The American Civil Liberties Union has asked for a second time that the Supreme Court invalidate Myriad Genetics Inc.'s patents on two genes associated with hereditary breast and ovarian cancers, the latest salvo in a case with broad consequences for the future of gene-based medicine.
The lawsuit against Myriad and the University of Utah Research Foundation, which hold patents that allow the company to control testing for the genes, alleges that the patents are illegal and restrict scientific research and patients' access to medical care.
The lawsuit was filed by the ACLU and the Public Patent Foundation on behalf of medical associations, geneticists, patients and breast cancer and women's health groups, the ACLU said Tuesday.
The Supreme Court had sent back the ACLU's previous lawsuit to the U.S. Court of Appeals for the District of Columbia Circuit. It asked the appeals court to reconsider a decision upholding the patents in light of a March decision by the high court that rejected a similar case about a patented method for monitoring a patient's blood.
However, by a 2-1 vote, the appeals court in August again ruled that companies can obtain patents on genes.
The Supreme Court will likely give Myriad a chance to respond before deciding whether to hear the case or let the appeals court ruling stand.
"In our view, the Court of Appeals did not fully consider or correctly apply the Supreme Court's most recent and relevant patent law decisions," ACLU attorney Chris Hansen said in a statement.
Myriad did not immediately return phone calls seeking comment on the ACLU action. Corporate patent owners have argued that important research could be stifled if there is no legal recognition and protection of the scientific ingenuity involved in the discovery of genetic mutations like the ones at issue in this case.
The genes in question, known as BRCA1 and BRCA2, can be used to detect risk of breast and ovarian cancer and to help inform treatment options. Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of developing breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.
The patents give Myriad exclusive rights to perform tests on the two genes. The ACLU lawsuit contends that the exclusivity allows Myriad to set the cost of such testing and makes it impossible for women to access tests that provide more comprehensive information about their genes or get a second opinion about their results. The ACLU also contends that the exclusivity prevents researchers from even looking at the genes without getting permission from Myriad.
Lawrence Sung, a professor and director of the intellectual property law program at the University of Maryland School of Law, said 30 years of patent law could be upset if the appellate decision is reversed, and investment in biotechnology could take a hit if the Supreme Court indicated it would hear the case. But he noted that the justices had declined to take up the case once before.
"There's a real crying need for clarification about patent law and intellectual property related to genomics," said Jeffrey Kahn, a professor of bioethics and public policy at the Johns Hopkins University.
He suggested that research has suffered because of the uncertainty created by Myriad and other companies enforcing patents on genetic material. Some scientists are less likely to share their findings for fear they'll run afoul of patent claims, Kahn said.
Baltimore Sun reporter Timothy B. Wheeler and Reuters contributed to this article.
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