Washingtion: Myriad Genetics Inc., a provider of tests for breast-cancer risk, on Tuesday sued to shut down a competitor that set up shop last month after a mixed US Supreme Court ruling on patenting human genes.
Ambry Genetics Corp., a closely held clinical laboratory in Aliso Viejo, California, said on 13 June it would offer the breast and ovarian cancer tests hours after a high court ruling that invalidated some of Myriad’s patents on genes linked to the diseases.
Myriad said Ambry’s tests infringe 10 other patents it owns or licences on the testing process, which wasn’t part of the Supreme Court case. The other owners of the patents—the University of Utah, the University of Pennsylvania, the Hospital for Sick Children in Toronto and Endorecherche Inc.—also joined in the suit against Ambry.
“They are clearly using the same processes we are using in our testing,” Richard Marsh, Salt Lake City-based Myriad’s general counsel, said in an interview. “They are infringing the claims of our patents in the way they are doing their testing.”
In a regulatory filing, Myriad said the patent owners would seek an order to prevent Ambry from offering its BRCAplus, BreastNext, OvaNext and CancerNext tests while the case is pending. Humberto Huerta, a spokesman for Ambry, didn’t immediately respond to messages seeking comment on the lawsuit.
Ambry’s test will reduce Myriad’s diagnostic revenue, which in turn will mean lower royalty payments for the patent owners, according to the complaint. It seeks compensation and an order that Ambry provide to the patent owners, including Myriad, all products that infringe the patents so they can be destroyed.
“Myriad pays 8% of its test revenue to the four patent owners, or about $57 million so far, and the amount will rise as the test becomes more widely used,” said Ron Rogers, a company spokesman. Public awareness of the tests has grown since Academy Award-winning actress Angelina Jolie said in May that she had a double mastectomy after Myriad tests showed she had the mutation linked to the cancer that killed her mother at 56.
The patent owners have been damaged and have suffered irreparable injury due to the defendant’s acts of infringement, and will continue to suffer irreparable injury unless stopped by the court, Myriad and the owners said in the complaint.
The Supreme Court case dealt only with whether certain gene-related patents improperly covered natural phenomena, and said certain types of human genetic material could be patented as long as there is sufficient intervention by people.
The ruling made clear that applications using knowledge of the genes were eligible for legal protection, and it’s those types of patent claims that are the subject of the federal complaint filed Tuesday in Utah.
“It’s like any other company that’s got a patent portfolio: you would expect them to protect it,” Amanda Murphy, a William Blair and Co. analyst in Chicago, said by telephone.
Myriad has a database of 16,000 gene mutations that gives the company a pretty meaningful advantage over competitors relying on less rich public information.
“Some of the labs have talked about kind of competing on price in order to gain market share,” Murphy said. “I find it difficult to understand how a doctor would use a test that has a lower level of sensitivity than a Myriad test.”
Myriad has been criticized for charging $3,000 for its tests and for its past efforts to prevent others from creating a competing exam.
“This is more of Myriad’s arrogant monopolist behaviour that is so harmful to patients, science and health-care costs,” said Dan Ravicher, president of the New York-based Public Patent Foundation which, along with the American Civil Liberties Union, represented the challengers in the Supreme Court case.
“This is just an attempt to save face with Wall Street, so they can keep up their story that they have a viable moat around their business, which they do not,” he said.
Myriad pledged that it wouldn’t curb any non-commercial research into the subject genes, nor would it interfere with the ability to get a second opinion, in a statement today.
The company also said it has various programmes to ensure affordable access to tests for all those in need, and many people will be able to get them for free once provisions of the federal Affordable Care Act take effect.
Myriad has invested more than $500 million to create a diagnostic test for hereditary breast and ovarian cancer cases related to the genes it discovered, which are known as BRCA1 and BRCA2, the company said in the complaint.
The efforts have revolutionized patient care and provided medical diagnosis and treatment options never thought possible, Myriad said in the complaint.
Myriad owns five of the patents and is exclusive licensee of the other five. Elements of three of the licensed patents were part of the civil court challenge; not all aspects of the patents were part of that case and remain in force.
The case is University of Utah Research Foundation v. Ambry Genetics, 13-640, US District Court for the District of Utah. BLOOMBERG
Alex Wayne and Greg Stohr in Washington and Robert Langreth and Shannon Pettypiece in New York contributed to this story.