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Gene patent case ramps up

Today the American Civil Liberties Union (ACLU) and others file legal documents challenging patents on DNA.

The ACLU briefs detail their case against seven patents held by Myriad Genetics, a diagnostics company based in Salt Lake City, Utah, regarding two genes associated with a high risk of breast and ovarian cancer, BRCA1 and BRCA2.

On 20 July, the ACLU and the Public Patent Foundation will argue the case in front of a judge at the federal appeals court in Washington DC, on behalf of patients, investigators and doctors.

It’s a flashback to 2011, when Myriad won this battle. The case was revived in March when the supreme court ruled that patents on a blood test from the California-based diagnostics company Prometheus Laboratories were invalid because they simply reflected ‘a law of nature’. Specifically, the test measures components in a person’s blood to determine correct drug dosing.

The ruling against Prometheus’s patents “reinvigorated our concern that there are too many patents on natural phenomenon”, says Sandra Park, an ACLU attorney representing the plaintiffs. “That’s what we’ve been arguing all along, but now that the court has reiterated it, we are arguing that this supreme court doctrine that prohibits the patenting of laws and products of nature needs to be taken more seriously.”

The debate centres on whether DNA extracted and amplified from patients is a product of nature. The ACLU says that it is, but Myriad argues that isolated DNA is structurally and functionally different than DNA within a person, and therefore patentable because it is no longer a product of nature.

In its briefs, the ACLU also fights against Myriad’s patents over certain methods. Specifically, the company put a patent on their protocol to predict how patients with BRCA mutations will react to cancer drugs. In it, they compare how cells with and without the BRCA mutations grow in response treatments. The patent claim means that Myriad can stop investigators from using that method in their research. Park says that patent should also be invalid because it “monopolizes a law of nature”.

This case packs a punch because several companies own genes, and many more plan to do the same. Biotech companies argue that if DNA cannot be patented, there is little incentive to invest money in developing genetic tests. On the other side, investigators and patients argue that the patents ultimately stifle research and limit patients’ testing options.


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