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The U.S. Supreme Court ruled unanimously Thursday that scientists and biomedical companies cannot patent human genes such as the one carried by Angelina Jolie that dramatically increases her risk of developing breast and ovarian cancer.
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The case, in fact, involved a challenge to the patent held by Myriad Genetics on the test for the BRCA1 and BRCA2 genes, which Jolie underwent. Mutations in those genes increase the hereditary risk of developing both breast and ovarian cancer and, when Jolie discovered their presence in her DNA, she underwent a double mastectomy as a preventive measure.
Scientists and biomedical research companies have argued that isolating disease-linked genes from the human genome often requires years of painstaking research with costs running into the hundreds of millions of dollars. Patenting such findings for profit, they contend, is the only sure incentive for what often amounts to life-saving science. The American Civil Liberties Union, acting on behalf of a number of scientific and patients’ groups, disagreed, contending that patents are intended to protect “human-made inventions” and not pure “products of nature.”
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The court agreed. Writing for his undivided colleagues, Justice Clarence Thomas said, “Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material. … Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The justices, however, agreed with the position taken in the case by the Obama Administration that cloned or “artificial genes — called “complementary or cDNA” — can be protected by patent, since their creation involves synthesizing information from a natural genetic template and then using it produce cloned genes. “cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments,” Thomas’ opinion said.
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Dr. Beth Karlan, director of the Cedars-Sinai Women’s Cancer Program at the Samuel Oschin Comprehensive Cancer Institute, said the Supreme Court ruling will save “many thousands of lives” because more people will be able to afford the genetic testing necessary to determine if they are at risk for cancer. The cost of testing for BRCA 1 and BRCA 2 mutations alone was about $4,000 before Thursday’s ruling. Now it could drop to under $400 for a large panel of cancer causing genes, Karlan said.
“The price has been inflated due to exclusivity of the patent,” said Karlan, one of the country’s top ovarian cancer doctors, specializing in the study of the BRCA gene.
Karlan said that a number of genetic testing companies already have been identifying the deadly BRCA mutations as part of their multi-gene test panels. But because of the way the patent was worded, they were forbidden from telling patients that they had tested positive for the gene. That information could only come from patent holder Myriad.
Karlan said she is heartened that all nine justices agreed that human genes are not patentable. “It’s transformative,” she said. “By giving people better access to genetic testing and allowing scientists to do more research on their genes, we’ll be able to get the answers we need to find cancers earlier and to help people take preventative actions to avoid cancers that could threaten their lives.”
Andy Funk, co-founder and executive chairman of Pink Lotus Breast Center, where Jolie underwent her double mastectomy, called the ability to test for a BRCA gene mutation “critically important.”
“For patients with a possible BRCA gene mutation, the most significant aspect of this decision may be a drop in the price of the test, which has so far been dominated by Myriad Genetics via their gene patent,” Funk said. “A competitive environment could result in an affordable test that would allow BRCA gene testing to uninsured and underinsured women — a change that will save lives and that we undeniably support.”
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