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Your source for expert commentary on IP management issues.
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About
Editor-in-Chief, Anatole Krattiger
Editorial Board
Concept Foundation
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Why This Topic Is Important
This section highlights for the senior administrator a range of specific strategies and mechanisms that are
being employed by research institutions to facilitate access to new technologies. These include both
contract-based approaches and organizational approaches. An institution can adopt these practices, and
even build them into its policies. It can also collaborate with organizations or build new organizations that
embody these approaches.
Key Implications and Best Practices: Section 2
Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.
- One of the benefits of enabling public research institutions to own IP rights is that institutions can control how technology is deployed through the terms of licensing contracts, thus meeting both commercial and noncommercial goals.
- Well-crafted contracts based on best practices can be instrumental in achieving global access, provided the entire innovation process is given due consideration from the outset. This includes consideration of R&D capabilities, regulatory environment, manufacturing, IP management, access to markets, and trade-related concerns. Such an approach requires a lot of preparation and detailed knowledge of the processes related to developing a mission-driven mindset to establish optimum goals for the public sector.
- One of the central elements for public sector institutions is to have explicit IP policies and demonstrated institutional capacity to implement best practices in IP management. Any licensor, public or private, is more willing to license to institutions that proactively protect third-party property, which leads to confidence building and a higher degree of motivation to proceed with more licensing and technology transfer arrangements.
- Humanitarian licensing can benefit both the research and public service missions of a university or public sector research institution. Consider creating an institutional policy that standardizes the reservation of humanitarian rights on all technologies, including, as appropriate, the right to practice the invention for nonprofit goals. Potential licensees are less likely to resist if they know that the terms being requested are “standard” and part of the deal in doing business with an institution.
- Implementing the various best practices discussed and presented in this section is complex and requires experience. Public sector institutions need to plan and implement focused capacity building in IP management.
- Networks with individuals and organizations, such as foreign universities, corporations, product development partnerships (PDPs), and government agencies, should be seen as critical elements that enhance the innovative potential of any institution.
- Indeed, partnerships are an important way to fill in the capacities that are required to make an institution innovative. Few, if any, institutions have the entire range of capacities to bring ideas to market.
- Under many circumstances, patenting may be unnecessary and publication might offer the widest dissemination. The decision to place inventions in the public domain should be calculated and made on a case-by-case basis. open source licensing might be another complementary component of an IP management strategy.
- Whenever possible, consider nonexclusive licensing as a strategy to maximize the utilization of research tools. On product patents, exclusive licensing may, in many circumstances, be more effective to reach broad dissemination, particularly if coupled with strong milestone clauses.
- Complementary strategies are the segmenting or apportioning of markets, whereby different licensees obtain exclusivity but only for one portion of the field of use. This strategy can also be used to implement tiered pricing.
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 Assembly of and Access to Intellectual Property: Focus on Patent Pools and a Review of Other Mechanisms
by Anatole Krattiger, Stanley P. Kowalski
Abstract:
This chapter reviews different forms of IP (intellectual property) “assembly” mechanisms (royalty-collection agencies, information clearinghouses, technology clearinghouses, open-source innovation clearinghouses, honest brokers, and other forms of facilitators, IP management services, IP commercialization agents, the services of merchant banks and venture capital enterprises, and patent pools). Emphasis is placed on patent pools, which are voluntary agreements between two or more patent owners to license one or more of their patents to one another or to third parties. Although there are many forms of patent pools, such arrangements fundamentally consist of the interchange (cross-licensing) of rights to essential patents by a number of entities, as well as an agreed framework for out-licensing the pooled intellectual property to each other and/or to third parties, including an agreed-pricing and royalty-sharing scheme.
There are both benefits and risks associated with patent pools. Benefits include greater ease with respect to resolving patent conflicts, making assembled patents in the pool available to others, and resolving disputes over blocking patents. Risks include antitrust liability. Under certain circumstances, patent pools have application in the area of humanitarian licensing as instruments of assembly of intellectual property.
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
Open Source Licensing
by Janet Hope
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
Patenting and Licensing Research Tools
by Charles Clift
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
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
Using Milestones in Healthcare Product Licensing Deals to Ensure Access in Developing Countries
by Joachim Oehler
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.
Abstract
Valuation and Licensing in Global Health
by Ashley J. Stevens
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