Specifically, the court ruled:
“It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA.”The Court acknowledged the work done by Myriad in locating the BRCA genetic sequence among the tens of thousands of nucleotides on each chromosome but held:
“In this case … 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.”So what does this mean?
- It paves the way for other companies to test for mutations on these genes and in fact companies have already stepped forward to offer BRCA testing.
- Patients will now have the opportunity for patients to get a second opinion to confirm their genetic test results prior to making life altering preventive surgery decisions.
- More women (and men) will have access to potentially life-saving genetic information because competition should lower the cost of these genetic tests
- No single company will be able to prevent others from conducting testing and research on the BRCA genes.
What does this decision mean for personalized medicine more broadly? This decision is a watershed moment with implications that reach far beyond the BRCA genes because approximately 25 percent of the humane genome has been patented. Several thousand companies currently own different slices of DNA and all of those patents have been invalidated by the Court’s decision.
The personalized medicine revolution is no longer being held hostage by the patent system.
Should you have questions about genetic testing, consult your genetic counselor and FORCE.
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