The Supreme Court could decide whether human genes may be patented in a case involving Utah-based Myriad Gentics and the University of Utah.
The case the court added last week to its docket for a second time concerns patents Myriad licenses from the U. on genes that correlate with increased risk of hereditary breast and ovarian cancer.
The patents were challenged by scientists, doctors, cancer patients and women’s health advocates who said Myriad’s patents have stifled research and development of alternative diagnostic tests.
“Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person in the United States,” the plaintiffs, represented by the American Civil Liberties Union and the Public Patent Foundation, told the Supreme Court in their petition seeking review of a lower appeals court decision.
They added that the patents “prevent patients from examining their own genetic information” and “made it impossible to obtain second opinions.”
The legal question for the justices is whether genes isolated in a laboratory from their naturally occurring place in the body are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.
A divided three-judge panel of a U.S. appeals court in Washington ruled for the company. Each judge issued an opinion, and a central dispute was whether isolated genes are sufficiently different from ones in the body to allow them to be patented.
“The isolated DNA molecules before us are not found in nature,” wrote Judge Alan Lourie, who was in the majority. “They are obtained in the laboratory and are man-made, the product of human ingenuity.”
That was the second time the appeals court had ruled in Myriad’s favor. The Supreme Court previously sent that decision back to the judges for reconsideration in light of a ruling in another case.
This time around, Myriad urged the justices not to hear the case, saying that the “isolated molecules” at issue “were created by humans, do not occur in nature and have new and significant utilities not found in nature.”
It has long been settled, the company’s brief went on, that “the human ingenuity required to create isolated DNA molecules” is worthy of encouragement and that its fruits are worthy of protection.
The plaintiffs in the case were supported by friend-of-the-court briefs filed by the American Medical Association, AARP and women’s health groups.