Human genetic sequences cannot be patented, the U.S. Supreme Court ruled Thursday in an unexpected decision that is a tremendous public interest victory.
“Myriad [Genetics] did not create anything,” the Supreme Court held, in a lawsuit that challenged the firm’s monopoly on two gene sequences used in expensive tests that reveal whether women have an inherited risk of breast and ovarian cancer. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
The immediate impact gives other biotech firms the go-ahead to develop less-expensive DNA-based tests for the genetic risk of breast and ovarian cancer. Looking down the road, the ruling will force biotech companies to rethink their business models that have been based on ‘owning’ the building blocks of life.
“The Court rightfully found that patents cannot be awarded for something so fundamental to nature as DNA,” said Daniel B. Ravicher, Executive Director of the Public Patent Foundation, which lead the suit challenging two patents awarded for gene sequences tied to breast and ovarian cancer. “Bottom line, diagnostic genetic testing is now free from any patent threat, forever, and the poor can now have their genes tested as freely as the rich.”
Women’s health care advocates immediately hailed the Court’s decision, saying it put patients' health and scientific research ahead of private corporate profits.
“This ruling makes a huge and immediate difference to those with a known and suspected inherited risk of breast cancer,” said Karuna Kagger, executive director of Breast Cancer Action. “It is a tremendous victory for all people everywhere. The Supreme Court has taken a significant stand to limit the rights of companies to own human genes by striking down Myriad’s monopoly.”
“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, which was a co-counsel in the lawsuit. “Myriad did not invent the BCRA [breast and ovarian cancer] genes and should not control them.”
The public interest attorneys challenged two patents issued to Myriad Genetics, saying they created a monopoly that not only prevented women from getting less-costly breast and ovarian cancer tests and second medical opinions, but also restricted scientists from doing additional research on the gene sequences. Their lawsuit was filed on behalf of researchers, genetic counselors, patients, breast cancer and women's health groups, and medical associations representing 150,000 geneticists, pathologists, and scientific laboratory professionals.
The patents allowed Myriad Genetics, a Utah-based company, to control access to the genes, known as BRCA1 and BRCA2, which limited others from doing tests or research. The patents also allowed Myriad to set the terms and cost of testing. The firm argued that it needed the patents to protect hundreds of millions of dollars in research that lead to its tests. That argument was also made by other biotech firms, saying that without such monopolies that it would inhibit scientific research and medical breakthroughs.
The Court’s unanimous ruling, written by conservative Justice Clarence Thomas, found that the patents on human genes are invalid. That represents a major shift in law and overturns the current policy of the U.S. Trademark and Patent Office, which has issued more than 40,000 patents tied to genetic material since 1984. Delving into gene science, the Court found that patents on complementary DNA, or cDNA, however, are patent-eligible. But scientists can provide genetic testing without relying on cDNA, which lifted the patent obstacle to offering genetic diagnostic testing.
“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,” Park said.
The patent-based restrictions on examining the BRCA genes have had devastating results.
The public interest lawyers pointed to women such as Kathleen Maxian of Buffalo, N.Y., who is suffering from late-stage ovarian cancer that she believes could have been found and removed if Myriad’s patents did not stop labs for routinely looking for the cancers.
Lisbeth Ceriani, a breast cancer survivor and plaintiff, was faced with having to pay over $4,000 for Myriad’s testing to determine if she carried a genetic mutation associated with hereditary ovarian cancer because Myriad had refused to enter into a contract with her insurance company. She was forced to wait 18 months before being able to raise the funds to pay for the tests, at which point she learned she did indeed carry a mutation.
“I’m relieved that no other women will have to go through what I went through,” said Ceriani. “I’m so glad that the Supreme Court agrees that women deserve full access to vital information from their own bodies.”
Harry Ostrer, a medical geneticist who also was a plaintiff in the case, called the ruling “thrilling” and predicted that it would cut costs for breast and ovarian cancer screening, especially for low-income women and the uninsured.
“Ensuring equal access to genetic testing is one of the key aspects of this ruling,” he said.
The case was the first challenge brought to human gene patents in the U.S.
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