Actress Angelina Jolie isn’t directly a part of a big Supreme Court decision arriving in the next two weeks, but her genetics will play a part in publicity about a patent case with wide-ranging implications.
Jolie made global headlines in April when she announced that she underwent a double mastectomy after medical tests revealed she was at a high risk of developing breast and ovarian cancer.
It’s the technology behind the cancer-screening tests that is at the center of the legal fight in Association for Molecular Pathology v. Myriad Genetics, Inc.
Myriad Genetics holds a patent for research that involves two human genes called BRCA1 and BRCA2. Myriad’s tests reveal mutations of the genes that are linked to hereditary breast and ovarian cancer. A blood sample is required for the tests.
Myriad says people with BRCA1 or BRCA2 mutated genes have risks of up to 87 percent for developing breast cancer and up to 44 percent for developing ovarian cancer by age 70.
Jolie’s announcement and her op-ed story in The New York Times put the Supreme Court case in the public spotlight. But the fight over the genetic test goes back to 2009, and it has been closely watched by the scientific, medical, and research communities.
Myriad Genetics applied for and received patents on the two genes in 1997 and 1998, and it owns the rights to the cancer-screening test involving the genes. It spent a reported $500 million on the project.
The genes are called “isolated genes” because they are actually extracted, or isolated, from a strand and fragmented outside of the body, which makes it easier for researchers to determine if they are markers for cancer susceptibility.
A gene patent isn’t that unusual. There are an estimated 3,000 to 5,000 gene patents on record at the U.S. Patent and Trade office, says the Hastings Center, a nonpartisan bioethics research institution. HowStuffWorks also has helpful, detailed explanation about the history of gene patents and the related legal and ethical issues.
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In a statement, Myriad said that, “no organization, including Myriad, has ever sought to patent genes in anyone’s body. Rather, Myriad created synthetic molecules of DNA in the laboratory that are used to test patients for increased risk of breast cancer and ovarian cancer. Those synthetic molecules are different from what is found in nature or the human body.”
The challengers in the case believe that human genes aren’t patentable because they are products of nature, and that Myriad doesn’t have the patent rights to BRCA1 or BRCA2 mutations that haven’t yet been discovered.
The justices heard the case in April. The decision will be announced on June 10, June 17, or June 24.