WASHINGTON (Reuters) - Myriad Genetics’ disputed patent on the BRCA1 breast cancer gene is “surprisingly broad” and could interfere with future research, three experts said on Tuesday.
Their ongoing research indicates some other gene patents are similarly extensive, covering stretches of DNA that have nothing to do with the targeted genes, they reported in the journal Genomics.
“We find that, through this claim, the patent extends to portions of most genes in the human genome and likely to most genes in nature as well,” Thomas Kepler, Colin Crossman and Robert Cook-Deegan of Duke University in North Carolina wrote.
A federal court in New York is currently hearing a lawsuit filed by the American Civil Liberties Union against Myriad that seeks to have gene patents declared unconstitutional. And an advisory committee to the U.S. Health and Human Services Department is preparing recommendations on broad DNA patents.
Myriad’s Mark Skolnick and 10 collaborators won a patent on the BRCA1 gene in 1998.
“Mutations in BRCA1 confer a substantial risk for breast and ovarian cancers, with a cumulative risk of incidence by age 70 of 69 percent (breast) and 39 percent (ovarian),” the researchers wrote.
“Genetic tests to screen for these mutations in the United States are available exclusively through Myriad Genetics, the assignee of the patent.”
Some groups have protested that patenting human DNA is immoral and unethical and the Duke researchers suggested it is more difficult to do than previously thought.
For instance, BRCA1 is on chromosome 17. But long stretches of DNA on chromosome 1 are identical to stretches in the Myriad patent, the researchers said.
“This claim and others like it turn out, on examination, to be surprisingly broad, and if enforced would have substantial implications for medical practice and scientific research,” they wrote.
Richard Marsh, executive vice president and general counsel for Myriad, said he doubted the study would have any impact on the company.
“This issue is not before the court,” Marsh said in a telephone interview. “In terms of its impact or relevance to the existing lawsuit, it has no relevance.”
Marsh said Congress should decide the issue.
According to the Hastings Center, a bioethics research organization, as many as 5,000 patents have been made on human genes and 47,000 patents have been granted on inventions that involve genetic material.
It could be months before the judge at the Manhattan federal court issues a ruling on the Myriad case.
Editing by Eric Walsh