Patent protection for breast-cancer genes may be ending

As reported in the New York Times and elsewhere earlier this week, a federal district court judge has invalidated the patents held by test manufacturer Myriad Genetics on the BRCA1 and BRCA2 genes.

Mutations in these genes play a role in a small proportion of breast cancer cases -- that is, most breast cancer does not appear to have a strong genetic contribution, and genetic testing really makes sense only for women with a strong family history, as explained here -- but women who have one or more mutations have a substantially higher risk of developing breast and/or ovarian cancer. Men with these mutations stand an increased chance of getting prostate cancer and (in rare cases) breast cancer.

Myriad's most comprehensive test, which looks for mutations in both the BRCA1 and BRCA2 genes, costs more than $3,000. Critics charge that Myriad's monopoly and refusal to license the test has had negative effects on patient care, in that some women who may benefit from testing cannot afford it, and confirmatory testing is not available from another source.

The suit was brought by a group of patients, advocacy groups, scientific organizations, and the ACLU; it is almost certain to be appealed. The ruling contradicts more than 20 years' worth of cases that have allowed gene patenting. It will be interesting to see where this goes. GenomeWeb has a nice summary of the blogosphere's reaction here, and Genetic Future (as usual) has some smart commentary too.