The U.S. Supreme Court ruled unanimously Thursday that human genes cannot be patented, a victory for "patient care and medical innovation," that will allow greater access to genetic testing and more affordable treatment for cancer patients, the American Civil Liberties Union said today.
The court decision invalidated patents on two genes associated with hereditary breast and ovarian cancer in response to a lawsuit filed by the ACLU and the Public Patent Foundation (PUBPAT) on behalf of women's health groups and thousands of researchers, health professionals and patients.
The case concerned patents on human genes held by Myriad Genetics, a Utah based corporation, on human genes that are tied to the risk of hereditary breast and ovarian cancer—an issue that received public attention in May when actress Angelina Jolie revealed she had a preventive double mastectomy. The news spawned debate over the procedure that is out of reach for most patients because of the extremely high costs related to Myriad's monopoly over the genes.
Myriad's patents had allowed them to set the terms and cost of testing the genes and "made it difficult for women to access alternate tests or get a comprehensive second opinion about their results," the ACLU explains.
The patents allowed a Utah company, Myriad Genetics, to control access to the genes, known as BRCA1 and BRCA2, thereby giving them the right to limit others from doing research or diagnostic testing of the genes, which can be crucial for individuals making important medical decisions.
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the ACLU Women's Rights Project. "Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued."
The decision is a major shift in patent law pertaining to human biology and declares that all the patents on human genes are invalid.
Justice Clarence Thomas, who wrote the court’s decision, stated:
“We hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."
"The court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA," said Daniel B. Ravicher, executive director of PUBPAT and co-counsel in the lawsuit.
"I'm relieved that no other women will have to go through what I went through," said Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, who was faced with having to pay over $4,000 for Myriad’s testing. "I'm so glad that the Supreme Court agrees that women deserve full access to vital information from their own bodies."
The court did, however, rule that "synthetically produced genetic material" could be patented as opposed to genes extracted from the human body, known as isolated DNA.