When Wendy Chung first started working with the ACLU to bring a case against Myriad Genetics, challenging its patents on two genes linked to breast cancer, many legal scholars said that the case would be an exercise in futility.
“I considered this my Don Quixote experience in life. That I would be going up against a windmill and there would be no opportunity to knock down patents,” says Chung, who is director of clinical genetics at Columbia University Medical Center.
But Chung persevered because of her patients. “Genetic testing is an important part of what I do to help people, but we were having difficulties getting access,” she says.
The tests her patients needed either were too costly—in the case of BRCA1 and BRCA2 tests from Myriad—or were unavailable when labs holding the patents stopped offering the tests. Chung approached the NIH and Congress with her concerns and then finally the ACLU, which suggested bringing a case against Myriad as one example of how gene patents were harming patients and patient care.
The case worked its way to the Supreme Court, and on June 13 the court issued a unanimous
(9–0) decision that natural genes cannot be patented. (Although the court let stand patents on human-made genes, including versions of human genes that omit extraneous pieces of DNA naturally found in human genes, Chung says that will have little effect on the majority of diagnostic gene tests.)
“I think the most immediate implication for women who need a breast cancer test is going to be that other laboratories will start offering the test, and potentially they will offer a test that includes a panel of 10 to 20 other genes, so women will get more valuable information,” Chung says.
“But the biggest implication of the decision, in my opinion, is that we are not going to be impeded in giving full information to our patients about all of their genes. We can now sequence a patient’s entire genome, but we had to put blinders on when it came to 20 percent of their genes. That’s huge in the way we’re advancing in genetic and genomic medicine.”