Now that the Supreme Court has ruled that merely isolating a DNA sequence does not make it eligible to patent, the question arises, What will happen to the crucially important data accumulated by an overly broad monopoly?

The answer to this question has implications for people who may have an inherited risk for breast and ovarian cancer and to the scientists who hope to use that data for life-saving decisions about cancer surgery.

For the past 15 years, Myriad Genetics of Salt Lake City, Utah, has performed more than a million diagnostic tests for mutations in two genes -- BRCA1 and BRCA2 -- that are associated with inherited risk of breast and ovarian cancer. The Supreme Court ruling means Myriad has enjoyed a 15-year monopoly far broader than it should have been. The company now faces a fateful decision about what to do with that data it collected as a monopolist.

Will Myriads data be kept as proprietary assets to give Myriad a leg up on the competition that has already arisen, with four companies announcing after the Courts decision they will introduce BRCA genetic testing? Or will Myriad share the data so others outside Myriad can know the basis for interpreting the tests?

Interpreting test results, regardless of what laboratory does the testing, depends crucially on access to data and objectively verifiable interpretation of test results. Data about test results and their clinical significance should be publicly available and objectively verifiable, not secreted in a proprietary database.

Women (and some men) sending their samples to Myriad were not told their data would be kept as trade secrets. When there was a legal presumption of patent-enforceable monopoly, it would not have mattered. But now it does.

Accumulating the data was perfectly legal; and exclusive rights are the very purpose of patents. Moreoever, there is no law against hoarding data of commercial value; indeed, state laws protect trade secrets.

But data about peoples cancer risk are not the same as the secret formula for Coca-Cola. If someone wants a cola, she can buy Pepsi or Diet Rite. But for the past 15 years, Myriad has offered the only commercial test for BRCA mutations in the United States. That means the data about BRCA mutations flowed to Myriad and there they stopped.

Now the Court has ruled that the data are not protected by patent. But the data remain in private hands, and that is wrong.

Just to be clear, Myriad does a good job of testing, and its prices are in line with other tests of similar type. Myriad reports results quickly and clearly. It has committed resources to educating women at risk and their doctors about its tests. It works with its customers to secure payment, so that the vast majority have at least the initial test covered by insurance or a health plan. And Myriad will even do free testing for families harboring mutations whose clinical significance is unknown and for some customers without health coverage (.5 percent of its tests have been done at no cost to customers).

Read more here:
Genetic Testing Company Should Free Data

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