Gene patenting and licensing: the role of academic researchers and advocacy groups.

The subject of human gene patenting has received a great deal of media attention, and many individuals and professional societies (including the American College of Medical Genetics) have voiced strong opinions against the patenting of human genes. A particular concern of the medical genetics community is the impact of gene patenting on accessibility to high-quality genetic testing. There has been significantly less media attention and public discussion of licensing practices (e.g., exclusive versus nonexclusive) and their role in promoting or limiting access to genetic testing. Current US government policy strongly encourages universities to commercialize inventions funded by federal grants (Bayh-Dole Act, 1980). Best Practice models for technology licensing have recently been developed by the National Institutes of Health and by the Association of University Technology Managers, and strongly encourage nonexclusive licensing strategies except in cases where this model will not lead to successful commercialization. In the case of genetic testing, nonexclusive licensing strategies (e.g., CF gene) have the significant advantages of encouraging multiple laboratories to make the test readily available, encouraging test improvement, and creating cost-competition. Individual investigators involved in gene discovery, and patient advocacy groups collaborating with academic investigators, have the opportunity to influence the accessibility of diagnostic testing by strongly encouraging their institutions to follow the National Institutes of Health and Association of University Technology Managers Best Practice models of nonexclusive licensing for diagnostic rights to human gene patents.