In June, the US Supreme Court unanimously decided that our genes are not patentable. The decision invalidates patents on genomic DNA – that is, one company can’t own your genes anymore.
Why should we, as physicians and patients, care about this landmark decision?
As a new physician, 22 years ago, I did clinical testing to identify changes in the genes of patients to find out what caused their diseases. The tests for several different diseases were not only useful for diagnosing the disease of the patient, but also for testing their family members who also may be at risk for the disease.
While at the Hospital of the University of Pennsylvania, I began receiving letters from companies and other academic institutions telling me I had to stop doing this clinical testing because they had a patent on the disease gene I was testing. I was very frustrated for my patients, and began to speak out about the impact of gene patents on medical care. I spoke at grand rounds for academic medical centers, at patent lawyer meetings, at national conferences, as well as working on a national report on the medical impact of gene patents on patient access to testing for the Secretary of Health and Human Services.
Momentum for stopping the patenting of genes needed for medical care grew. The American Civil Liberties Union took up the cause and represented a group of plaintiffs representing medical societies, physicians, patient organizations, and patients against Myriad Genetics Inc. to try to invalidate their patents on the breast cancer genes, BRCA1 and BRCA2.
Until June, the only place in the US for a woman to have BRCA testing done was through Myriad Genetics Inc.
Public testimony before the Secretary’s Advisory Committee on Genetics, Health and Society had clearly demonstrated that women could not get testing when needed because of insurance coverage issues and the high cost of the testing through Myriad.
With the US Supreme Court decision, genes as found in nature, for example in a person’s body, are not able to be patented. It is estimated that almost one quarter of the human genes are patented. Although this decision is specific for the BRCA1 and BRCA2 genes, this sets a precedent in the courts that makes the other gene patents unable to be enforced to stop medical testing.
This is truly a victory for patients and medical care, and firmly opens the door to the use of individual patient’s genomic information with the goal of improving their healthcare, and moving toward disease prevention in the future.
Debra G.B. Leonard, MD, PhD is Chair of Pathology and Laboratory Medicine at the University of Vermont Medical Center, and Chair and Professor of Pathology at the University of Vermont College of Medicine. She also chairs the Personalized Health Care Committee of the College of American Pathologists.