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MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Editor's Summary
As developing countries consider IP management strategies for addressing neglected diseases, the alleviation of poverty, chronic malnutrition, and environmental protection, it will be important to place intellectual property into the broader context of innovation and product development. IP management is but one component of a much larger innovation system. The chapter proposes how, within the rapidly evolving global IP landscape, public sector institutions can better mobilize resources to move a product through the process of innovation. These include:
- Creative licensing practices that ensure global access and affordability
- Improved institutional IP management capabilities
- The formulation of comprehensive national IP policies
- The strengthening of IP court systems and patent offices
Recent national and international changes in IP legislative frameworks already had tremendous effects alreadyand are likely to have even more profound effectson the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. Whereas IP rights are sometimes viewed as creating barriers to access to innovations in health and agriculture, intellectual property, per se, does not raise barriers; rather, it how intellectual property is used and managed, particularly by public sector institutions, that can create obstacle to access.
Seen within the broader context, intellectual property is one of six components of innovation development:
- National health delivery systems, including an attractive, domestic, private sector market for health products
- Manufacturing capability for health products
- The drug and vaccine regulatory system (for safety and efficacy)
- The IP management system
- R&D capability by the public and private sectors
- International trade systems for health products, including global procurement funds
Within the context of these six components of innovation, intellectual property fits into, and indeed is interwoven, into the entire scheme. However, what is missing is an overall architecture for global health innovation, whereby the various components, of which intellectual property is one, are fit into a larger structure, that is, a global model for health and agricultural innovation.
And that is where this chapter raises critical issues and makes significant proposals, framing IP management within the global context, wherein the developed and developing countries and the public and private sectors all exist, operate and interact amongst each other. This is a trend that is inexorably advancing
in parallel with the globalization. Because of the increasing interaction between developed and developing economies and the increased number and complexity of relationships between the public and private sectors, the need for understanding how these various partnerships can be optimally forged and maximally utilized increases day by day.
The chapter reviews recent dramatic developments in institutional aspects of intellectual property, as well as global policy shifts and international studies. In the field of health, changes have been particularly pronounced with the founding of a new form of institution for innovation: product-development partnerships (PDPs). As a result, we make the case for a fundamental shift in the way in which IP management in health and agricultural innovation is viewed and conducted. The public sector can employ new ways to achieve its goals within the evolving IP framework. In response to rapid global evolution, non-governmental organizations (NGOs) and PDPs will have increasingly important roles to play in the global IP environment, particularly for developing countries. However, arguments (some legitimate, some not well-founded) for and against intellectual property abound. For example, some argue that large pharmaceutical and agricultural companies control intellectual property and use the power of IP rights to capture markets, limit consumer choice in both health and agriculture, and raise prices.
Still, it is well established that intellectual property advances product development because it provides incentives for R&D, commercialization and product distribution. Investors in biotechnological R&D naturally want to protect their investments; they must, therefore, secure IP rights for their inventions. Historically, the private sector had no incentive to create safe and efficacious pharmaceuticals until the creation of IP rights protection. Furthermore, the public sector had neither the requisite funds nor the capability to develop products. Yet, as the public sector devotes more of its efforts to humanitarian missions, and engages in more development partnerships (such as PDPs) in the fields of health and agriculture, it too will need to consider the critical role of intellectual property in this process. And this ought to be within the broader innovation context.
As a concrete example of how these best practices in IP management can be implemented, the chapter discusses how PDPs are playing an increasingly critical role in coordinating the resources, and expertise, necessary for product development and delivery to developing countries. In order to do this, PDPs have recognized that if they indeed want to collaborate with the private sector to develop new, valuable health technologies, they must seriously address IP issues. Nearly all PDPs have now come to accept that IP management is essential for advancing their respective missions, which all have one thing in common: accelerating access to essential innovations in health to developing countries.
Intellectual property is here to stay. If the public sector does not effectively utilize the IP system, it will neither be serving its own interests nor the interests of those it has promised to serve. If it does not know how to effectively manage intellectual property, the public sector risks squandering the rights, powers, and opportunities that the revised IP system provides. Intellectual property is a tool, and, like all tools, its impact depends on how it is used, by whom, and for what purpose. IP tools can be used to restrict access to innovations or ensure that everyone has access to them. As this chapter points out, its all a matter of capacity, management and
context.
For IP management to efficiently function in the broader context of innovation, there needs to be documentation of best practices. This is what the Handbook seeks to do: a teaching and capacity building resource for best practices in IP management, with a focus on health and agricultural biotechnologies for the poor in developing countries. When it comes to increasing developing countries access to fundamental innovations in health and agriculture, success requires knowledge, capacity and active engagement. These are what best practices in IP management are all about and what the Handbook seeks to promote.
Key Implications and Best Practices
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.
For Government Policymakers
- There are essentially five strategic options for public sector institutions to deal with intellectual property. First, they can use IP in the way companies do. This is neither necessary nor appropriate. Second, the entire IP rights system can be changed. This is unlikely to happen. Third, one can wait for the IP rights system to be improved, both through international agreements and national law. Such changes are constantly in progress. Fourth, public sector institutions can ignore intellectual property aspects. This limits their effectiveness tremendously. And finally the fifth option is to use intellectual property constructively in a way that furthers the regional and national economic development objectives while concurrently addressing pressing humanitarian needs. How to adapt the fifth approach to the particular institutional context is what this Handbook and best practices are all about.
