Roundtable Summary on Genetic Patenting

National Human Genome Research Institute

National Institutes of Health
U.S. Department of Health and Human Services

Roundtable Summary

NHGRI Roundtable on Genetic Patenting
National Human Genome Research Institute (NHGRI)

Marriott Wardman Park
Washington, DC

December 4, 2002

The National Human Genome Research Institute (NHGRI) has held an almost two year long planning effort to help guide the institute into the new era of genome research that will follow the completion of the Human Genome Project (HGP) in the spring of 2003. As part of this process, the NHGRI has sponsored a series of workshops and roundtables focused on specific scientific, health and social issues topics. On December 4, 2002, the NHGRI held a roundtable to discuss genetic patenting. The purpose of the roundtable was to explore the ramifications, now and in the future of the patenting and licensing of genes, single nucleotide polymorphisms (SNPs), haplotypes and other types of genetic and genomic data (including compilations of such data in the form of databases) for research and health care. Attendees included a group of experts in patenting and licensing, along with stakeholders from industry, consumer organizations and research institutions.

Alan Guttmacher, the NHGRI deputy director, opened the roundtable by welcoming the participants and describing the NHGRI planning process and some of the concepts that have been proposed for the future, including the possibility of sequencing a genome for $1,000. He suggested that the ability to sequence a genome for $1,000 would change the practice of medicine. However, a fundamental question is how to provide access to genetic information and inventions without inhibiting the commercial development of new products and services by the biotechnology and pharmaceutical industries.

As background for the roundtable dialogue, several individuals gave brief presentations. Lawrence Sung discussed the future of the "research exemption" and the implications of the recent Madey v. Duke decision. In Madey, the Federal Circuit Court of Appeals essentially ruled that university scientists must obtain permission before using patented technologies. Robert Cook-Deegan presented information on licensing and its impact on health care delivery. He presented data from a project funded by the NHGRI and the DOE regarding the creation of a database of DNA patents and a new survey on licensing practices at U.S. and Canadian academic and non-profit institutions. John Iwanicki discussed the pros and cons of federal patenting legislation, including the concepts that the patent system promotes investment and rewards routine discovery, but sometimes discourages innovation.

Following the opening presentations, all those gathered for the roundtable considered the three primary discussion topics: (1) Is there a problem with genetic patenting and licensing today? If so, what can be done to fix it? (2) What are the implications for the future? and, (3) What is the role of the NHGRI?

The key points were as follows:

Potential Action Items

Regarding genetic patenting, NHGRI and/or NIH should consider the following:

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Last Reviewed: April 19, 2012