Institutional Policies and Strategies

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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: Several factors help to establish who owns a university invention and what rights the university may, or may not, have. These factors include whether (1) there are express or implied agreements to assign ownership, (2) the inventor is employed by the university, (3) the invention was made within the scope of employment, and (4) where and when the invention was made. Under U.S. law, individuals own their inventions, except where there is an express agreement providing for assignment of ownership of inventions to an employer or where an implied agreement to assign is found because the employee was hired or assigned to invent or solve a specific problem or served the employer in a fiduciary capacity. Therefore, in addition to implementing clearly delineated policies, it is critically important for a university to absolutely require all employees and visitors to sign invention assignment agreements (IAAs) on their date of arrival. It is unwise to rely on policy statements to determine whether or not a university employee owns his or her invention: universities should always obtain signed (express) agreements, and both the employee and the technology transfer office should retain copies. Research contracts with the government and other sponsors should have a checklist item on the existence of IAAs for the principal investigator and other researchers (whether or not a university should have undergraduates routinely sign IAAs is up to each university). Upon termination of employment, personnel should be asked to sign an exit form indicating that they have disclosed all inventions falling within the terms of the IAA to the university licensing office.

Abstract: Without inventors, there would be no technology to transfer. But without technology transfer professionals, there would be limited transfer of technology. Good relations between inventors and technology transfer professionals are therefore essential for the commercialization enterprise to succeed. Relationships should be established long before the transfer services of the technology transfer office (TTO) are required. A healthy relationship will allow technology managers to negotiate both faculty and business concerns about licensing agreements. Making sure that the inventor is sympathetic to the aims of the TTO will also make it much easier for everyone to understand how a technology may meet market needs, recognize potential licenses, and determine whether a licensee is fulfilling its obligations. For all of these reasons and more, a TTO should always go the extra mile to educate, develop, and maintain good working relationships with inventors.

Abstract: This chapter explains how important it is for a research institute to audit both the intellectual property (IP) that it generates and the third party IP that its researchers utilize. Such an audit will have the practical consequence of enabling the research institute (when appropriate) to secure ownership, maintain, and manage the IP for which it is responsible.

Abstract: The potential for personal interests to influence institutional decisions in universities and public sector research institutions continues to grow. This is because of the increasing activity in intellectual property (IP) management and technology transfer undertaken by these institutions. The activities have the potential to generate both personal and institutional financial gain, making conflict of interest and conflict of commitment issues unavoidable. This chapter explains the nature of these conflicts and discusses the policies, regarding conflict of interest, of several universities, offering them as potential models for crafting these indispensable policies.

Abstract: This chapter describes the structure, policies, and operations of the Technology Licensing Office at the Massachusetts Institute of Technology (M.I.T.). The chapter emphasizes the licensing office’s role in generating spinout companies and considers the importance of the biotechnology cluster within the state of Massachusetts and it’s surrounding regions. Also discussed is M.I.T.’s approach to ensuring that licensing procedures maximize access to medicines and vaccines arising from M.I.T.’s research.

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: Governments at all levels are showing great interest—and some are spending lots of money—in developing research clusters that they hope will benefit their local and national economies. Clusters are complex, however, and this chapter aims to help policy-makers maximize their benefits. The chapter offers a taxonomy of countries and their potential for cluster development and explains a five-stage process for realistic cluster building. Stage one assesses capacities, resources, and opportunities. Stage two involves choosing an anchor strategy. In stage three, organizational and institutional leaders are identified to take the lead in developing the cluster. In stage four, proactive tactics are chosen. Stage five identifies the cluster’s lifecycle and the strategies needed to sustain it. Cluster building is knowledge-based development, which is inherently different from traditional industrial development. For one thing, cluster building requires global links. Companies and skilled employees are less interested in fiscal incentives, public infrastructure, or other government support than in the innovation community and its networks.

Abstract: This chapter is about university spinouts: why they are created, who founds them, and how they are developed. It also considers many of the issues that a university and its faculty have to address to successfully launch and develop new for-profit ventures. Spinouts carry risks, but they may also be the best vehicle for developing early-stage university technologies and providing a host of other benefits. The chapter offers examples from the past five years at Yale University, as well as from the private sector, that suggest ways to minimize the risks and maximize benefits.

Abstract: This chapter provides a practical guide for organizations seeking to transfer their intellectual property (IP) rights to a spinout company (normally through a licensing agreement) so that the company can convert the IP into products or services that benefit the public. Based on experiences at Stanford University over the past three decades, key issues have been identified for negotiating transfer to a spinout, and guidance on best practices for reaching a successful agreement is provided. The chapter briefly reviews potential conflict-of-interest and conflict-of-commitment issues that inevitability arise when employees of public research organizations become involved in spinout companies.

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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: Business incubators, as economic tools, have become increasingly common in the last decade and a half for stimulating local development. Incubators provide facilities and services (for example, business planning and legal, accounting, and marketing support) to catalyze small-business growth. In fact, incubated companies have a dramatically higher rate of survival than an average spinout does. This chapter explains what steps to take to set up an incubator, including the basic structure and the kinds of services generally offered. Successful incubator programs are discussed, and a helpful bibliography focused on case studies is provided.

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.

Abstract: Public sector institutions help deliver public health goods. By extension, universities that receive public research funds must deliver a benefit to the public that goes beyond licensing a discovery to the private sector for development. In the United States, 25 years of experience with the Bayh-Dole Act, which governs the use of intellectual property (IP) derived from public research, offers both lessons and warnings for developing countries currently establishing their own IP systems. Bayh-Dole successfully created a large body of IP from publicly funded research. Absent a strong profit motive for the private sector, however, the Act has been much less successful at producing public goods for health. Current practice undervalues the “public benefit” aspect of the mandate, especially for the poor. Possible ways to address this mandate would be for public sector entities (and their academic partners in the biomedical sciences) to invest some of their earnings from licensing publicly funded discoveries into programs for neglected diseases of the poor. IP rights from public funded research could also be leveraged in negotiating licensing agreements with the private sector to address these neglected diseases. IP laws and institutions should be designed to encourage such sharing. The public and academic research sectors should also seek a new compact with the private sector aimed at reducing the burden of disease affecting the poor.

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: A laboratory notebook is an important tool that goes well beyond research management and can have important implications for issues ranging from intellectual property management to the prevention of fraud. This chapter discusses the key elements of a laboratory notebook, types of notebooks, what should be included in the notebook, ownership issues, archiving, and security. The chapter provides sample notebook pages that illustrate some of the recommended practices.

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 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: 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: 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: Technology transfer is a rewarding process for the university, researchers, students, the business community, the public, and the professionals who make it all happen. Technology transfer brings new products, services, and jobs. But it is a complex process, one that requires sustained dedication at every level. This chapter offers advice about some of the most important policy and strategy issues: five are economic issues and five relate to implementation. The chapter concludes with a discussion of technology transfer pitfalls caused by unrealistic expectations. The chapter emphasizes the role of senior management in changing the IP (intellectual property) culture, the need for transparent conflict-of-interest policies, and the importance of sufficient autonomy and infrastructure support for technology transfer officers.