Protesters hold banners demanding a ban on human genes patents during a… (Mladen Antonov / AFP/Getty…)
It's hard to imagine Supreme Court justices paying much attention to the travails of Hollywood's rich and famous. Still, there's an interesting connection between Angelina Jolie's disclosure Tuesday that she underwent a double mastectomy and a case the court is deliberating, the Assn. for Molecular Pathology vs. Myriad Genetics.
At issue is whether a human gene sequence can be patented. That's the broad question. The two specific sequences patented by Myriad -- BRCA1 and BRCA2 -- are genes that suppress tumors. A small percentage of women have defective copies of those genes, and they are extremely likely to develop a virulent form of breast cancer. They also face a higher-than-average risk of ovarian cancer.
Jolie, whose mother died at age 56 after a protracted battle with cancer, recently learned that she has a mutated BRCA1 gene. Her doctor told her that she had an 87% chance of contracting breast cancer and a 50% chance of developing ovarian cancer. By having a double mastectomy, she wrote in the New York Times, she dramatically reduced her breast cancer risk.
Myriad's patents give it an unusual degree of control over researching and testing for BRCA defects. Only Myriad can legally isolate the BRCA1 and 2 sequences. In the United States, that means only Myriad's lab can conduct a full sequencing test to check a patient for the innumerable possible mutations of those genes. Isolating the genes is also a prerequisite to doing research into the specific effects of those variations, said Sandra Park, an ACLU staff attorney who's been challenging the patents.
Myriad argues that it freely permits research on the genes. The company also has licensed other laboratories to check for some specific mutations of BRCA1 and 2. Those labs could provide a second opinion to confirm or reject a mutation found in a test by Myriad. The problem, Park said, is that a woman who doesn't know which mutation to look for has no choice but to go to Myriad for her test.
The monopoly provided by Myriad's patents allows the company to control the price of the test and determine what sort of research will be conducted. Opponents complain the price is so high that some lower-income women can't afford it. They also object to the idea of any company acting as a gatekeeper to medical research. The trove of data Myriad collects in its tests could be extremely valuable to researchers, but according to Park, the company has stopped contributing its results to an international database on the BRCA genes.
The justices don't have a problem with patents over plants and seeds, as evidenced by their unanimous ruling Monday in favor of Monsanto in a case involving genetically modified soybeans. The central question in the Myriad case, though, is whether a company actually invents anything when it isolates a genetic sequence. Backed by the biotech industry, Myriad argues that the isolated sequence is a patentable invention because it doesn't exist in that exact form within the body. Its opponents counter that Myriad merely discovered something that nature formed, and such things aren't patentable.
During last month's oral argument, the justices seemed split. Some wondered about the implications of allowing patents for items extracted from nature. Would that logic apply to a plant found in the Amazon jungle? Or to an entire chromosome extracted from a cell? Others feared that companies wouldn't be willing to make the investment needed to isolate sequences if they couldn't patent the results.
The court's decision could have a profound influence over what companies decide to invest in and develop businesses around. Myriad argues that barring patents over sequences will lead to less investment in the personalized diagnostic techniques that underlie the next generation of treatments. The ACLU contends that plenty of incentives exist for companies to sequence genes and develop diagnostic tests; the big investments in research and development that need patent protection are the ones needed to develop effective treatments.
The court's ruling is expected in June.
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