In these days of political polarization, how often does the United States Supreme Court make a unanimous decision? When the case has to do with human genes and their patentability!
The case concerned patents held by Utah firm Myriad Genetics on the BRCA1 and 2 genes. Mutations in those genes confer an increased risk of breast and ovarian cancer. The patents in dispute claimed the genes themselves rather than just the technology for reading them.
Cecelia Bellcross, director of Emory’s genetics counseling program and an expert on breast cancer genetics counseling, reports that “in general, the clinical genetics community is jumping up and down, as are a lot of genetics lab directors and definitely patient advocacy groups.â€
Myriad’s BRCA tests cost more than $3,000. Several competing firms announced that they would offer tests for the BRCA1 and 2 mutations at significantly lower prices.
Emory human genetics chair Steve Warren was Ray Ban Baratas one of the petitioners in the case, along with David Ledbetter, who was at Emory until 2010.
“Essentially this decision allows diagnostic laboratories, like ours at Emory, to test any gene associated with a disease without fear of legal repercussions or paying huge licensing fees,†Warren says.
With the advent of microarrays and whole exome and even whole genome sequencing, genetic testing technology has moved far beyond testing one gene at a time.
“With whole genome sequencing, now we can clinically interpret the sequence while prior to this there would be genes, like BRCA1 and 2, that would be off limits,†Warren says.
The ruling draws a line between patenting of genomic DNA or natural DNA sequences, and complementary DNA, a copy of spliced messenger RNA that does not exist inside the cell (usually*) but can be produced by scientists in the laboratory. Patents on complementary DNA (cDNA), which can be a tool for the production of new engineered proteins, are not excluded, the Supreme Court ruling says.
“The support of cDNA is fine as cDNAs have little involvement in genetic testing and are important to biotech companies. So it is a huge victory,†Warren says.
Myriad still has cDNA patents related to BRCA so there is uncertainty about how those would play out, and whether the decision might discourage investment by private industry in genetic testing.
Emory Genetics Laboratory developed and validated a BRCA test a couple of years ago in anticipation of the decision, executive director Madhuri Hegde says. EGL will launch it soon along with expanded testing for other cancer genes. EGL offers testing for almost all inherited cancers – a strong position to be in now, she notes.
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