Gene patents and genomic databases: The long-term consequences of exclusive rights to conduct genetic tests

Policy debates over gene patents, as well as ongoing litigation, have focused on the appropriateness of ownership rights for genes, the effects of patents on research, and the protection of innovators' interests. Largely ignored has been another issue of perhaps greater clinical and economic significance: patent holders are able to accumulate large and valuable databases of test results over which they maintain exclusive control. This information is an increasingly crucial resource for research and clinical care. For example, patents for the BRCA1 and BRCA2 genes, which indicate risks for breast and ovarian cancer, are held by Myriad Genetics, which conducts all clinical testing concerning them. Its database includes findings not only on mutations known to indicate heightened cancer risk but also on thousands of other genetic variations whose clinical significance is not well characterized. Linking data on such “variants of uncertain significance” with information on family histories and clinical outcomes, which Myriad also collects, is the only effective way to determine these variants' clinical meaning. On one hand, the concentrating effect of the patents allowed this information to be collected. On the other hand, the company limits access by outside researchers and clinicians, allowing it to control and possibly stifle research on the BRCA genes long after its patents have expired and potentially to maintain a dominant market position indefinitely. If the Supreme Court ultimately upholds Myriad's patents as a result of ongoing litigation, legal reforms are needed to limit these possible adverse long-term effects.