A U.S. federal appeals court has affirmed the right of Myriad Genetics to patent two human genes that form the basis of a widely used genetic test for breast and ovarian cancers.
The ruling on Friday from a U.S. federal appeals court in New York reverses a lower court decision and backs the company's right to patent two "isolated" human genes — BRCA1 and BRCA2 — that account for most inherited forms of breast and ovarian cancers.
Women who test positive using Myriad's gene test, called BRACAnalysis, have an 82 percent higher risk of breast cancer and a 44 percent higher risk of ovarian cancer in their lifetimes.
Some groups have protested that patenting human DNA is immoral and unethical. But attorneys representing biotechnology companies expressed relief, saying the lower court's decision, if left standing, could have been potentially devastating to the industry.
The lawsuit filed by the American Civil Liberties Union against Myriad had sought to have gene patents revoked.
But the appeals court said the genes isolated by the company can be patented because Myriad is testing for distinctive chemical forms of the genes, and not as they appear naturally in the body.
The court also affirmed patents for the company's screening process, which is based on changes in cell growth rates, but said Myriad did not have the right to patent its method of analyzing these genes, which is based largely on abstract, mental processes.
The decision covers two "isolated" human genes — BRCA1 and BRCA2 — and certain genetic changes or mutations in these genes that increase the risk of breast and ovarian cancers.
"The appeals court has now held that isolated DNA is patent eligible, and it recognized that isolated DNA has a different molecular structure than DNA as it exists in the body. That is a very significant result that is very important to the biotech industry," said Bruce Wexler, a partner in the law firm Paul Hastings which was not involved in the lawsuit but represents biotech clients.
Wexler said it is not clear whether the ACLU will appeal the decision to the U.S. Supreme Court, but at the moment, he said, "It's the law of the land in patents."
