Institutional Policies and Strategies
Summary and Overview
Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. 5: Institutional Policies and Strategies. In Executive Guide to Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (Krattiger A, RT Mahoney, L Nelsen et al.). MIHR (Oxford, UK), PIPRA (Davis, USA), Oswaldo Cruz Foundation (Fiocruz, Rio de Janeiro, Brazil), and bioDevelopments-International Institute (Ithaca, USA). Available online at www.ipHandbook.org.
© 2007. A Krattiger et al. Sharing the Art of IP Management: Photocopying and distribution through the Internet for noncommercial purposes is permitted and encouraged.
The boundaries of any property must be clear. As a farmer needs to know where his or her field begins and ends, an innovator must know exactly the definition of his or her invention. But it is more difficult by far to delineate where rights to something intangible begin and end. In addition, intangible assets can be difficult to keep track of, to share, and to use. Yet in a research-and-development environment, intangible assets are often the most valuable and important ones. How then, can they be leveraged to reinforce the mission of an institution? How can the specific objectives be achieved more effectively and efficiently through the incorporation of best practices in IP (intellectual property) management? What are these principles and practices? And how does an IP policy relate to an operational IP strategy?
This section offers insights into achieving and maintaining clarity about the ownership of intellectual property in public sector institutions and stresses the value of IP strategies and IP policies. These are important for achieving success and have been increasingly encouraged—or required—by certain donors as a strategy to ensure global access. Global access, especially by the poor, and ownership of intellectual property go hand in hand. Indeed, the most important aspect of IP protection is that it bestows control over intellectual assets. If an organization—especially a public institution—fails to obtain IP rights for its inventions, it risks losing control over them. Failure to maintain rights may result in private entities appropriating elements of the value without major regard to the mission of public institutions, or it could lead to the intellectual assets becoming useless due to lack of further investment and development. This is the most important reason why the public sector should take IP management more seriously than it traditionally has. IP management is a fundamental element in the public sector’s strategy of putting intellectual property to work for the public good.
Appropriately, the first chapter in this section of the Handbook is a comprehensive discussion on IP strategy by Pitkethly.1 His definition of strategy relevant to IP management is:
- the formulation and adoption of courses of action enabling the reaching of long-term goals and objectives of an institution
- the allocation of resources (financial and human) necessary for carrying out these actions
By extension, IP strategy is an integral part of an overall business strategy that uses IP rights to manage technology.
Pitkethly begins by mapping out how IP rights systems fulfill four purposes:
- providing incentives for innovation
- allowing for the packaging of intellectual assets into innovative processes
- encouraging the diffusion of technical information
- enabling the capturing of added value (economic and/or humanitarian) through the control of intellectual assets
Viewed in this way, IP rights systems can be instrumental in enabling the diffusion of technological information. For example, patent specifications provide detailed embodiments of inventions, which are available for all to see. Using the Internet, these records can be accessed for free anywhere in the world. This availability of and access to information greatly facilitates innovation, since others will be able to work to improve or invent around the disclosed patented invention. Patents can also be useful sources of information for scientists, since the patent application may be the first and only publication about a competing innovation.
Organizations should have both external and internal IP strategies. Broadly speaking, this is referred to as litigation, licensing, and learning.
An external IP strategy involves exploiting inventions (by developing them in-house, selling them, or licensing them). Litigation denies IP rights to others; licensing allows rights to others. Learning can be a part of technology out-licensing, since it not only gives others access to these technologies but also provides learning opportunities for the organization. This strategy is especially effective if an institution’s aim is to diffuse technology as widely as possible and ensure global access.
