Should corporations be able to patent human genes — parts of the human body that reside in all of us? The Supreme Court is considering that question today, and while it sounds very much hypothetical, it has very real and serious implications. Consider the case of 10-year-old Abigail, who had long QT syndrome, a serious heart disease. There is a genetic test that can detect the disease, but the long QT genes were patented, and for two years the only lab that could legally perform the test was not testing. During those two years, Abigail died.
The idea that corporations can patent genes is disturbing and in some cases deadly — but it is the law, at least for now. Today’s case could produce a landmark ruling that either allows corporations to go further to lock up genes with exclusive patents, or unshackles human genes, allowing doctors and researcher to work more freely in combating deadly diseases.
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People’s genes can say a great deal about their health. There are genes that reveal an increased likelihood of getting cancer, heart disease or Alzheimer’s. Today’s case focuses on two genes that have genetic mutations that can indicate a higher risk of breast and ovarian cancer. When doctors know that a woman carries these genes — BRCA1 and BRCA2 — they can provide appropriate and often life-saving treatments.
Unfortunately for carriers of the BRCA1 and BRCA2 gene, a Salt Lake City–based company called Myriad Genetics asserts that it has a patent over “isolated” forms of these two genes. That means that Myriad has exclusive control over testing for BRCA1 and BRCA2. That is a too much power to put in one company — and the stakes are high. Medical experts have told the court that Myriad’s patents have led to people being misdiagnosed. One study found that models used by Myriad significantly underestimate the presence of BRCA1 and BRCA2 mutations among Asian-American women.
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Gene patents can also discourage scientists from conducing research that could lead to cures and better therapies. A survey of more than 130 genetic laboratories found that 53% of the respondents chose not to develop or perform genetic tests for clinical or research purposes because there was a patent. In a friend-of-the-court brief, the AARP argues that gene patents may be deterring research for Alzheimer’s, for which there are currently no curative measures available.
On the law, this should not be a hard case. The Supreme Court has long held that patents can protect products of human ingenuity — but not laws and phenomena of nature. Human genes are clearly parts of nature — not human creations. Myriad argues that it is not patenting nature when it patents genes because it is protecting the process of isolating those genes from the body. But as the American Medical Association argues in a brief, that is like saying that the first surgeon who removed a kidney should be able to get a patent on all “isolated” kidneys.
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The Supreme Court has also emphasized that the patent system must effectively guard the rights and welfare of the community — that is, patents must benefit, not harm the public. It is hard to imagine a case in which patents do more harm than this one — blocking important medical research, and interfering with sick people’s ability to get the tests and treatment they need to save their lives.
An array of biotechnology companies have lined up on Myriad’s side, for obvious reasons — the amount of money that can be made by owning patents to important genes is astronomical. But advocates for patients — particularly women, who have a special interest in the BRCA1 and BRCA2 genes — are just as emphatic that the Supreme Court must strike down the patents. They insist that if Myriad wins, people with a wide variety of diseases will suffer and die needlessly.
The American Medical Association has it right: it told the Supreme Court that physicians and researchers’ access to genetic sequences “is a matter of national importance and urgency.” Patents have a place in medical science — for new inventions that advance the state of knowledge. But the Justices should use today’s case to make a clear statement that genes and other human body parts belong to people, not corporations.