Putting Intellectual Property to Work: Experiences from Around the World

Abstract: For smallholder farmers in Africa, yields of major staple crops (maize, sorghum, millet, cassava, cowpea, bananas/ plantains) have remained stagnant or even declined in the past 40 years. Numerous biotic and abiotic stresses have contributed to this dire trend. Local research efforts to overcome these stresses have been hampered by declining support for agricultural research, limited access to elite genetic material and other technologies protected by IP rights, and the absence of commercial interest in these crops from private owners of agricultural technologies. The African Agricultural Technology Foundation (AATF) is a new initiative addressing the challenge of reversing the negative trend in agriculture by negotiating access to proprietary technologies and facilitating their delivery to smallholder farmers in Sub-Saharan Africa.

This chapter addresses the IP issues and partnership arrangements associated with the access, development, and deployment of agricultural technologies in Sub-Saharan Africa by AATF. The chapter explores the model developed by AATF, which incorporates the acquisition, development, and deployment of new technologies from private sector partners, to try to address the agricultural needs of resource-poor smallholder farmers in Sub-Saharan Africa.

Abstract: An independent nonprofit research institution, the Donald Danforth Plant Science Center has an international mission to address global challenges in human health, nutrition, agricultural sustainability, and the environment. The Danforth Center contributes to fulfilling this mission through collaborative research, training, and capacity building. As part of this objective, the Office of Technology Management and Scientific Partnerships at the Danforth Center, lead by the author of this chapter, has emerged as a leader in developing and implementing terms for humanitarian access to technology and has been actively involved in licensing enabling technologies for humanitarian projects. These activities include active participation and support for the creation of PIPRA, among other nonprofit organizations. The current chapter discusses the Danforth Center’s philosophy with respect to the protection and sharing of IP (intellectual property) rights, the reservation of rights for humanitarian projects, and best practices to enhance and maximize value creation through technology licensing. The chapter provides examples of the Danforth Center’s best practices and model documents for the establishment of interinstitutional and international collaborations and scientific partnerships. Included with the chapter are specific examples of the Danforth Center’s humanitarian-use language, interinstitutional agreements, nonasserts, enabling technology licenses, memorandums of understanding (MOUs), and other framework documents.

Abstract: This chapter describes the current status of IP (intellectual property) management in the areas of health and agriculture in India with a focus on post-2005, at which time India became fully complaint with the Agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights). The major policy trends existing in India include (1) public sector expenditure for R&D is on the rise and is currently about US$5.0 billion (one US$ equals about 4 Rs); (2) pharma industry R&D expenditures were on the rise and had reached Rs 15.0 billion, or close to 4.0% of their turnover; (3) several major policy initiatives had been undertaken by the government, including the National Health Policy (2002), National Policy on Indian Systems of Medicine and Homeopathy (2002), and National Biotechnology Policy (2005). Other major initiatives to promote IP generation include the creation of a Central Drug Administration, a new national body for the registration of medical devices, a National Registry for Clinical Trials, and a law similar to the Bayh-Dole Act that provides for the sharing of IP with inventors. The Departments of Science and Technology and Biotechnology, the Council of Scientific & Industrial Research, the Indian Council of Medical Research, the Indian Council of Agricultural Research, and so forth, have initiated large R&D programs in the health sector for the generation of new diagnostics, vaccines, and drugs largely focused on current health problems of India. A few indigenous products are being tested for safety and efficacy before use in the public health system. A new thrust and focus are being given for public–private partnerships involving both national and international partners. In agriculture, besides a substantial allocation of funds for R&D, two new initiatives—the National Agricultural Innovation Project (NAIP) and the Indo-U.S. Agricultural Knowledge Initiative (AKI) were started in 2005. The NAIP is a World Bank-supported project worth approximately Rs 11.7 billion that is expected to strengthen basic and strategic research in agriculture in India. The AKI is expected to address a large number of issues including education, research services, and commercial linkages in agriculture.

Abstract: This chapter describes current and historical trends and issues related to intellectual property (IP) management in Japan. It gives a history of Japan’s national IP system in order to provide an understanding of the nature of the system and why and how it was established. The chapter also describes current government efforts to provide insights into the system’s future. With regard to current IP issues, two topical issues are discussed: industry-university collaboration on R&D and employees’ inventions. Japan’s efforts to resolve these issues may be helpful for other countries that are grappling with similar issues.

The chapter also details health and agricultural IP issues in Japan. It discusses and compares with the practices of other countries the patentability of medical methods and exemptions for the experimental use of patented products. Furthermore, the chapter offers an overview of Japan’s national policy on agricultural R&D and biore-source centers (the functioning of which greatly involves the transfer of materials with IP rights). RIKEN (The Institute of Physical and Chemical Research) is offered as a case study to clarify the policies and issues discussed.

Finally, for the benefit of other countries that are coming to terms with IP management issues, the chapter offers some lessons learned by Japan that have helped shape its national IP policy, strategy, and institutional IP management.