As a result, donors are increasingly requiring grantees to take IP management seriously. Ballantyne and Nelki2 of the Wellcome Trust (the Trust) in the United Kingdom, a major charitable funder of biomedical research, is one such pioneering funding entity. The Trust requires institutions that have produced intellectual property using the Trust grants to determine whether the public will benefit from the protection of that property and whether all participants in the process receive proceeds proportional to the amount of money, equipment, knowledge, or labor they contributed. But above all, the Trust insists that intellectual property arising from its grant awards be adequately exploited; the Trust does not shy away from taking over activities if grantees fail to adequately exploit the intellectual property. The chapter ends with a series of case studies that illustrate the practical aspects of IP strategies.3
Grantees more and more frequently will need to present IP management strategies as part of their proposals. In the case of the Bill and Melinda Gates Foundation, certain grantees are required global access strategies4 that outline how recipients will manage new and existing intellectual property. Certain minimum standards may also be required, such as:
- keeping the research field open by prohibiting any licensee from enforcing intellectual property against universities and research institutions that carry out noncommercial activities
- retaining licensable research rights to any invention developed with donor funding
- obtaining freedom to operate for all background intellectual property owned by collaborating institutions
- ensuring good IP management, which includes exploitation of intellectual property, with the goal of ensuring its use in developing countries
Some granting agencies also require prospective grantees to explicitly state their IP policies. Kowalski5 reviews and discusses several institutions’ policies and concludes that, at a minimum, an IP policy should define IP ownership, outline the patenting policy, describe the manner in which an institution will handle confidential information, set out the principles of its IP licensing and marketing approaches, explain how income arising from intellectual property will be distributed, and delineate the rights and obligations of inventors and the institution, as well as any rights the institution will retain (such as for research and for humanitarian uses).
Any new or revised IP policy (and IP strategy) will have to be “sold” to people both inside and outside an institution. It is important to explain what the policy contains and why the policy is designed the way it is. And perhaps staff at multiple levels should be involved in developing and revising, as needed, the IP policy. This group will be able to have extensive discussions about the role and function of intellectual property in the organization. These discussions will be an effective mechanism for building capacity and staff support of the policy. Some of the most controversial issues can be resolved before they become an obstacle, such as: Who owns what? Who benefits and how?
These sometimes-troublesome questions are discussed by Weidemier,6 who reviews how universities in the United States are handling these aspects. Her chapter examines eight possible cases that illustrate and clarify the somewhat abstract principles of ownership of university inventions and are followed by a series of hypothetical scenarios. Weidemier, among others, concludes that universities should require all employees and visitors to sign invention assignment agreements on their date of arrival. Neither an employee handbook that discusses patent assignment nor a published university patent policy may be enough to ensure that the university is assigned ownership.
With the assignment of ownership rights to an employer comes the duty to disclose that an invention has been made. Indeed, an inventor is responsible for and has much to gain by making timely disclosures of his or her invention to the technology transfer office (TTO), the first step in enabling technology transfer. Di Sante7 points out that successful commercialization is built on a foundation of good relations between inventors and technology transfer professionals. Such relationships should be established long before the transfer services of the technology transfer office are required, since this will enable technology managers to negotiate both faculty and business concerns about licensing agreements whenever the opportunity arises. The role of the inventor in the entire IP protection and IP licensing/transfer process cannot be overstated and should continue throughout the life of the technology.8 For example, years after a patent has been licensed, the inventor may be the best-placed person to alert a TTO that a certain product being sold may infringe the patent.
But dealing with inventors is not always easy.9 Inventors are prone to fall in love with their own creations, and, perhaps unreasonably, anticipate that theirs is the next great thing. It is the technology transfer professional’s responsibility to tactfully ensure that the inventors’ expectations are kept in line with reality.
Establishing good relationships with inventors is an important way to identify the intellectual property being generated in the research institution. But from an institutional point of view, a more comprehensive perspective on intellectual property is often warranted. This applies particularly to times when an organization develops a strategic plan or IP management strategy. In this context, IP audits can be essential and often form the basis for an internal review and a revision of IP strategy. Blakeney10 provides a comprehensive overview of IP audits. Indeed, the importance of IP audits is becoming more and more apparent, in the private sector as well as in the public sector, as public entities increasingly deal with other parties’ intellectual property.
