WASHINGTON: Naturally occurring human gene sequences cannot be patented but artificially copied and replicated DNA can be, the US Supreme Court ruled unanimously on Thursday.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated but cDNA is patent eligible because it is not naturally occurring,” the court ruled.
The nine justices issued the ruling after reviewing a 2012 appeals court decision that allowed biotechnology company Myriad Genetics Inc to patent two genes it found had links to breast and ovarian cancer, BRCA1 and BRCA2.
US actress Angelina Jolie recently underwent a double mastectomy as a preventative measure after discovering she had a mutation in one such gene and was thus at greater risk of developing breast cancer.
A coalition of associations representing some 150,000 researchers, doctors and patients, asked the nation’s top court to overturn the decision, as it stopped them from doing further work and research with the patented genes.
The ruling represents a victory for the scientific community.
“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, senior staff attorney with the American Civil Liberties Union, welcoming the decision.
Myriad offers testing for the two genes, whose discovery in the 1990s were the product of research that typically requires years of effort and large investments.
Myriad “found an important and useful gene, but groundbreaking, innovative or even brilliant discovery does not by itself satisfy” the Patent Act, the decision said.
But the ruling was also seen as a partial victory for Myriad, whose shares jumped on the news, as it was able to retain patents on other gene patterns that fall under the cDNA definition.
“The Supreme Court has ruled, vacating some patent claims and upholding others,” Myriad posted on its Facebook page.
“But we’ve always said the debate was about more than patent claims. It was about human health, and innovation to make sure that cancer tests are accessible and affordable to women who need them.
Researchers have previously been unable to develop competing tests that may potentially be more effective than Myriad’s to determine if a women is a carrier of the mutations that predispose her to breast or ovarian cancer.
Lisbeth Ceriani, a breast cancer survivor and plaintiff in the case, was faced with having to pay more than $4,000 for Myriad’s testing after Myriad refused to enter into a contract with her insurance company.
She waited 18 months before she was able to obtain the test through a grant, 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.”
Nearly 20 percent of identified human genes are currently under patent, some of which are associated with Alzheimer’s disease or other cancers.
These patents are sometimes owned by private companies but also by universities and research institutes concerned with keeping them in the public domain to prevent companies from seizing them.
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