NEW YORK, June 13, 2013 — The Supreme Court of the United States ruled unanimously (9 - 0), today that drug and research companies may not patent human genes simply because they have discovered the precise location and sequence of those genes.
The central question for the justices came from the case Association for Molecular Pathology v. Myriad Genetics, No. 12-398, specifically concerning the BRCA1 and BRCA2 genes, which relate to breast and ovarian cancer. Statistics say about 1 in 8 U.S. women (just under 12%) will develop invasive breast cancer over the course of her lifetime.
Ovarian cancer accounts for approximately three percent of cancers in women. While the 10th most common cancer among women, ovarian cancer is the fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers.
Justice Clarence Thomas, writing for the court, said that merely isolating those specific genes — called BRCA1 and BRCA2 — was not worthy of a patent.
“Myriad found the location of the BRCA1 and BRCA2 genes, but that discovery, by itself, does not render the BRCA genes … patent eligible,” Thomas wrote.
Most following the case see the ruling as simple common sense, “We hold that a naturally occurring DNA segment is a product of nature and not patent-eligible merely because it has been isolated,” said Justice Clarence Thomas for the court. The gene is a product of nature, Myriad did not create anything.
“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,” Thomas said.
It seems hard to argue in favor of patenting something that occurs in nature, and that no one had any hand in creating or modifying in any way. “The location and order of the nucleotides existed in nature before Myriad found them,” Thomas wrote. “Groundbreaking, innovative, or even brilliant discovery,” doesn’t satisfy the requirement that inventors invent something, he said.
The debate lies more in whether the ruling hurts or helps research in an important area. Some argue that the ruling will impact negatively the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.
Others hold the opposite. The American Civil Liberties Union praised the high court’s ruling as a victory. “Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park of the ACLU, which represented the groups that brought the challenge. “Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued.”
The ruling was not a plain slap in the face for companies like Myriad, which is responsible for important advances in medical research. The court, as Thomas wrote may patent the methods of isolating genes, and they may patent complementary DNA, or cDNA, which is created by inventors, rather than simply occurring in nature.
While obviously an important matter that affects us all, especially as it affects so many of the women we love, our sisters, moms, wives, daughters and friends, the issue also is currently high in the public attention due to actress Angelina Jolie’s letter to the editor to the New York Times, in which she revealed that she had a double mastectomy because the test showed she carried the defective gene.
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