- Recent national and international changes in IP legislative frameworks have already had profound on the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. These changes demands public sector institutions to adapt quickly to the changing environments in which they operate and this can place a tremendous demands on them. In this context, reviewing and re-defining, as appropriate, their IP policies and IP strategies may be essential and constitute a useful way to further their public sector missions.
- As countries increasingly integrate their innovation system, the trend to have national IP laws and policies harmonized and in accordance with international treaties will continue. Within this framework, national governments have a lot of flexibility to tailor-make their policies in response to national needs and priorities.
- Innovation is a complex process. It is stimulated by coordinated and structured polices and programs. One specific strategy to increase the potential is through public-private product-development partnerships.
For Senior Management (university president, R&D manager, etc)
- Recent national and international changes in IP legislative frameworks have already had profound on the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. These changes demands public sector institutions to adapt quickly to the changing environments in which they operate and this can place a tremendous demands on them. In this context, reviewing and re-defining, as appropriate, their IP policies and IP strategies may be essential and constitute a useful way to further their public sector missions.
- The management of intellectual property should be seen as one part of the larger process of innovation and product development.
- It is important for an institute to ensure that it is following best practices in IP management if it wishes to collaborate with partners from various sectors (for example, public- and private-sector entities) and localities (for example, developing and developed countries). An institute that follows best practices, and demonstrates their implementation, indicates that it has a credible knowledge base, a dedication to building trust, and a commitment to agreements.
- There are essentially five strategic options for public sector institutions to deal with intellectual property. First, they can use IP in the way companies do. This is neither necessary nor appropriate. Second, the entire IP rights system can be changed. This is unlikely to happen. Third, one can wait for the IP rights system to be improved, both through international agreements and national law. Such changes are constantly in progress. Fourth, public sector institutions can ignore intellectual property aspects. This limits their effectiveness tremendously. And finally the fifth option is to use intellectual property constructively in a way that furthers the regional and national economic development objectives while concurrently addressing pressing humanitarian needs. How to adapt the fifth approach to the particular institutional context is what this Handbook and best practices are all about.
For Scientists
- There are essentially five strategic options for public sector institutions to deal with intellectual property. First, they can use IP in the way companies do. This is neither necessary nor appropriate. Second, the entire IP rights system can be changed. This is unlikely to happen. Third, one can wait for the IP rights system to be improved, both through international agreements and national law. Such changes are constantly in progress. Fourth, public sector institutions can ignore intellectual property aspects. This limits their effectiveness tremendously. And finally the fifth option is to use intellectual property constructively in a way that furthers the regional and national economic development objectives while concurrently addressing pressing humanitarian needs. How to adapt the fifth approach to the particular institutional context is what this Handbook and best practices are all about.
- Recent national and international changes in IP legislative frameworks have already had profound on the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. These changes demands public sector institutions to adapt quickly to the changing environments in which they operate and this can place a tremendous demands on them. In this context, reviewing and re-defining, as appropriate, their IP policies and IP strategies may be essential and constitute a useful way to further their public sector missions. Your role in this process is critical.
- Your work is part of a larger innovation process. Recognize that your research can be valuable in many different contexts and practical applications and that your power to influence how your inventions are put to use for both economic and humanitarian objectives is substantial.
For Technology Transfer Officers
- There are essentially five strategic options for public sector institutions to deal with intellectual property. First, they can use IP in the way companies do. This is neither necessary nor appropriate. Second, the entire IP rights system can be changed. This is unlikely to happen. Third, one can wait for the IP rights system to be improved, both through international agreements and national law. Such changes are constantly in progress. Fourth, public sector institutions can ignore intellectual property aspects. This limits their effectiveness tremendously. And finally the fifth option is to use intellectual property constructively in a way that furthers the regional and national economic development objectives while concurrently addressing pressing humanitarian needs. How to adapt the fifth approach to the particular institutional context is what this Handbook and best practices are all about.
- Recent national and international changes in IP legislative frameworks have already had profound on the ways in which health and agricultural innovations reach the poor and on how public and private research and development institutions pursue their work. These changes demands public sector institutions to adapt quickly to the changing environments in which they operate and this can place a tremendous demands on them. In this context, reviewing and re-defining, as appropriate, their IP policies and IP strategies may be essential and constitute a useful way to further their public sector missions. Your role in this process is critical.
- IP management is important, but it is not the only duty of a technology transfer office. An office ought to engage in creative licensing practices, optimize its IP management capacity (at both the human and institutional levels), and be willing to create, expand, and cultivate networks with professionals from around the world.
Krattiger A, RT Mahoney, L Nelsen, JA Thomson, AB Bennett, K Satyanarayana, GD Graff, C Fernandez and SP Kowalski. 2007. Editors Summary, Implications and Best Practices (Chapter 1.1). From the online version of Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices. MIHR: Oxford, U.K., and PIPRA: Davis, U.S.A. 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.
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