April 5, 2011 | By Julie Samuels

Appeals Court Hears Argument in the "Breast Cancer Gene" Case

The Federal Circuit Court of Appeals in Washington, D.C. heard oral argument yesterday in the closely watched “breast cancer gene” patent case. At issue are two patents covering naturally occurring human genes that, when present, signal an increased likelihood of developing breast cancer. The ACLU and the Public Patent Foundation filed the lawsuit in May 2009, representing 150,000 geneticists, pathologists, and laboratory professionals; in March 2010, the district court found in the plaintiffs’ favor and invalidated the patents.

Because Myriad owned the patents, testing on these two genes could only take place in Myriad’s own labs – meaning that others could not develop tests on those genes, depriving women from alternative (and cheaper) tests. This is the result of a troubling trend of patenting genes, despite long-standing Supreme Court precedent that, in order to be eligible for a patent, an invention must have a "new or distinctive form, quality or property" and may not be a product of nature. The district court agreed with plaintiffs that isolated breast cancer genes – genes that naturally exist in some women – did not meet this standard and invalidated the two patents.

Defendants appealed that ruling and the Federal Circuit heard argument yesterday. It is unclear which way the Court will go (it’s also possible that the Federal Circuit could decide that plaintiffs lacked standing to even bring the suit), but there were some encouraging moments during oral argument. For example, Judge Kimberly A. Moore asked Myriad’s attorney:

Why isn't the ingenuity the process, as opposed to the resultant DNA which is in your body? Why isn't the ingenuity the process of extracting it, the process of figuring out what it's useful for? Why is the ingenuity the thing? I mean, God made it, man didn't make it.

The U.S. government weighed in on behalf of plaintiffs, pointing out that recognizing patents covering genes like the breast cancer gene could lead to efforts to patent other naturally occurring materials, such as lithium and uranium.

EFF will continue to follow this case closely. Like the patents EFF has challenged, the breast cancer gene patents are symptoms of a broken patent system that too often stifles innovation rather than fostering it. What is worse, these patents limit access to potentially life-saving testing and treatment. We hope the Federal Circuit does its part to put the system back on track by affirming the district court's decision...

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