Abstract: This chapter presents Brazil’s intellectual property (IP) system and identifies relevant experiences of IP management in the fields of health and agriculture. Brazil takes advantage of the flexibilities offered by relevant international agreements, such as the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and attempts to implement an equitable system. During the 1990s, Brazil revised its industrial property and copyright laws, and other related laws, and enacted new legislation that includes provisions for plant variety protection and for access to biological resources.

Abstract: Health and agriculture are at the very core of the European Union’s policies for socio-economic development. One of its most active efforts is the Framework Programmes for Research and Technological Development. With a specific focus on international cooperation, this is the European Union’s main financial instrument to promote and strengthen research and technological cooperation within the European Union (E.U.). Through the E.U. Framework Programmes, actors from different countries and sectors (industry, research centers, small- and medium-sized enterprises, universities, and so on) work together to improve science and create a better standard of living.

Given the massive movement of scientists and experiences exchanged through these Programmes, it seems that the E.U. is on the right track. However, these Programmes can only be used to their fullest potential when participants understand and appropriately handle the intellectual property rules governing them.

Abstract: This brief case study describes how the International Centre of Insect Physiology and Ecology (ICIPE) helped African growers maintain access to foreign markets and improve livelihoods by being able to achieve standards certification for agricultural export commodities. The process involved a characterization of the problem and a conceptualization and execution of a solution. The solution included creating a regional certification body in East Africa capable of providing globally recognized certification at costs that were locally affordable. The level of technical know-how needed by the certification body in order to be effective was significant, so the expertise of ICIPE was instrumental in creating the local certification body. Ongoing certification services provided by the certification body are highly market oriented, and because of this orientation the group was spun off as a private company, as Africert Limited.

Abstract: This chapter discusses how Brazil has dramatically increased technology transfer and innovation through the State University of Campinas, or Unicamp. The leader in patenting and licensing activities in Brazil and Latin America, Unicamp has vaulted to this position in the short span of two and a half years through its technology transfer office, Inova. Providing background information about Brazil’s legal framework and practices, especially as it concerns the ownership of intellectual property and benefit sharing, the chapter discusses government incentives for innovation in light of Inova’s impressive results. Two successful cases of technology transfer are presented as guides to realistic expectations about investments, terms of license, and royalties.

Abstract: Fundación Chile is a private, non-profit organization active in developing applications of biotechnology that can improve productivity and add value to existing agricultural and natural resource products of Chile. Fundación Chile seeks to create technology-based companies that would have significant economic and social impact in Chile. This case study details Fundación Chile’s initiative in grape biotechnology: globally assessing the availability and priority of different technological components and initiating efforts to access, license, and transfer those key technologies for the initiative.

Abstract: Plant breeders and research managers need to understand how intellectual property (IP) restrictions on germplasm and traits affect freedom to operate for a breeding program. Access to patented germplasm and traits is restricted and can only be used under some form of material transfer agreement or similar contract. Patented materials have to be maintained under strict provisions of the contract. This adds to the cost of breeding, parent seed, and production programs. Moreover, maintaining separate versions and precise records of patented materials increases the number of seed lots that a program must maintain. For example, different versions of inbred lines of maize must be maintained for each patented trait. Otherwise, stacking two or more traits produces lines with each trait and also lines with every combination of those traits.

Abstract: PATH is an international, nonprofit organization that creates sustainable, culturally relevant solutions, enabling communities worldwide to break longstanding cycles of poor health. By collaborating with diverse public and private sector partners, PATH helps provide appropriate health technologies and vital strategies that change the way people think and act. PATH’s work improves global health and well-being. Over the past 28 years, PATH has demonstrated that public–private partnerships (PPPs) can effectively address unmet public health needs, particularly when managed with a clear understanding of both public and private sector objectives. Indeed, collaboration between public sector and private sector partners is an especially valuable way to develop and advance appropriate health technologies for use in developing countries. When developing and managing PPPs, PATH recognizes that intellectual property (IP) is an especially important component in the range of variables that affect the economic, technical, and programmatic feasibility of a new health technology intervention. Our goal, therefore, is to incorporate IP considerations as a fundamental part of the PPP process. We seek to manage IP strategically to avoid or quickly overcome any IP-related roadblocks. Using three case studies, this chapter illustrates PATH’s strategies for private sector collaboration, as well as PATH’s approaches to managing IP.

Abstract: One of the primary missions of the University of California Agricultural Experiment Station (AES) is to create knowledge and develop technologies that improve the productivity and environmental sustainability of agriculture in California. In addition to the public release of information and the educational activities of cooperative extension services, the University of California places the inventions of AES faculty directly into commerce through the process of patenting and technology transfer. This channel is particularly useful—and often essential—when further financial investments are necessary to develop the technology for practical applications or to manufacture, market, and distribute new products that incorporate the new technology. This report documents the patenting and formal technology transfer activities of the University of California Agricultural Experiment Station over the last 40 years.

