Search
advanced search
search help
ipHandbook Blog
Your source for expert commentary on IP management issues.
Go to the blog
In ipHandbook Forums
See recent topics
About
Editor-in-Chief, Anatole Krattiger
Editorial Board
Concept Foundation
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
|
Why This Topic Is Important
This section highlights for policymakers a range of specific strategies and mechanisms that are being
employed to facilitate access to new technologies. These include both contract-based approaches and
organizational approaches. Policies could be crafted to facilitate such strategies and mechanisms or
could build upon the basic principles that they embody.
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 capabilities, 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 and marketing the invention; realistic forecasting of product potential; persistence in quantitative forecasting and establishing a master plan for the entire product rollout; and a mission-driven mindset to establish optimum goals for the public sector.
- One of many components of best practices by the public sector is incorporating humanitarian-use reservation provisions in commercial licensing contracts. This is becoming increasingly common with certain universities around the world, particularly with respect to agricultural inventions. There is conceptually no reason why this should not become common practice globally.
- Public sector institutions should have explicit IP policies and demonstrated institutional capacity to implement best practices in IP management. Any licensor, public or private, is more willing to give licenses 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.
- Open source may offer an alternative mechanism for facilitating access to innovations in health and agriculture, provided the open-source approaches that are so popular and effective in the software area can be successfully adapted to the biological sciences. More conceptual research is needed to make open source an effective way to accelerate innovation in health and agriculture.
- Other policies and laws can foster and enable efficient IP assembly (or in-licensing by national institutions to obtain freedom to operate and the freedom to license bundles of technologies to manufacturers). These may include patent pools and other mechanisms.
 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
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.
|
|
Printer Friendly
Show All Abstracts