working in this field.’ -- Prof. Dr. Claudia Seitz, M.A. (London), Professor for Public Law, European Law, International Law and Life Sciences Law at the Faculty of Law of the Private University in the Principality of LiechtensteinTable of ContentsContents: Preface 1. Introduction: regulation of biotechnology, between anxieties and trust in scientific progress 2. Law and ethics: an intriguing interplay 3. Risks, perceptions and the law: regulatory approaches to risk 4. The biotech challenge to human dignity, life and freedom of choice: human rights 5. From test tube babies to human clones: salient issues in the international law of biomedicine 6. GMOs, crops and precaution: biotechnology and international protection of the environment 7. Combating biopiracy: access to genetic resources 8. Phantom risks and legitimate concerns: biotechnology and international trade law 9. Inventors’ claims to life: intellectual property rights and biotechnological inventions 10. Conclusion: legal values, individual rights and democratic choices in a pluralist world Index

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Book 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 SynopsisPatents are a vital asset in the modern business world. They allow patent holders to introduce new products in to a market while deterring other market players from simply copying innovative features without making comparable investments in research and development. In years past, a few patents may have provided adequate protection. That is no longer the case. In today''s world, it is critical that innovative companies protect the features of their products that give them a competitive advantage with a family or portfolio of patents that are strategically generated to protect the market position of the patent holder. A patent portfolio that deters competitors from introducing competitive products in a timely manner can be worth billions of dollars. Anything less than this is an expensive and possibly fatal distraction. This book provides a strategic framework for cost efficient engineering of patent portfolios that protect your investments in research and development and that extendTable of Contents1 An Introduction to Patent Engineering 1 2 Patents and Patent Strategies—What They Are and Why You Need Them 17 3 Developing a Patent Strategy and Patent Engineering 33 4 Implementing Patent Strategies and the Application Process through Patent Engineering 59 5 The Structure of a Patent 81 6 Inventions and Inventorship: Challenges and Complications 105 7 Patent Engineering and Patent Prosecution 127 8 Controlling the Costs of Generating and Maintaining a Patent Portfolio through Patent Engineering 143 9 Patent Engineering in a Global Economy 153 10 Avoiding an Infringement Lawsuit through Patent Clearances 169 11 The Role of the Patent Engineer 189 Index

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Book SynopsisThis book provides practical and detailed account of all procedural aspects of the Unified Patent Court and Unitary Patent system. The book also explains how the UPC works in the context of the wider European patent system, particularly the EPO and the UK. It considers how parties can use it to enforce or revoke European patents and the Unitary Patent, in particular:- The procedures of the UPC from initiating proceedings to appeal, damages and costs hearings;- Rules on competence, substantive law, jurisdiction, language and judges;- The operation of the system alongside the national courts of the contracting countries, the European Patent Office opposition and appeal procedure, and parallel English Patents Court proceedings. NEW TO THE 2ND EDITION: Additional chapters on the impact of the UPC and Unitary Patent on managing licences, and on confidentiality; coverage of the latest UPC guidance; references and case notes on every significant procedural case from the UPC divisions and the Court of Appeal; and coverage of every Rule of the Rules of Procedure. The book is written by a team of patent experts with many years of experience in patent litigation in France, Germany, the Netherlands, and the UK, as well as hands-on experience of running cases in the UPC from its inception. It provides insights from national and UPC practice on the features above and identifies points of interpretation. A must read for private practitioners and in-house counsel.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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Book SynopsisThe Economic Valuation of Patents provides an original and essential analysis of patent valuation, presenting the main methodologies to value patents in different contexts. Starting with an analysis of the relevance of patent valuation from a strategic, economic and legal perspective, the book undertakes a thorough review of the existing financial and qualitative valuation methodologies. The contributing authors, IP experts from academia and business, discuss the application of valuation issues in various contexts such as patent portfolio management, licensing agreements, IP litigation, IP-backed finance and accounting. For each topic, an introductory theoretical background is provided and specific application contexts are then investigated. This multidisciplinary book bridges theory and practice in a unique and novel way that will be appreciated by graduate students, scholars and practitioners alike.Contributors: M.A. Bader, O. Gassmann, H. Goddar, M. Granieri, K. Laursen, M.I. Leone, S. Morricone, U. Moser, F. Munari, M.C. Odasso, N. Omland, R. Oriani, L. Sereno, M. Sobrero, L. Toschi, P.M. ValentiTrade Review'In depth knowledge and scientific approach are used to improve patent valuation techniques. . . a dream book for both researchers and practitioners interested in identifying the value of creative minds.' --Bruno van Pottelsberghe, Solvay Brussels School of Economics and Management, ULB, Belgium'This book fills an important gap in the literature and will be very useful both to students of intellectual property and practitioners confronted by the problem of valuing their patent portfolios. An excellent overview of an evolving and challenging area, it provides the necessary background to thinking about the problem of valuation and describes all the major methods in use, including the real options approach.' --Bronywn H. Hall, University of California, BerkeleyTable of ContentsContents: Introduction Federico Munari and Raffaele Oriani PART I: PERSPECTIVES ON PATENT VALUE 1. Why, When and How to Value Patents? An Introduction Federico Munari and Raffaele Oriani 2. A Law and Economics Introduction to Patent Law and Procedure Massimiliano Granieri 3. Economic and Management Perspectives on the Value of Patents Federico Munari and Maurizio Sobrero 4. Patent Exploitation Strategies and Value Creation Maria Isabella Leone and Keld Laursen PART II: PATENT VALUATION METHODS 5. Traditional Valuation Methods: Cost, Market and Income Approach Heinz Goddar and Ulrich Moser 6. Advanced Valuation Methods: The Real Options Approach Raffaele Oriani and Luigi Sereno 7. Valuing Patents through Indicators Nils Omland PART III: PATENT VALUATION CONTEXTS 8. Patent Portfolio Management Martin A. Bader and Oliver Gassmann 9. Patent Licensing Contracts Massimiliano Granieri, Maria Isabella Leone and Raffaele Oriani 10. Economic Approaches to Patent Damages Analysis Paola Maria Valenti 11. Valuing Patents for Accounting Purposes Serena Morricone 12. Patent-backed Finance Federico Munari, Maria Cristina Odasso and Laura Toschi 13. Stock Market Valuation of Patent Portfolios Serena Morricone and Raffaele Oriani Index

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