More than 800 inventions have been reported by AES researchers between 1960 and 2001. These inventions are categorized into the five broad technology areas: biotechnology (49%), plant varieties (19%), chemicals (14%), equipment/machinery (13%), and environmental (1%). Biotechnology inventions were entirely absent until the mid-1980s, but the category has grown rapidly over the last 15 years. The growth in the number of biotechnology-related inventions has occurred not at the expense of inventions reported in the areas of plant varieties, agricultural equipment, or novel chemicals, all of which have shown a relatively stable level of activity.

Financial returns from the licensing of AES inventions was US$1.4 million in fiscal year 1982 (2.5 million in 2001 dollars) but had grown to US$12 million by fiscal year 2001. After accounting for expenses associated with patenting new inventions and distribution of a share of income to inventors, AES inventions returned over US$6 million to the university in fiscal year 2001. Since 1982, the cumulative financial return has totaled US$105.2 million in fees and royalties. About 87% of that income has been derived from the licensing of plant varieties in spite of the fact that they compose only 19% of the AES inventions, indicating the commercial importance of UC plant varieties. To date, relatively few biotechnology- or environmental-related inventions have been commercialized, but the extensive and growing UC portfolio in these areas should provide a strong base for future licensing activity.

Abstract: For the People’s Republic of China, intellectual property (IP) is a new legal and social concept. Formal legislation was first introduced in the 1980s and was later strengthened. Due to recent publicity, however, social awareness of IP rights in China has grown. Following a series of ministerial and commission rules concerning technology transfer, universities now usually own the IP resulting from government-funded research. Not surprisingly, the number of patent applications filed by Chinese universities has increased rapidly, exceeding 13,000 in 2004. But such numbers may reflect a trend for researchers and institutions to use patents as a way of enhancing their reputations, rather than for actually transferring or commercializing technology. Most universities still lack institutional IP policies and independent offices responsible for IP management. Rates of technology transfer and commercialization, while difficult to observe, remain low. Still, some world-class universities, such as Tsinghua University and Beijing University, have become adept at IP management. These are both an exception to and an example for other universities in China, having successfully adapted IP management policies and practices to the country’s legal and economic circumstances.

Abstract: This chapter summarizes how intellectual property (IP) arising from within the National Health Service in England is managed within the context of a national framework for managing IP from public sector research in the United Kingdom. Describing how the policy framework was developed and how National Health Service organizations were set up to manage IP, this chapter also charts progress in the administration of health R&D and the management of IP and summarizes how IP management complements R&D in the National Health Service.

Abstract: In the late 1990s, a consortium of public sector organizations commercialized the first and still-major food biotechnology product developed by public sector organizations. The author represented the Papaya Administrative Committee, an organization of papaya growers in Hawaii, in obtaining patent licenses necessary for the commercial introduction of a disease-resistant transgenic papaya. This chapter describes the approach taken in deciding what patents needed to be licensed, how the licenses were obtained, and how they were administered.

Abstract: During its relatively brief history of IP (intellectual property) rights protection, China has achieved early success, thanks to the strengthening of governmental IP rights legislation, the establishment of an IP rights management system, the promotion of public knowledge about IP rights, and increasing opportunities for international exchange and cooperation. IP rights protection in the fields of health and agriculture has increased investment in these sectors, encouraged innovation in health and agricultural science, increased farmers’ incomes, and improved the quality of life for Chinese citizens. Dramatic increases in patent applications in China suggest that widespread implementation and greater enforcement of IP rights are stimulating inventive activity, encouraging technology transfer, and driving greater and greater innovation.

Abstract: The Cohen-Boyer licensing program, by any variety of metrics, was widely successful. Recombinant DNA (rDNA) products provided a new technology platform for a range of industries, resulting in over US$35 billion in sales for an estimated 2,442 new products. Over the duration of the life of the patents (they expired in December 1997), the technology was licensed to 468 companies, many of them fledgling biotech companies who used the licenses to establish their legitimacy. Over the 25 years of the licensing program, Stanford and the University of California system accrued US$255 million in licensing revenues (to the end of 2001), much of which was subsequently invested in research and research infrastructure. In many ways, Stanford’s management of the Cohen-Boyer patents has become the gold standard for university technology licensing. Stanford made pragmatic decisions and was flexible, adapting its licensing strategies as circumstances changed.

Abstract: The history of technology transfer at Stanford goes back to an initial pilot program launched by Niels Reimers in 1970, a program that put the university in an excellent position to take advantage of the Bayh-Dole Act. Enacted in 1980, the act gave U.S. universities ownership of any patents developed using federal funds. Today, Stanford University and successful technology transfer are almost synonymous. But success is more than just a matter of timing. Stanford’s Office of Technology Licensing (OTL) takes a flexible, broad outlook on the development of its intellectual property that has made Stanford a favorite business partner. This chapter reveals the secrets behind the success of Stanford’s OTL.

