U.S. Supreme Court Rules Human Genes Can’t Be Patented, May Reduce Cost of Genetic Testing

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On June 13, 2013, the U.S. Supreme Court ruled unanimously that human genes can’t be patented.

The case was about patents held by Myriad Genetics, the Utah company that has held patents on the BRCA1 and BRCA2 genes for more than a decade. Right now, Myriad makes the only U.S. test for abnormal BRCA1 or BRCA2 genes. The test costs roughly $3,000. A group of scientists and patients challenged Myriad’s right to have patents on something that occurs naturally.

Everyone has BRCA1 and BRCA2 genes (BReast CAncer gene one and BReast CAncer gene two). The function of BRCA genes is to repair cell damage and keep breast cells growing normally. But when these genes are abnormal and are passed from generation to generation, they don’t function normally and breast cancer risk increases. Abnormal BRCA1 and BRCA2 genes may account for up to 10% of all breast cancers. Women with an abnormal BRCA1 or BRCA2 gene can have up to an 80% risk of being diagnosed with breast cancer; they also have a higher risk of ovarian, colon, pancreatic, and thyroid cancers, as well as melanoma.

Many people were concerned that Myriad’s exclusive rights to the BRCA genes was stopping scientists from developing more effective and cheaper ways to test for abnormal BRCA1 and BRCA2 genes, as well as limiting development of new treatments.

Others were upset that Myriad’s patent meant that only one BRCA gene test was available, so there was no opportunity for a second opinion.

Myriad said that it needed the patent on the BRCA genes to attract investors and enough funding to pay for the extremely high costs of bringing the BRCA test to market. The company said that the average cost of bringing a new medicine or test to the market is about $1.2 billion. Myriad was concerned that if the business of developing genetic tests isn’t profitable, new discoveries and innovations won’t happen.

After the Supreme Court ruling, many now believe that less costly genetic testing will soon be available. Indeed, according to the New York Times, at least three companies and two university labs said they would begin offering breast cancer genetic testing.

In its decision, the Supreme Court made a distinction between what it called “natural DNA” and “complementary DNA (or cDNA)” – synthetically created combinations of DNA that don’t exist naturally. cDNA is allowed to be patented.

So what does this mean for you?

It’s likely that many more companies will begin offering BRCA testing and that prices for the test will drop. It also means that if you have a BRCA test and the results are unclear, you’ll probably be able to have a second, different BRCA test to see if the results are confirmed. All of this is excellent news for anyone who’s been diagnosed with breast cancer or for people who haven’t been diagnosed but have family members who have been.

Still, the Supreme Court’s ruling does raise other issues and questions:

  • Based on the results of its BRCA tests, Myriad has created databases of information on how to interpret the test, as well as other abnormal genes that may be linked to breast cancer risk. Myriad doesn’t have to share this information with other companies. If they do decide to share the data, will they charge for it? How much will they charge? Will not having this data affect how other companies interpret test results?
  • As new BRCA tests are developed, will insurance companies cover only the least expensive version of the test?

Breastcancer.org will continue to follow this story and report on the continuing consequences of the Supreme Court’s ruling.

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