Credit: Mark Fischer on Flickr, under Creative Commons (CC BY-SA 2.0).
(WOMENSENEWS)--On April 15, the Supreme Court will hear oral arguments in a gene-patenting suit that is important for anyone concerned about breast cancer treatment, medical research, health screening and medical costs.
The case also holds huge implications for ovarian and prostate cancers, and it looms over the treatment of pancreatic and skin cancers as well.
"The central issue of this case," writes lawyer John Hendricks in an amicus brief on the case, "is whether human genetic material, or a segment of the human genome, upon isolation and/or extraction from the body, constitutes patent-eligible subject matter . . . To be clear, the patents now at issue do not claim a means of isolating or extracting the gene, they claim the gene itself as invention."
The Association of Molecular Pathology v. Myriad Genetics (also known as the ACLU/Myriad "gene patent" case) began in 2009 and--seeing various appeals and reversals along the way--has made its way to the highest court of the United States.
This patent has been ruled against and upheld in court various times, but the most recent ruling, issued in 2012 by the U.S. Federal Circuit Court of Appeals in Washington, D.C., upheld it.
The patent concerns genes we all possess--men and women, girls and boys--that have come to be called BRCA (an abbreviation for breast cancer). Myriad Genetics' patent covers all forms of the genes once they are isolated, or taken from the body.
The Federal Circuit Court decided that isolated DNA molecules have "markedly different" characteristics than native DNA and therefore do not count as "products of nature," which cannot be patented.
Certain mutations on these genes, particularly the BRCA1 and BRCA2 genes, greatly increase the lifetime risk of breast cancer for both men and women. They also significantly increase ovarian and prostate cancer risk. Less drastically but still very notably, these mutations can increase the risk of pancreatic and skin cancer for both sexes.
A test can determine whether someone is a carrier of one or more mutations to the BRCA genes. Myriad Genetics, based in Salt Lake City, developed this test and owns the exclusive rights to perform it. But Myriad has also claimed a patent on BRCA genes themselves when they are isolated from a person's body.
The patent, Hendricks said, gives the owner the right to restrict the use of the material for other research without a license from Myriad. "And they don't have to grant the rights, for any price," he added. "The decision is up to them. This restricts the amount of research that can be done on these genes."
If Myriad holds on to the patent--which can essentially monopolize involvement with BRCA genes--this outcome will have both immediate and long-term health care consequences.
For example, some patients, such as Andrea Marks, are waiting for information about their BRCA mutations that does not exist yet. Her mother died of breast cancer, and Marks herself has had a stage 4 breast-cancer recurrence. Marks, who asked to use a pseudonym to protect her privacy, was told at the time of her initial stage 2 breast cancer diagnosis that she had a "BRCA1 mutation of unknown significance." But her care and treatment are limited by incomplete information on her specific mutation. And other companies cannot freely do research on it unless the patent is lifted.
"It's horrible that they can be paid thousands of dollars to provide an 'unknown significance' test result," Marks said. "They tell the patient to keep checking back to see if there has been any more information found. I would think that getting this much money, and since they have every single tested patient's BRCA data, they would be further along by now."
At the same time, "inaccuracies in testing can occur," said Hendricks from his office in Austin, Texas, as he geared up to attend the hearing in Washington, D.C. "Because of the patent, other parties cannot offer a second opinion."
Karuna Jaggar, executive director of the San Francisco–based advocacy group Breast Cancer Action, which is a plaintiff in the case, said expense is definitely an issue. The BRCA test has several "levels," and the most extensive can cost up to $3,000, which may or may not be covered by insurance. The test, Jaggar added, "could be done more cheaply and more comprehensively by other labs"--but that won't happen with this patent in place.
If a woman tests negative for BRCA1 and BRCA2 mutations but has a strong family history of breast cancer, an extended test, called BART, can be performed. However, personal finances can unfortunately come into play again with this test, also developed by Myriad.
"I was tested two times," said Susan Slate, a breast cancer survivor who also asked to use a pseudonym to protect her privacy. "I tested negative but was retested using fuller sequencing after my diagnosis. Still negative. When BART came out in 2007, I was told I'd have to pay Myriad $700 more for it. I declined."
Slate is now unemployed and uninsured and said she worries that her daughter does not have all the information she needs to make her own health care decisions. "My mother passed away from breast cancer when I was in treatment, and three of her five sisters had breast cancer. I dearly hope the Supreme Court overturns this patent--doing so could, among other things, make complete testing more affordable," she said.
If the patent stands, why wouldn't Myriad simply grant research access to labs that can pay?
"Patents do run out eventually," said Jaggar, who will be attending the Supreme Court hearing. "But hoarding biological data on BRCA gives Myriad the competitive data advantage for the next innovation."
"There are other patents on human genes," Jaggar continues. "But what you see here is the worst-case scenario of gene patents--an egregious example of a company putting profit before public health. Other patent holders on genes are open in sharing information. Myriad is uniquely litigious and is blocking progress and research."
Myriad, in a 2011 press statement, said it "plans to continue its strong commitment to promoting women's health in the areas of hereditary breast and ovarian cancer, advancing and fostering research on the BRCA genes and providing excellent patient access to its test."
Hendricks, meanwhile, questions the overall principle of patenting genetic material. "Why wouldn't we be able to patent isolated chemicals? A kidney? An electron? We can't patent them now because it is understood that everyone needs access to them to further human health. How, really, is the BRCA gene different?"
Pamela Grossman is a writer and patient advocate living in Brooklyn, N.Y.
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