Abstract: This chapter presents an operational model used by Fundación Chile to develop commercial biotechnology products. The first section highlights the challenges faced by a developing economy of which the main crops are so-called orphan crops. Fundación Chile’s experience has shown that establishing public–private collaborations and a solid international network are critical to overcoming obstacles and increasing the probability of success. Indeed, accessing various technology components and managing intellectual property and regulatory issues are serious challenges for a small, export-oriented economy like Chile, and Fundación Chile’s response has been to implement a model that includes the participation of companies and local research organizations with specific expertise at different points along the value chain. International agencies complement the activities and contributions of these local organizations. The chapter’s second section gives some specific examples of new products being developed with the new tools of biotechnology.

Abstract: This chapter provides a conceptual overview of Arizona State University’s mission, and explains how the university’s “technology translation” efforts support that mission. The chapter offers a rationale for why effective technology translation and commercialization are economically and socially relevant. A case study illustrates how a program established by Arizona State University’s technology commercialization group has led to significant returns for the university and the local community. The authors conclude that public and private institutions in both developed and developing countries can implement the concepts and strategies for technology commercialization described in the chapter.

Abstract: Technological innovation is increasingly recognized as an important tool for improving global health. The Office of Technology Transfer of the U.S. National Institutes of Health (NIH OTT) has increased its licensing of technologies for the prevention and treatment of neglected diseases to partner institutions in developing regions of the world. Other efforts have focused on providing assistance to indigenous institutions in building their technology transfer capacity. In addition to helping to achieve the primary objectives of meeting global public health needs and strengthening local R&D capacities, NIH OTT expects such efforts to have a positive impact on national policies on intellectual property rights, and, ultimately, to increase multinational investments in developing countries, which will likely result in an even greater effort to develop accessible therapies for those in need.

Abstract: This chapter shares the results of a project that analyzed the potential for consolidating patents in the malaria vaccine field. Goals include streamlining access to critical patents, advancing the development of products, and providing equitable access to the innovations. The study assessed the current status of the relevant patents and surveyed the holders of key patents to determine the availability for licensing. Other key activities included prioritizing patents with respect to a vaccine’s potential for success, identifying potential patent roadblocks by discussing the issue with patent holders, and proposing a mechanism for accessing key patents in the field of malaria vaccines. The potential role for some form of patent consolidation or technology trust, including pooling patents and technology, was explored. This chapter does not recommend developing a broad-based technology trust for existing malaria-antigen patents. Instead, several other steps are recommended to consolidate available rights and improve access for future patent families.

Abstract: The mission of the Drugs for Neglected Diseases initiative (DNDi) is to develop safe, effective, and affordable new drugs for patients suffering from neglected diseases and to ensure equitable access to these drugs. DNDi believes that intellectual property (IP) rights should not pose a barrier to access to these medicines. Hence, a balanced approach to IP management is critical for effective implementation of DNDi’s mission. The organization has written an IP policy that both encapsulates and articulates DNDi’s approach to IP based on core principles and beliefs. The policy reflects the DNDi philosophy, vision, and mission, ensuring that its products are accessible and affordable to patients who need them most. DNDi recognizes the reality of IP and seeks to implement its humanitarian mission using best, pragmatic practices for IP management. Indeed, DNDi has already demonstrated that this is feasible, having successfully negotiated with both private and public sector institutions in order to actualize its principled mission.

Abstract: The public sector is making substantially increased investments in health technology innovation through public/private partnerships to bring improved health technologies to underserved people in developing countries. These product-development partnerships, however, face a common problem: how to manage intellectual property (IP). Such management involves many issues. In relation to a case study, presented in this chapter, of plant-derived hepatitis B virus vaccine, the challenges involve obtaining freedom to operate, securing new intellectual property, and deploying intellectual property to developing countries. We conclude that while challenges abound, the IP issues are fairly clear and can be addressed with straightforward IP management approaches. The cost of managing the intellectual property is expected to be minimal on the price of the finished vaccine. In the medium term, an IP protection strategy might offset costs and generate modest income. Most important for the partnerships is to develop a clear, transparent IP policy, with emphasis on the licensing principles, so that products can be made available to developing countries at affordable prices.

Abstract: This chapter looks at the results of a unique public–private partnership instituted to provide resource-constrained farmers in the developing world with access to proprietary agri-biotechnologies. Eggplant, a widely consumed vegetable crop in the tropics, is commonly infested by the eggplant fruit and shoot borer (EFSB), which devastates both plants in the field during development and eggplant fruits after harvesting. The chapter considers the application of insect-resistance technology (based on the Cry1Ac protein from Bacillus thuringiensis) in eggplant, focusing on its sublicensing from a private company to a partnership of public institutes and agricultural universities in Bangladesh, India, and the Philippines.

Abstract: The University of California (UC), based on its mission as a land grant university, has a long history of seeking intellectual property protection for its research discoveries and managing those technologies for the public benefit. By some measures, the UC technology transfer program is the largest public program in the world. The program has evolved over the years but has always been at the forefront of intellectual property protection. This article focuses on the history, policy, and organizational framework of the UC technology transfer program, and the information discussed herein may be instructive to administrators and others seeking to learn from the UC experiences. The program has been administered through six functional departments: Information Technology and Communications, General Counsel (legal), Licensing, Patent Prosecution, Financial Management, and Policy Analysis and Development. Perhaps the most distinctive feature of the UC technology transfer system is the development of a distributed institutional network of ten university campuses, which operate under a common policy framework and share resources. At the same time, each office functions relatively independently of the others. This structure could be emulated and implemented at different scales, from a relatively small-scale research consortium made up of a network of institutions, to a larger-scale national network of universities, to a global-scale international network of research institutions linked by common policies and objectives.

