At the same time, the ruling held out hope for industry that certain research methods and the creation of synthetic DNA can be protected and thus worth the investment.
“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park of the American Civil Liberties Union, which represented doctors, researchers and cancer patients who brought the challenge.
“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 issue received national attention last month when actress Angelina Jolie revealed that she had a double mastectomy because genetic testing showed she carried a defective gene that greatly increased her chance for cancer.
The ruling was a split decision for Myriad Genetics Inc., which holds patents on genes that have been linked to breast and ovarian cancer and thus is the only company that offers the genetic tests, which can cost more than $3,000.
Justice Clarence Thomas, writing for the court, said that merely isolating those specific genes — BRCA1 and BRCA2 — was not worthy of a patent. The decision was a departure from decades of decisions to the contrary from the U.S. Patent and Trademark Office.
“Myriad did not create anything,” Thomas wrote. “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.”
He added that “groundbreaking, innovative, or even brilliant discovery does not by itself” overcome the fact that “laws of nature, natural phenomena, and abstract ideas” are beyond the domain of patent protection.
On the other hand, Thomas wrote, when Myriad and others create a synthetic form of DNA — called cDNA and particularly useful in conducting experiments and tests, such as cancer screening — their work does deserve patent protection.
“The lab technician unquestionably creates something new when cDNA is made,” he wrote.
Myriad focused on that part of the decision.
“We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” Peter D. Meldrum, the company’s president and chief executive, said in a statement. “More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall healthcare costs.”
The average American woman has a 12 to 13 percent chance of developing breast cancer, according to the court’s opinion, but mutations in the two genes isolated by Myriad increase the risk to as much as 80 percent for breast cancer and 50 percent for ovarian cancer. Myriad developed tests useful in detecting those mutations.