An IP audit seeks to accomplish three broad objectives for an institution. First, it seeks to identify the intellectual property generated by its researchers. This intellectual property is an asset, with value that an institution ought to identify, assess, and manage. Second, an audit seeks to identify and review the management of third-party intellectual property as a way of avoiding liability for misuse. The IP audit is thus a systematic, methodical identification of the intellectual property within the institute.11 As the chapter shows, the audit follows a procedure, from start to finish, so that at the audit’s conclusion senior managers are able to frame and implement good IP management practices. This is the third broad objective of an IP audit: to contribute to the formulation and execution of the IP policy and IP strategy.
From a practical point of view, an IP audit reviews a number of existing practices and establishes the context in which intellectual property is being handled. For example, a research institute’s ownership and control over any intellectual property will depend on its legal status as an entity. An IP auditor will review the incorporation documents to identify what powers the institute has to own and to deal with intellectual property. For universities and government institutions, such a review will also include the prevailing government policies.
The IP auditors will also scrutinize the IP policy of the institute, if indeed there is a policy. It should ask questions, such as: Where is it posted? What does it say? Are new employees required to read it? IP audits may also uncover potential conflicts of interest. Bennett12 offers a primer on issues related to the management of conflict of interest and conflict of commitment. Conflict of interest occurs when the financial interests of an institution’s researchers are incompatible with the institution’s mission, policy, or goals. Conflict of commitment may arise when the time a researcher spends in external activities related to, for example, downstream technology development, interferes with his or her attention to duties to the institution (for example, teaching or extension responsibilities).
While conflicts of interest should not be seen in a negative light, making exceptions to the rules is both dangerous and potentially harmful. Someone with a potential conflict of interest is not guilty of anything; rather, he or she may actually be a more valuable “asset” because of the potential conflict. This applies most strikingly when a professor has an interest in forming a spinout company based on university research. Potentially, larger issues will arise due to undisclosed conflicts of interest. What a university needs is to define a clear chain of command and in rare circumstances to establish oversight committees. Committees tend to slow the process with significant delays in time, which typically makes the process unmanageable and useless.
Most conflicts arise when potential conflicts are not disclosed. Conversely, a major tactic in managing conflict of interest is to disclose potential conflicts. And most conflicts of interest can be managed fairly easily provided the policy is clear and precise. M.I.T., for example, manages an unusually large number of spinouts and, therefore, has a very strict conflict of interest policy (this is discussed by Nelsen13). A technology transfer officer’s role is to creatively craft arrangements within the rules, not to use these rules as deterrents. Put differently, Nelsen describes M.I.T.’s operating motto: “A firm wall between university and industry—but a wall with many doors… In sum, technology transfer inevitably brings conflicts of interest. The challenge is to manage them.”14
Endnotes
1 Chapter 5.1 by R Pitkethly titled IP Strategy, p. 459.
2 Chapter 5.2 by Z Ballantyne and D Nelki titled Management Policy: A Donor’s Perspective, p. 475.
3 The following are reviewed in detail: the development of a typhoid vaccine, malaria drugs, the single nucleotide polymorphisms (SNP) consortium, and the International HapMap Project.
4 For an example of how global access strategies can be incorporated into product development partnerships and vaccine development, see Mahoney RT, A Krattiger, JD Clemens and R Curtiss III. 2007. The Introduction of New Vaccines into Developing Countries IV: Global Access Strategies. Vaccine 25(2007): 4003–4011.
5 Chapter 5.3 by SP Kowalski titled Making the Most of Intellectual Property: Developing an Institutional IP Policy, p. 485.
6 Chapter 5.4 by BJ Weidemier titled Ownership of University Inventions: Practical Considerations, p. 495.
7 Chapter 5.5 by AC Di Sante titled The Role of the Inventor in the Technology Transfer Process, p. 507.
8 An important exception to this is licensing. A TTO officer typically would not have the inventor participate during negotiations with potential licensees, although rare exceptions may apply.
9 See also Section 8 dealing more exhaustively with inventions and inventors.
10 Chapter 5.6 by M Blakeney titled Conducting IP Audits, p. 515.
11 This may include: patentable biological assets, such as germplasm resources, DNA libraries and enabling technologies (marker genes, probes); technological know-how; confidential information; patents, utility models and industrial design rights in equipment; copyrighted information (database rights, computer programs, and databases); publications; CD-ROMs; video materials; online materials; trademarks; and more.