Abstract: This chapter provides an analytical overview of technology transfer in South Africa. Technology transfer offices (TTOs) are relatively new in the country, and not all South African universities have explicit IP policies. The chapter discusses and analyzes the current performance of TTOs. Among other things, the results show that the income accruing to universities from technology transfer activities is not substantial, that there is a time lag before a TTO can generate sufficient income to become self-supporting, and that the performance of TTOs at different institutions varies widely. A history of public policy efforts to strengthen technology transfer in South Africa is provided, and the government’s 2006 publication of the Framework for Intellectual Property Rights from Publicly Financed Research receives considerable analysis. Other measures being undertaken to support technology transfer are also discussed, as are the problems that such efforts still face.

Abstract: The strawberry improvement program located at the University of California, Davis focuses on breeding cultivars for the strawberry industry in California, yet today it supports the majority of production of fresh-market strawberries globally. Around the world, UPOV-compliant Plant Breeders’ Rights (PBR) are the most common form of IP protections sought by University of California (UC) to protect its strawberry cultivars. Inside the U.S. and Canada, cultivars are licensed on a nonexclusive basis directly to nurseries. Outside of the U.S. and Canada, UC relies on business partners, referred to as “master licensees,” as intermediaries. A master licensee is provided with exclusive rights within a defined territory that includes the right to issue nonexclusive sublicenses to nurseries within that territory. Overall, a three-tier royalty structure is utilized, with growers inside California paying the least, growers in the U.S. outside of California and in Canada pay slightly more, and all other growers pay even more, a percentage of which is shared with the master licensee. The ultimate future of the UC strawberry breeding program is tied to the continued development of competitive cultivars, but the team is highly skilled and, partly due to the licensing program, funding is stable.

Abstract: Public-sector research institutions can use a variety of agreements to protect and manage intellectual property. These agreements are powerful tools to foster competition in the private sector and reduce prices for consumers in developing countries. This chapter provides an overview of the following types of major agreements—confidentiality, material transfer, development (in which the licensee is responsible for further development), co-development (in which two parties collaborate on continued development), and distribution—explains the functions of those agreements, and suggests strategies for their effective use. The chapter also discusses the meaning and usefulness of the standard elements and formulas found in such agreements. It explains the meaning and significance of the terms and language used and discusses such key issues as product liability, fees and royalties, and arbitration. The chapter emphasizes the importance of establishing and maintaining trust when negotiating and implementing agreements.

Abstract: This chapter presents a theoretical framework to explain the role of intellectual property (IP) in innovation and applies the framework to the growth of the pharmaceutical industry. Developing countries progress through stages of capability to reach the status of Innovative Developing Country (IDC). To reach the status of an IDC, countries need to give concerted attention to six components of product innovation: R&D in the public and private sectors, regulatory mechanisms for drugs and vaccines to achieve safety and efficacy, the ability to manufacture to high standards new health technology products, national distribution systems in both the public and private sectors, international distribution systems (including supply of drugs and vaccines through international organizations such as UNICEF, the operation of global funds, and trade among countries), and systems for managing IP.

An analysis of pharmaceutical innovation in Korea’s vaccine industry concludes that its success in developing its impressive capabilities was achieved by paying close attention to all six components of innovation. Yet unknown is the extent to which the Agreement on Trade-Related Aspects of Intellectual Property will stimulate or thwart progress in the other innovation components when IP is quickly moved to an advanced stage.

Abstract: Voluntary patent licenses are often difficult for institutions to obtain, particularly those in developing countries. This chapter discusses why, how, and by whom compulsory patent licenses may be obtained and used. The main focus is on patented research tools rather than patented end products.

Abstract: IP (intellectual property) rights can reward innovators and encourage investment in developing new products and services. However, the exclusionary power of IP rights can sometimes have negative effects, making technologies less accessible and, thereby, potentially impeding innovation. To make informed decisions about how to balance access and protection requires an understanding of both the traditional IP rights system (patents, copyrights, trademarks, and trade secrets) and alternative mechanisms for preserving access to technologies. This chapter provides a brief introduction to the public domain and defensive publishing and examines issues concerning the choice behind the choice of whether to publicly disclose or to patent an innovation. Discussing the strategic use of defensive publishing in IP management, the chapter considers both the utility of defensive publishing and its limitations for supporting broad innovation. After an examination of the public domain and how it relates to other open-access concepts, such as open source and the commons, the chapter focuses on the practical considerations involved when using public-domain technologies and defensive publishing to manage intellectual property.

