Supreme Court Decision – Genes Can’t Be Patented

In a victory for consumers, patients, researchers and women, the Supreme Court today returned a decision that human genes cannot be patented.

Their decision states that DNA ”is a product of nature and not patent eligible merely because it has been isolated.”

This case was a result of a suit against Myriad Genetics, a company that was granted patents for isolating two human genes, known as BRCA1 and BRCA2, both of which are well known breast cancer genes, recently brought to light by Angelina Jolie’s decision to have preventative mastectomys after both the gene and related breast cancer were found to be prevalent in her family.  Shortly after that decision and surgery, Jolie’s aunt died of breast cancer.

While companies cannot patent the genes themselves, they can develop treatments and hopefully, cures, and those can be patented.  Synthetic genes created are also eligible for patents.  Myriad wasn’t the only company to do this.  The government has issued patents to over 4000 genes to both companies and universities.

The patenting of genes made it impossible for other competing companies who could test for the gene technically to do so.  In other words, it artificially created a sole supplier situation where only one company could provide the test for that gene, and therefore could set the price wherever they wanted.  Jolie revealed that the cost of screening for those two genes alone was $3000, a cost prohibitive to many women.  However, the actual cost of the testing is significantly less.  I was wondering just how much less, then the answer arrived in my inbox.

I know that Gene by Gene, through its division, DNA Traits has the capability to offer this test and has been selling it internationally since 2012.  Bennett Greenspan, president of Gene by Gene has discussed this with me privately, and how terribly it pained him not to be able to do this testing to help people within the US.  Bennett shared some pretty profound thoughts about the unfair situation this created.

I was just getting ready to call Bennett, when less than 6 hours after the Supreme Court decision, I received an e-mail from Gene by Gene, which contained the answer – $995.  So the actual cost to the American consumer is only about one third to one quarter of what they were being charged as a result of the patent.

Today’s Supreme Court decision is truly a victory for patients, consumers, researchers, women and all US citizens.  Below is the content of the e-mail I received from Gene by Gene announcing the ability for DNATraits to sell the BRCA test in the US.

dnatraits brca

In effort to increase access to potentially lifesaving BRCA1 and BRCA2 tests, DNATraits can now offer tests for $995, a fraction of the cost of similar tests prior to the court decision

HOUSTON — Jun. 13, 2013 – Thanks to today’s U.S. Supreme Court decision opening the door to greater access to genetic medicine by American patients and their health care providers, testing for genes specifically linked to breast, ovarian and other cancers will now be more widely available and at a lower cost than ever before.

DNATraits, a division of Houston-based genomics and genetics testing company Gene By Gene, Ltd., announced today that it will offer testing for the BRCA1 and BRCA2 genes in the United States for $995.  Prior to today’s unanimous Supreme Court ruling, when exorbitant licensing fees kept DNATraits and others from offering BRCA gene tests in the United States, the cost for such tests was around $4,000.

“We’re pleased to make this important testing more widely available and accessible in the United States,” said Gene By Gene President Bennett Greenspan.  “Our highly automated CLIA-registered lab and efficient processes enable us to make genetic and genomic testing more affordable and accessible to more individuals, in the U.S. and worldwide.  And that’s our company’s mission, in a nutshell.”

The company’s announcement about the tests, which gained national attention when actress Angelina Jolie courageously revealed in May that being a BRCA1 carrier was among the factors in her decision to have a preventive double mastectomy, comes after today’s Supreme Court ruling in “Association For Molecular Pathology v. Myriad Genetics.”

“We commend the Supreme Court for opening the door to greater technological innovation and access to genetic tools that promise to save and improve the quality of human lives in the United States,” Greenspan added.  “It’s critical that as an industry we are able to continue to engage in healthy competition to drive down the costs of these tests – because as more individuals have access to and undergo them, the more information we’ll have about many serious diseases that eventually may lead to cures.”

DNATraits has processed testing for the BRCA1 and BRCA2 genes for individuals living outside the U.S. since 2012.  Those genes are processed using traditional Sanger DNA sequencing, which is considered the gold standard for DNA analysis, at the company’s Genomic Research Center in Houston, a CLIA-registered lab which has processed more than 5 million discrete DNA tests from more than 700,000 individuals and organizations globally.

In addition to the BRCA gene tests, DNATraits offers a pre-natal array that covers 111 population specific diseases, as well as other not population-specific diseases, like Duchene Muscular Dystrophy.

Customer Inquiries

Individuals interested in learning more about either the BRCA1 or BRCA2 tests should ask their doctors for more information.  They and their health care providers can also visit the company’s website, www.dnatraits.com, or call (713) 868-1438 for more information.