12 Chapter 5.7 by AB Bennett titled Conflict of Interest and Conflict of Commitment Management in Technology Transfer, p. 527.
13 See Box 1 for M.I.T.’s policy (Chapter 3.13 by L Nelsen titled The Activities and Roles of M.I.T. in Forming Clusters and Strengthening Entrepreneurship, p. 309).
14 Chapter 6.1 by L Nelsen titled Ten Things Heads of Institutions Should Know about Setting Up a Technology Transfer Office, p. 537.
 Abstract
Conducting IP Audits
by Michael Blakeney
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
Conflict of Interest and Conflict of Commitment Management in Technology Transfer
by Alan B. Bennett
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
IP Management Policy: A Donor’s Perspective
by Zoë Ballantyne, Daniel Nelki
Abstract
IP Strategy
by Robert Pitkethly
Abstract
Making the Most of Intellectual Property: Developing an Institutional IP Policy
by Stanley P. Kowalski
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
Ownership of University Inventions: Practical Considerations
by B. Jean Weidemier
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
The Role of the Inventor in the Technology Transfer Process
by Anne C. Di Sante
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
The Activities and Roles of M.I.T. in Forming Clusters and Strengthening Entrepreneurship
by Lita Nelsen
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
The African Agricultural Technology Foundation Approach to IP Management
by Richard Y. Boadi, Mpoko Bokanga
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
Application and Examples of Best Practices in IP Management: The Donald Danforth Plant Science Center
by Karel R. Schubert
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
Building Research Clusters: Exploring Public Policy Options for Supporting Regional Innovation
by Peter W. B. Phillips, Camille D. Ryan
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
Creating and Developing Spinouts: Experiences from Yale University and Beyond
by Alfred (Buz) Brown, Jon Soderstrom
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
Dealing with Spinout Companies
by Jon C. Sandelin
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.
Abstract
Echoes of Bayh-Dole? A Survey of IP and Technology Transfer Policies in Emerging and Developing Economies
by Gregory D. Graff
Abstract
Ensuring Developing-Country Access to New Inventions: The Role of Patents and the Power of Public Sector Research Institutions
by Lita Nelsen, Anatole Krattiger
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
Ensuring Global Access through Effective IP Management: Strategies of Product-Development Partnerships
by Robert Eiss, Kathi E. Hanna, Richard T. Mahoney
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
Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation
by Amanda L. Brewster, Stephen A. Hansen, Audrey R. Chapman
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
Formation of a Business Incubator
by Edward M. Zablocki
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, Public Sector Research, and Product-Development Partnerships: Strategies and Risk-Management Options
by Anatole Krattiger
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
Global Health: Lessons from Bayh-Dole
by Rachel A. Nugent, Gerald T. Keusch
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
How Public–Private Partnerships Handle Intellectual Property: The PATH Experience
by Steve Brooke, Claudia M. Harner-Jay, Heidi Lasher, Erica Jacoby
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
How to Start–and Keep–a Laboratory Notebook: Policy and Practical Guidelines
by Jennifer A. Thomson
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
A Model for the Collaborative Development of Agricultural Biotechnology Products in Chile
by Carlos Fernandez, Michael R. Moynihan
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
The New American University and the Role of “Technology Translation”: The Approach of Arizona State University
by Peter J. Slate
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
Partnerships for Innovation and Global Health: NIH International Technology Transfer Activities
by Luis A. Salicrup, Mark L. Rohrbaugh
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
Patent Consolidation and Equitable Access: PATH’s Malaria Vaccines
by Sandra L. Shotwell
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
Product Development and IP Strategies for Global Health Product Development Partnerships
by Sandra L. Shotwell
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
Reservation of Rights for Humanitarian Uses
by Alan B. Bennett
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
Technology Transfer at the University of California
by Alan B. Bennett, Michael Carriere
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
Ten Things Heads of Institutions Should Know about Setting Up a Technology Transfer Office
by Lita Nelsen
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.
|
Printer Friendly
Download PDF
Show All Abstracts