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ACLU, PubPat Seek Supreme Court Review of Myriad Lawsuit

NEW YORK (GenomeWeb News) – The American Civil Liberties Union and the Public Patent Foundation have petitioned the US Supreme Court to hear their case against Myriad Genetics, which seeks to invalidate patents on the BRCA1 and BRCA2 genes that are licensed by Myriad.

ACLU and PubPat's move to take the case to the high court was not unexpected, as GenomeWeb Daily News reported in October that they would seek a Supreme Court decision after the Federal Circuit Court of Appeals – which recently supported Myriad's right to hold the patents – decided not to rehear the case.

"We are asking the Court to rule that patent law cannot impede the rights of scientists and doctors to conduct their research and exchange ideas freely," Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project, said in a statement. "Something as natural as human DNA cannot be owned by a particular company."

The case, American Molecular Pathology et al. v. US Patent and Trademark Office et al., got its start in a New York federal district court in late 2009. The most recent appeals court decided in August that isolated gene sequences in patents held by the University of Utah and licensed by Myriad are not products of nature and therefore are patentable, a ruling that overturned the district court's decision. The appeals court's decision effectively said that companies can hold patents on genes, but it invalidated patents on methods of comparing genes.

PubPat and the ACLU say that the patents and license agreements giving Myriad exclusive rights to perform diagnostic tests on the BRCA1 and BRCA2 genes allow the company to control the diagnostic care provided to patients and create a monopoly in which Myriad sets the terms and costs of the tests and makes it impossible for women to get second opinions or alternate tests.

When the appeals court ruled to uphold Myriad's patents in July, the company's President and CEO Peter Meldrum said that the decision "is in the best interests of the agriculture, biotechnology, and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection."

ACLU and PubPat see gene patents as being different in nature from most biotechnology patents.

"Nobody 'invents' genes, so no one should be able to claim ownership of them," said Daniel Ravicher, executive director of PubPat and co-counsel in the lawsuit. "We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented."

Yesterday, the Supreme Court heard oral arguments in the case of Mayo Collaborative Services v. Prometheus Laboratories, and the decision in that case could potentially impact Myriad's method claims at the center of this dispute.