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About
MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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Why This Topic Is Important
This section provides the innovative researcher with an over-arching vision of how intellectual property
management and the process of technology transfer can turn new ideas and discoveries into real-world
solutions that can drive economic growth, alleviate poverty, overcome malnutrition, and prevent or cure
disease.
Key Implications and Best Practices: Setcion 1
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.
- Intellectual property is a tool to foster innovation. Whether viewed as a legal concept, a social construct, a business asset, or an instrument to achieve humanitarian objectives, the value of intellectual property cannot be disputed.
- IP rights are a compromise and an imperfect solution, representing the search for balance between making all knowledge available within the public domain and granting ownership of valuable discoveries to the inventors. Reaching an appropriate balance requires continuous, sound IP management.
- The use of the existing IP system, coupled with sound patenting and licensing strategies, resolves the apparent paradox: the pursuit of the public interest through private rights.
- The emerging global systems of innovation in health and agriculture open up new prospects for innovation everywhere. This notion, that public interest can be served through private rights, has profound implications for the management of innovation, technology transfer, market competition, and economic development in every country, regardless of its economic status.
- Innovation is a complex process. It is stimulated by coordinated and structured policies and programs. The IP management system is an important factor, but it is only one of six factors that determine a country’s or institution’s ability to innovate.
- Your work is part of a larger innovation process that spans R&D across the public and private sectors, using regulatory systems, enabling the ability to produce new products to high standards of quality, allowing for the national distribution of new products through the public and private sectors, accessing foreign technologies, and managing intellectual property in a way that fosters partnerships.
- Research is the very foundation of innovation. Research leads to discovery; discovery fosters invention; inventions nourish innovation.
- Your sustained interest in your invention is important if it is to reach the marketplace, especially if it is to benefit those who most need it.
- It will be wise to consider the ethical implications of your research.
- You should always obtain prior informed consent when you access other people’s materials or samples irrespective where they originate.
Abstract
Building Product Innovation Capability in Health
by Richard T. Mahoney
Abstract:
This chapter presents a theoretical framework to explain the role of intellectual property (IP) in innovation and applies the framework to the growth of the pharmaceutical industry. Developing countries progress through stages of capability to reach the status of Innovative Developing Country (IDC). To reach the status of an IDC, countries need to give concerted attention to six components of product innovation: R&D in the public and private sectors, regulatory mechanisms for drugs and vaccines to achieve safety and efficacy, the ability to manufacture to high standards new health technology products, national distribution systems in both the public and private sectors, international distribution systems (including supply of drugs and vaccines through international organizations such as UNICEF, the operation of global funds, and trade among countries), and systems for managing IP.
An analysis of pharmaceutical innovation in Korea’s vaccine industry concludes that its success in developing its impressive capabilities was achieved by paying close attention to all six components of innovation. Yet unknown is the extent to which the Agreement on Trade-Related Aspects of Intellectual Property will stimulate or thwart progress in the other innovation components when IP is quickly moved to an advanced stage.
Abstract
Genomics, Ethics, and Intellectual Property
by Gary E. Marchant
Abstract:
Ethical concerns and controversies about patenting are playing an increasingly prominent role in the development and applications of the biosciences. Despite the growing importance of ethical issues, there is currently no consensus or clarity on the ethical principles that should guide patenting of human, animal, and plant genes and cells. The three major areas of contention are: (1) whether some or all patents on genes and cells are unethical per se, based on concerns such as commodification, dignity, and similar concepts; (2) how tissue samples are collected, particularly in reference to the principles of prior informed consent and benefit sharing; and (3) how patents are used to restrict access to medical and agricultural use of biotechnology innovations. Given the lack of any agreed guiding principles for navigating these issues, policy-makers, decision-makers, scientists, and users of biotechnology have no choice but to address these contested ethical concerns using a case-by-case approach.
Abstract
The Role of IP Management in Health and Agricultural Innovation
by Richard T. Mahoney, Anatole Krattiger
Abstract:
Recent national and international changes in intellectual property (IP) legislative frameworks are likely to have profound effects 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. Whereas IP rights are sometimes viewed as creating barriers to access to innovations in health and agriculture, we argue that it is not intellectual property, per se, that raises barriers, but rather how intellectual property is used and managed, particularly by public sector institutions. Above all, we argue that intellectual property is only one of six components of innovation. It is rarely the most important component.
The chapter reviews recent dramatic developments in institutional aspects of intellectual property, as well as global policy shifts and international studies that, among other outcomes, affected the environment for the creation of MIHR and PIPRA. 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. In addition, we argue that IP management should be seen as an important element in developing countries’ strategies to become more innovative in addressing diseases of poverty, the alleviation of poverty, and malnutrition. The public sector can employ new ways to achieve its goals within the evolving IP framework. These new ways can help it better mobilize the resources to take a product through the process of innovation. These new ways should include, a) creative licensing practices that ensure global access and affordability, b) improved institutional IP management capabilities, c) the formulation of comprehensive national IP policies, and d) the strengthening of IP court systems and patent offices.
These are what best practices in IP management are all about, and what this Handbook seeks to help bring about and promote.
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