Based on its study, SACGHS found that patents on genetic discoveries do not appear to be necessary for either basic genetic research or the development of available genetic tests. The Committee also found that patents have been used to narrow or clear the market of existing tests, thereby limiting, rather than promoting availability of testing. SACGHS found that patients have been unable to obtain testing when a patent-protected sole provider does not accept particular payers, particularly state Medicaid insurance. SACGHS also found that when there is a patent enforcing sole provider, patients cannot obtain independent second-opinion testing, and sample sharing as a means of ensuring the quality of testing is not possible. The substantial number of existing patents on genes and methods of diagnosis also pose a threat to the development of multiplex testing, parallel sequencing, and whole-genome sequencing, the areas of genetic testing with the greatest potential future benefits.
Department of Health and Human Services