International Assessments of Patenting in Genetics

Evolving intellectual property (IP) policies of governments and organizations are impacting biotechnology sectors and access to genetic materials for development of pharmaceuticals. The National Institutes of Health, through the Human Genome Project among others, specifically recognizes the need for policy options in the area of intellectual property to facilitate the widespread use of genetic and genomic information in both research and clinical settings. Unfortunately, the empirical evidence on the impact of IP on research and development in genetics and genome-related life sciences is thin and under-analyzed. This project will comprehensively quantify the changing structure and innovation implications of genetics, genomics and biosciences IP patterns and policies from an international perspective. Complementing these largely empirical efforts, economic modeling components- closely conceived and performed with legal and biosciences expertise-will draw from and feed directly into various international initiatives (e.g., at WIPO) and programs (e.g., at Gates Foundation) addressing neglected health and diseases problems, as well as inform U.S. policy and decision makers. The proposed research addresses a range of critical and interrelated innovation incentive issues including: links between IP ownership and use, implications for generating and accessing key technologies, and types of licenses and institutional arrangements effective at disseminating different types of technologies originating in the public and non-profit sectors or the private sector. Through a coordinated program of institutional, economic, and legal research, this project will: a) undertake an in-depth quantitative assessment of the changing international patent landscape in the genetics and genomics area of the life sciences; b) investigate and map the forms and degrees of IP protection available under policies in the United States and a sample of developed and developing countries; c) investigate alternative institutional designs for sharing and accessing IP internationally; d) initiate a variety of communications activities designed to inform and influence IP policy and practice in both national and international arenas. The project outcomes are also expected to influence the development of specific institutional arrangements to facilitate the creation and exchange of genetics and genomics technologies internationally, and to establish effective mechanisms to promote innovation addressing neglected health needs and other priorities.R387

PUBLIC HEALTH RELEVANCE: This project will comprehensively quantify the changing structure and innovation implications of genetics, genomics and biosciences IP patterns and policies from an international perspective. Complementing these largely empirical efforts, economic modeling components-closely conceived and performed with legal and biosciences expertise-will analyze a range of critical and interrelated innovation incentive issue: including links between IP ownership and use, implications for generating and accessing key technologies, and types of licenses and institutional arrangements effective at disseminating different types of technologies originating in the public and non-profit sectors or the private sector.