NEW YORK, March 26, 2012 - The U.S. Supreme Court today set aside a ruling that allowed a company to patent two genes linked to breast and ovarian cancer and limit access to potentially life-saving genetic tests for at-risk women.
The American Civil Liberties Union and the Public Patent Foundation (PUBAT) have challenged the patents held by Myriad Genetics on the BRCA1 and BRCA2 genes, which the Court of Appeals for the Federal Circuit last year ruled were valid.
"In light of recent rulings from the court that mere laws of nature cannot be patented, we hope that the lower court will come to the correct conclusion this time around," said Chris Hansen, staff attorney with the ACLU Speech, Privacy and Technology Project. "It's inconceivable that a company can own a patent on something as naturally occurring as DNA."
With the judgment vacated, the case will be sent back to the same three-judge panel who issued the July decision. They can decide the next steps and the timeline for the case. The Federal Circuit can then issue a decision with the same or a different outcome.
"Nobody ‘invents' genes, so no one should be able to claim ownership of them," said Daniel B. 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."
The Supreme Court ordered the Federal Circuit to reconsider its decision in light of the high-court's ruling last week in Mayo Collaborative Services v. Prometheus, where the justices unanimously invalidated a patent on a medical test because it covered a "law of nature."
"Preventing the free flow of ideas regarding genetic testing is not only unlawful, it is dangerous to patients," said Sandra Park, staff attorney with the ACLU Women's Rights Project. "Women are staking their lives on the results of these tests. They deserve to have the best quality care. It is encouraging that the court has determined that the appellate court's decision requires further review."
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