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Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests 

EXECUTIVE SUMMARY
 
A.  Introduction
 
The development of and equitable access to clinically useful, high-quality genetic tests has been a central concern of the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) since its first meeting in June 2003. Given this focus of SACGHS, in 2004 the Committee noted conflicting viewpoints concerning whether gene patents and licensing practices benefit or harm genetic research and genetic test development, patient access to these tests, and genetic test quality. At that time, the Committee decided to undertake a study of these issues to determine whether the weight of the evidence pointed to net benefits or net harms for patients. 
 
In this report, “patent claims to genes” and similar expressions, such as “patents on genes,” refer to claims to isolated nucleic acid molecules whose sequences correspond to human genes, mutations, fragments of genes or mutations, or intergenic DNA. The expression also refers to claims to processes for the detection of specific nucleic acid sequences. “Association patent claims” and equivalent phrases refer to claims to processes of simply associating a genotype with a phenotype. 
 

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