Abstract: This chapter provides an overview of the current and potential impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on low- and middle-income countries. The chapter also summarizes the findings of a meeting in New Delhi, India and explores the legitimacy of concerns about TRIPS. Access to health products relies on many factors, including the successful innovation of new technologies. Innovation, in turn, is a complex process, involving many factors (intellectual property [IP] is just one) that influences product availability and price.

Pointing to the growth of global and national public–private product-development partnerships (PDPs), the chapter highlights one way these countries are seizing opportunities—and reveals how important effective IP management has become for them. Focused on high-priority diseases such as AIDS, malaria, and TB, PDPs require the development and implementation of sophisticated IP management policies and practices in both developed and developing countries in which PDPs operate. Finally, the chapter discusses the possible role of compulsory licensing and parallel trade. The value of these flexible options, provided by TRIPS, is yet undocumented and successfully implementing them represents a significant challenge. Crucially, countries have considerable freedom to control the effects of TRIPS on the availability of new health technologies. The countries can do this most effectively by building capacity for IP management and by formulating policies and practices, for courts, patent offices, and other institutions, that favor the poor.

Abstract: If universities adopt sound licensing practices, the universities will not only help stimulate investment in research on diseases that primarily afflict the poor in developing countries, but also ensure that the products of the research are affordable and widely available in those countries. Ensuring global access is one of the central goals of intellectual property management. But universities confront two main obstacles in their efforts to achieve the goal. First, university administrators, technology transfer officers, and business people are too often unaware of both the need to ensure access to new health technologies in developing countries and the manner in which patenting and licensing practices can be an integral component of global access strategies. Second, there is only a short history of experience in incorporating such concerns in negotiating licenses, so no best practices have yet evolved. This chapter offers a few possible approaches to ensuring broad access to university inventions while preserving incentives to development, including patenting inventions in a select list of developing countries. The chapter concludes by urging all of the players in this field to build upon their own experience and to take creative risks in the pursuit of new solutions.

Abstract: In the last decade, product development partnerships (PDPs) have become significant components of efforts to develop and disseminate therapies for diseases in the developing world. PDPs seek to fill a gap left by the private sector—a gap that leaves 90% of the world’s disease burden with only 10% of the world’s research money—through innovative, comprehensive partnership strategies that tap into the strengths of both the private and public sectors. This chapter, based on the proceedings of a conference titled Ensuring Global Access through Effective Management of Intellectual Property in 2006, provides an overview of the history and approaches of numerous PDPs. The chapter is anchored by reports from eight different PDPs and aims toward explaining what potential problems to guard against, what does not work, and—above all what does work—when the public sector plugs into the dynamism of the private sector to try to meet the health and agricultural needs of developing countries. Recognizing that there is no single business model, PDPs employ a common toolbox to manage intellectual property for global health outcomes. It includes defining a discrete territorial market; establishing distinct structures for public sector and private sector markets; determining field of use in a strategic manner; establishing royalty rates to optimize incentives; and providing for access to the developed technology in the event that the research/industry partner abandons the project. Other key areas of discussion, where parallels between PDPs exist, include global-access strategies, pricing issues, the importance of market segmentation, production capacity, strategic early-stage licensing, the IP landscape, and systemic challenges. Collectively, PDPs have broadened the creative understanding of practical ways to resolve the public-policy dilemma of balancing private incentives to generate needed R&D investment with the goal of access to those in need.

Abstract: Because certain patenting and licensing strategies can inhibit the development and dissemination of products for developing countries, intellectual property management strategies need to be developed that can help remove some of these obstacles. It is equally important to apply creative patent management strategies that actively promote access to needed products in developing countries. Care must be taken, however, to ensure that patents on research inputs do not discourage or unreasonably increase the cost for product development that targets needs in small or unprofitable markets. The American Association for the Advancement of Science project on Science and Intellectual Property in the Public Interest convened a working group to explore these issues in 2004. This chapter draws upon the expertise of that group to identify licensing strategies that are effective in promoting humanitarian access to health and agricultural product innovations and expanding their use among poor and disadvantaged groups, particularly in low-income countries. The chapter encourages more public sector IP managers to understand and employ strategies that will achieve these goals and seeks to help private sector licensees to understand the rationale behind and potential benefits of such strategies. Indeed, humanitarian licensing strategies should more and more become the norm by contributing to the development and dissemination of essential medicines and agricultural technologies for developing countries.

Abstract: Freedom to operate (FTO) is—first and foremost—a strategic management tool. It is the synthesis of scientific, legal, and business expertise coupled with strategic planning. Strictly speaking, however, FTO is a legal concept. It is a legal opinion by patent counsel on whether the making, using, selling, or importing of a specified product, in a given geographic market, at a given time, is free from the potential infringement of third-party intellectual property (IP) or tangible property rights. As such, it is one type of input among many that managers use to make strategic risk-management decisions in relation to R&D and product launch. For academic and public research institutions, bringing products to market is often not a main goal. However, as a portion of their research moves downstream into product development, FTO becomes—or should become—an integral component of their endeavors. This is particularly relevant for product-development partnerships (PDPs) in health and for various public–private partnerships (PPPs) in agriculture, as well as for the Consultative Group on International Agricultural Research (CGIAR) and national agricultural research systems (NARS), all of which are concerned about global access.

