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In March 2010, Judge Robert Sweet of the Southern District of New York issued a ruling against Myriad Genetics, holder of exclusive patents on the breast cancer genes BRCAl and BRCA2, indicating that genes should not be eligible for patent protection. In October, the Justice Department surprised policy watchers by filing an amicus brief in support of the ruling. James Evans (Figure 1), who chaired a task force on gene patents and licensing practices for the Department of Health and Human Services (HHS), recently spoke to the JCI about gene patents and the likely impact of this ruling.
JCI: About 20% of human genes are currently under patent protection. How does that affect researchers who want to work on those genes and gene products?
Evans: From a clinical standpoint, it is very restrictive. The genes under patent and exclusive license, like BRCA1/2, can only be analyzed by a single laboratory. For basic research, in practice, most holders of gene patents have not vigorously enforced their claim, even though in principle they could certainly keep anyone from doing research on a gene that they own a patent on. It's often been cited by proponents of gene patents, that there has been little patent-related restriction of basic research. But the reason for that is that patent holders have often chosen not to enforce their rights, and chat researchers have generally ignored patents, which is hardly a ringing endorsement of the system.
JCI: How did this most recent ruling affect those who currently hold gene patents?
Evans: In tangible, practical terms, the ruling by Judge Sweet doesn't do anything, because...