A group of doctors, researchers, and clinicians are suing a 15-year patent monopoly given to Myriad on a testing procedure called the BART test (BRAC Analysis Rearrangement Test), which the company provides at a $700 fee that is often not covered by insurance.
The patent was given based on the FDA's understanding that two other common (and patent-free) tests, the BRCA1 and BRCA2, are "comprehensive" and thus the BART test is not a monopoly that would significantly impact lifesaving benefits were it public.
The suit claims that neither the BRCA1 or 2 tests are comprehensive and that the BART test fills in their gaps, but without it, many patients are left wrongly diagnosed or not diagnosed at all.
At the heart of the dispute is whether or not genetic material can be patented, since the BART test relies heavily on a specific gene sequence, which the ACLU and other organizations claim is natural (made by nature) and thus not patent-able.
The suit will go before the U.S. Supreme Court this year.
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