Research exemptions exist in many jurisdictions, so most university research does not generally need to be concerned with FTO unless product development takes place. But PDPs, such as the Malaria Vaccine Initiative or the TB Alliance, are in a different category since their purpose is directly related to the distribution of products in the developing world. This chapter discusses three main categories of options that are available to reduce risk and obtain a manageable level of FTO. In practice, a combination of two or more options will often be pursued concurrently. These are:

• Legal/IP management strategies: license-in, cross-license, oppose third-party patents, seek nonassert covenant, seek compulsory license
• R&D strategies: modify product, or invent around
• Business strategies: merge and/or acquire, wait and see, abandon project

Each option presents its own risks and opportunities. Any action—including the decision not to take action—carries risk. Delaying the licensing of third-party intellectual property, for example, could lead eventually to expensive licensing terms, the inability to obtain a license, or the possibility of being sued for patent infringement. But for some organizations, such as those developing genetically modified crops, the reverse may be the case. For the public sector, the challenge will be to balance the various types of risks that each option presents.

The chapter concludes by urging the public sector to judiciously evaluate whether and when FTO concerns should be considered, and to build in-house capacity to conduct patent searches and cursory FTO analysis (as opposed to legal opinions). This will lead to benefits like better competitive intelligence and culture change in public sector organizations engaged in product development. An FTO strategy, therefore, is a plan that begins with research and evolves into an attitude throughout a product’s R&D and commercialization/distribution cycle.

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Abstract: An institutional IP (intellectual property) policy forms the very foundation of IP management and, as such, serves as the starting point for a system of institutional best practices. The IP policy should be entirely consistent with the mission of the institution. Whether the role of the institution, as defined by its mission, is primarily disseminator of knowledge through teaching and publication, generator of research, technology transfer engine, or promoter of economic development through education and service and/or through technology transfer, the institutional IP policy should be drafted and enforced in a manner consistent with the mission. Doing so will bring efficiency and clarity to IP management, since all the components of the policy, including IP ownership, patenting, confidentiality, and disclosure can be written into the policy. Moreover, the intellectual property will serve the mission in a way that strengthens the institution’s credibility, reputation, and public image.

Abstract: This chapter provides an introduction to open source software licensing. The chapter seeks to demystify the concept of open source so that intellectual property (IP) owners and managers can decide whether an open source approach is worth pursuing. The chapter explains the principles of free and open source software licensing and outlines the decisions that an innovator must make when deciding which strategy to use for developing a new innovation. Also explained are the differences between open source and public domain, and between the uses of the terms copyleft and academic to describe open source licenses, as well as the incentives (financial and otherwise) for open source licensing. Finally, the author identifies important considerations regarding the possibilities for open source licensing in fields other than software development, particularly biomedicine and agricultural biotechnology.

Abstract: Research tools encompass a wide range of resources, including genes/gene fragments, cell lines, monoclonal antibodies, reagents, animal models, growth factors, combinatorial chemistry and DNA libraries, clones and cloning tools such as polymerase chain reaction, methods, laboratory equipment and machines, databases and computer software. Access to research tools is integral to advancing progress in biotechnological R&D, in both the biomedical and agricultural sciences. However, a complex web of research tool patents has arisen as a result of the revolution in molecular biology and coincident changes in public policy and patent law. These patents can pose a potential block to accessing research tools. For developing countries, several approaches can be formulated and then implemented in order to overcome potential problems associated with research tools. These include changes in patenting policies, research exemptions in patent law to reduce the risk of infringement in R&D, compulsory licensing to allow access to upstream technologies, and institutional adaptations to facilitate access to needed technologies, such as guidelines intended to promote more appropriate behavior by participants in the system. With carefully formulated, multitiered approaches, research tool patenting and licensing (and its possible impact on innovation in health and agricultural research) may be effectively managed.

Abstract: The mission of global health product development partnerships (PDPs) is to develop effective, affordable health products and make them available and affordable to those in need. The not-for-profit product development partnerships (PDPs) often seek for-profit partners to access essential technology, expertise, and resources. These may be early-stage companies, leveraging philanthropic and government resources to develop a platform technology or established companies building out from existing markets or testing new technologies. Such not-for-profit/for-profit partnerships require unique product development and IP (intellectual property) strategies that both recognize the company’s need for commercial benefit and deliver important health products to developing countries.

