The US Supreme Court ruled this morning that human genes cannot be patented. My research and clinical colleagues are overjoyed! The suit was brought forward by the Association for Molecular Pathology against Myriad Genetics. The defendant, Myriad Genetics, has held patents for the BRCA1 and BRCA2 genes since the mid 1990’s. Women with mutations in BRCA1 and BRCA2 are at high risk for developing breast and some other kinds of cancers. Men with mutations in BRCA2 are also at a high risk for breast cancer.
Myriad Genetics has been the only company that clinicians could refer patients for identification of BRCA1 and BRCA2 mutations. Myriad Genetics has not licensed other companies to do the testing. It costs around $3000 to get the test done and most insurance companies cover the cost for patients with family history of breast and/or ovarian cancer. If you can shell out the $3000, Myriad Genetics conveniently offers direct-to-consumer testing for BRCA1 and BRCA2—allowing you to bypass your physician altogether!
The monopoly held by Myriad Genetics will now come to an end. It was wrong to begin with!
Why should a company be able to patent genetic information that exists in all of us? Patenting the technology or method used for discovery of the genetic material or gene sequence is legitimate but not the sequence itself. It seems absurd to me that a company can file for a patent for a naturally occurring phenomenon. Our bodies have been making use of that genetic information for a lot longer than Myriad Genetics has been in existence—sans patent.
The Supreme Court ruling is a win for patients (consumers). With the patent ruled unconstitutional, other companies can develop methods or use existing, publicly available, technologies, to sequence BRCA1 and BRCA2, in addition to other cancer susceptibility genes. With additional competition, we can hope for a test that costs less than $3000. This is a reasonable expectation since scientists are currently racing to sequence the entire human genome (>20,000 genes and other non-genic regions) for $1000. We can also hope that these companies will encourage public sharing of information about different mutations that may us better understand a class of mutations called variants of unknown significance, discussed elsewhere. Myriad Genetics stopped sharing this kind of information a few years ago because it “doesn’t make a lot of business sense,” according to CEO Peter Meldrum1.
What about business and the bottom line? Myriad Genetics will continue to profit from BRCA1 and BRCA2 testing as they hold the experience, expertise and a large database. Perhaps the profit margin may go down as competitors enter the market. There is now space in the market for others to get a piece of the commercial genetic testing pie.
Overall, this is a huge victory–for patients, clinicians and scientists.