An Israeli researcher has developed a new method of testing for genetic mutations known to pose a heightened risk of breast cancer, possibly undercutting a long-running legal battle over gene patents developed at the University of Utah just as that fight heads to the U.S. Supreme Court.
The researcher, Asher Y. Salmon, a breast-cancer specialist at the Hadassah Hebrew University Medical Center, in Jerusalem, said his method tests for the functioning of the BRCA1 and BRCA2 genes rather reading their actual genetic code.
Breast cancer kills more than 40,000 women in the United States annually, and a private company, Myriad Genetics Inc., has claimed an exclusive right to use technology developed at the University of Utah to identify defects in the BRCA1 and BRCA2 genes that are associated with the disease.
Citizens’ rights groups in the United States have been waging a court battle against Myriad Genetics’ claim since 2009, saying a company has no right to patent a natural part of the human body. The Supreme Court recently agreed to hear the case.
Now Dr. Salmon says he believes his discovery will give patients a lower-cost alternative cancer-screening method, regardless of the outcome of the court case.
“This test is using a totally different technique” than gene sequencing used by Myriad Genetics, Dr. Salmon said. “There is no claim for Myriad here.”
Myriad Genetics tests for a propensity to develop breast cancer or ovarian cancer by comparing a patient’s BRCA1 and BRCA2 genes with known variations associated with cancer.
In the most recent ruling in the case, in August, a federal appeals court sided with Myriad Genetics, which has argued that the isolated genes it uses for comparisons in its testing process are sufficiently different from genes in the body to allow the company a patent.
The company’s opponents in the case are led by the Public Patent Foundation and the American Civil Liberties Union, which contend that the genes are a form of nature that cannot be patented, and that such restrictions harm medical research and patient care.
Dr. Salmon, in a report published this week in Cancer Prevention Research, a journal of the American Association for Cancer Research, said his approach involves comparisons of the chemical signatures of 21 other genes where variations also appear to show an elevated risk of cancer.
Officials at Myriad and the University of Utah Research Foundation, which holds the patents on the BRCA genes, declined to discuss the implications of Dr. Salmon’s technology.
A Myriad spokesman, Scott Gleason, provided a written response in which he said the company had not had time to evaluate the technology, “but would note that it is very early stage and will require extensive validation and commercialization work before it is market ready.”
Expiring Patents
Kevin E. Noonan, a patent lawyer with experience in representing pharmaceutical companies and universities in patenting and licensing cases, said the technical description provided by Dr. Salmon does seem to suggest he has found an alternative method of assessing cancer risk without violating Myriad’s patent rights, even if the Supreme Court backs the company.
“They figured out a way to assay something else to get the same answer,” Mr. Noonan, a partner at McDonnell Boehnen Hulbert and Berghoff LLP, said of Dr. Salmon and his team.
If validated, the approach by Dr. Salmon would mean some advantages for patients, Mr. Noonan said. The Myriad test costs about $3,000 to $4,000 per patient, while Dr. Salmon estimates his procedure—without the need for expensive gene-sequencing technology—could be made available commercially for about $100 per test.
But Myriad has claimed its test never gives a false negative, meaning it detects every mutation, with the ability to identify the significance of the mutation in 98 percent of the instances. Dr. Salmon’s report describes its method as being 95 percent accurate, meaning some patients could get a false assurance of no elevated risk.
Still, Dr. Salmon said, that may be better than the alternative for many patients who simply cannot afford the cost of Myriad’s test. The potential competition, as well as continuing advances in gene-sequencing technology, could lead Myriad to reduce its price, Mr. Noonan said.
Regardless, the court case is slowly losing its relevance for Myriad, Mr. Noonan said. That’s because the patent protections at issue are due to expire in about two years, and even if Myriad loses the court case, it still has the competitive advantage gained from 15 years of administering and interpreting the tests, he said.
The importance of owning the patent right to the code associated with a human gene may also be losing a race against time, he said, because scientists are increasingly focusing on just the parts of the gene that are associated with a particular condition.
“I’ve never seen a gene claim being asserted in a way that if all you’re making is a piece of it, that that would be infringing,” he said.