Justices Rule: No Patenting of Genes!

The US Supreme Court unanimously ruled this past week that human genes are “a product of nature” and cannot be patented, a landmark decision that scientists said could remove impediments to research and enhance patients’ ability to learn the disease risks that lurk in their DNA.

The ruling came in a challenge to patents that Utah-based biotechnology company Myriad Genetics Inc. holds on gene mutations that convey higher risks for breast and ovarian cancer. Those genes have recently been catapulted into the national spotlight by actress Angelina Jolie’s revelation that she had her breasts removed after discovering she had a high genetic risk of developing cancer.

Doctors and patients said they hoped the ruling would alter the genetic testing landscape, enticing new companies to offer tests for the cancer gene mutations and provide competition that might bring down the test’s cost, now about $3,300. The decision may also help clarify the situation for hospitals and genome sequencing companies that examine the full genome and provide information to patients about genes that have been patented.

“A naturally occurring DNA segment is a product of nature” and can’t be patented, Justice Clarence Thomas wrote on behalf of the court, which struck down five of Myriad’s claims for patent protection. Myriad did not create or alter either the genetic information encoded in the . . . genes or the genetic structure of the DNA. It found an important and useful gene, but ground-breaking, innovative, or even brilliant discovery does not by itself make the work patent eligible.”

Biotech companies argue that being able to patent genes is crucial to encourage innovation, but they downplayed any negative impact of the decision, because the court said patents could still be issued for a kind of synthetic DNA called cDNA, which is similar to genes.

Over the past two decades, the type of gene patents sought by companies has shifted, especially after the human genome project put gene sequences into the public domain. Patents now often focus on synthetic DNA forms.

Myriad Genetics holds patents on the BRCA1 and BRCA2 gene mutations that have been shown to increase the risk of breast and ovarian cancer. Patents are awarded for inventions and new ways of making things, and Myriad argued that pinpointing the location of mutated genes, and isolating and sequencing those genes, amounted to information that was eligible for patent protection. The court disagreed. Myriad’s leadership said the company still has strong patent protection for its breast cancer test, called the BRACAnalysis.

“The intellectual property landscape, candidly, in terms of the protection we have around our testing, hasn’t changed,” the company’s general counsel, Richard Marsh, said. The company’s stock closed Thursday at $32.06, down 6%.

The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of researchers, genetic counselors, patients, and medical professionals.