Abstract: This chapter reviews the options for effective public sector management of intellectual property (IP) in the life sciences, focusing on the need for a judicious, pragmatic choice of options along two axes: (1) deployment of exclusive rights over technology and (2) use of market mechanisms to bring a new technology to the public. The essence of public sector IP management is finding the right settings along these two axes that will deliver tangible outcomes in line with defined public-interest objectives. Experience shows that ex ante assumptions about how to gain optimal leverage from exclusive rights, and the appropriate degree of reliance on market mechanisms, are unlikely to serve a public sector IP manager well. In clarifying objectives and the practical means of achieving them, pragmatic coordination between the practical and policy levels is essential. Public sector IP managers are more likely to be assessed against public interest expectations than their private sector colleagues. In IP management in the life sciences, policy and practice are ultimately two sides of the same coin; practitioners cannot hope, expect, or plan to operate outside the broader policy perspective. Policy-makers therefore need to consider the actual practice of IP management when assessing a policy framework for innovation in the life sciences. IP managers should be open to using legal mechanisms flexibly for inclusion, or exclusion, as required to achieve their goals. Finally, managers should seek mechanisms to pragmatically structure and promote partnerships with those who have the resources necessary to bring life-sciences innovation to the public. Such partnerships may be centered in the public, philanthropic, or private sectors, but more likely fall into a hybrid mix of these categories.

Abstract: An explicit reservation of rights in a commercial technology license can ensure that the licensor’s institutional objectives to support humanitarian applications of its technology are not inadvertently blocked or sidetracked by overly broad terms in the commercial license. Many universities routinely use a reservation of rights to guarantee continued use of licensed technologies within the ongoing research or educational programs of the university. Clauses included in license agreements to reserve rights for humanitarian use of technology are still rare, but awareness is increasing of the utility and importance of such clauses, particularly as philanthropic-research sponsors begin to require grantees to ensure that results and discoveries will be made available for humanitarian purposes. The structure of a clause to reserve rights for humanitarian use ideally both expresses the philosophical intent of the licensee and clearly defines the boundaries of humanitarian use, particularly in relation to commercial use.

Abstract: Recent national and international changes in intellectual property (IP) legislative frameworks are likely to have profound effects on the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. Whereas IP rights are sometimes viewed as creating barriers to access to innovations in health and agriculture, we argue that it is not intellectual property, per se, that raises barriers, but rather how intellectual property is used and managed, particularly by public sector institutions. Above all, we argue that intellectual property is only one of six components of innovation. It is rarely the most important component.

The chapter reviews recent dramatic developments in institutional aspects of intellectual property, as well as global policy shifts and international studies that, among other outcomes, affected the environment for the creation of MIHR and PIPRA. In the field of health, changes have been particularly pronounced with the founding of a new form of institution for innovation: product-development partnerships (PDPs). As a result, we make the case for a fundamental shift in the way in which IP management in health and agricultural innovation is viewed and conducted. In addition, we argue that IP management should be seen as an important element in developing countries’ strategies to become more innovative in addressing diseases of poverty, the alleviation of poverty, and malnutrition. The public sector can employ new ways to achieve its goals within the evolving IP framework. These new ways can help it better mobilize the resources to take a product through the process of innovation. These new ways should include, a) creative licensing practices that ensure global access and affordability, b) improved institutional IP management capabilities, c) the formulation of comprehensive national IP policies, and d) the strengthening of IP court systems and patent offices.

These are what best practices in IP management are all about, and what this Handbook seeks to help bring about and promote.

Abstract: Nonassertion covenants (nonasserts for short) grant permission to third parties to practice a patent they would otherwise infringe. Legally, nonasserts are patent-infringement settlement agreements that are designed and drafted with the purpose of preemptively resolving future infringement disputes. Nonasserts can take three forms: (1) an agreement between two parties, (2) an agreement among several parties, or (3) a public statement. A non-assert can specify the release of only certain patent rights or fields of use, or it can be broad and specify release for entire patent families, including future inventions in a certain area. Public statements effectively place rights to patents, or elements thereof, into the public domain. Nonasserts nevertheless need to specify, precisely, which rights are granted in order to avoid ambiguity that could lead to equitable estoppel.

Nonasserts can have wide-ranging implications in terms of enhancing public sector R&D. One application could be with patent rights covering research tools that are critical for accelerating the development of essential biotechnological applications. Specifically targeted non-asserts can also be effective instruments for industry to permit the use of patented inventions anywhere in the world, provided such use is for the express purposes of addressing specific humanitarian needs in developing countries. This could have broad-ranging and significant positive impact, as this approach reduces transaction costs, encourages innovation to help the poor, and accomplishes this without any loss of commercial opportunities.

Abstract: When public–sector organizations and public–private product development partnerships (PDPs) manage intellectual property (IP), they need to balance the commercial interests of private–sector manufacturers with the public sector’s mission to obtain access to products at the lowest possible cost. An important tool for achieving this balance is the detailed definition of contractual milestones, which should clearly specify the terms for pricing to the public sector, territory and exclusivity, regulatory work, and time to market. Milestones should not, however, be cast in stone. Based on detailed analyses of market conditions, milestones need to remain adjustable throughout the life of the contract. When well defined, milestones can be used to ensure the availability of the most modern healthcare products to the developing world. After all, for the public sector, successful IP management is defined by how many poor people a product will reach, how easily it will be available to them, and who and how many will be able to afford the product. Accordingly, out-licensing intellectual property from public–sector-based organizations to private–sector partners requires the licensor to actively guard public–sector interests.

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