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MIHR
PIPRA
Fiocruz, Brazil
bioDevelopments- Institute
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CLIFT, Charles
Charles Clift has had a great deal of experience in the U.K. Department for International Development (DFID), where he works principally as an economist on all aspects of DFID’s work. He began his career as an agricultural economist, advising DFID on its agricultural research priorities. He has lived and worked in Africa, the Caribbean, and India. He has also been responsible for the management of DFID’s economic and social research, and the coordination of all of DFID’s research programmes, including those concerned with health and agriculture. From 2001 to 2002, he acted as Head of the Secretariat of the U.K. Commission on Intellectual Property Rights (www.iprcommission.org). From 2004 to 2006, he was employed in a similar capacity by the WHO Commission on Intellectual Property Rights, Innovation and Public Health (www.who.int/intellectualproperty).
 Abstract
Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals
Abstract:
The chapter discusses the meanings of data protection and data exclusivity in the context of the provisions of the Trade-Related Aspects of Intellectual Property Rights agreement. In addition, it outlines the relationship between data exclusivity and patent protection and briefly reviews the possible costs and benefits of introducing data exclusivity laws. Finally, the chapter explains that countries need to consider the costs and benefits when negotiating bilateral trade agreements that might require the introduction of these laws.
Abstract
Patenting and Licensing Research Tools
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.
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