UPDATED: Myriad sues Ambry over cancer Dx patents

When the Supreme Court invalidated some of Myriad Genetics' ($MYGN) gene patent claims last month, a bevy of competitors rolled out similar cancer diagnostics of their own, but now Myriad summoned its legal dogs once more, suing Ambry Genetics on claims that it violated patents not covered by the ruling.

After the June 13 ruling, California-based Ambry launched its own tests for BRCA mutations that can lead to breast and ovarian cancers, Bloomberg reports, but Myriad and its intellectual property co-owners say Ambry's assays violate 10 patents spared from the court's action. Myriad is demanding a jury trial, seeking monetary compensation and for Ambry to hand over all of its allegedly infringing products so that they may be destroyed.

The Ambry lawsuit covers patents unrelated to the Supreme Court's ruling, Myriad spokesman Ron Rogers said, applying to the BRCA testing process and not individual gene expressions.

For its part, Ambry has no plans to stop selling the 5 tests it has launched since the June ruling.

"Ambry Genetics supports the Supreme Court's decision and will vigorously defend its position," CEO Charles Dunlop said in a statement. "We have had an overwhelming response from our clients seeking an alternative laboratory to perform BRCA testing, and Ambry is fully committed to supporting our clients and patients moving forward."

Ambry is among a handful of diagnostics outfits that have rolled out BRCA-related tests since Myriad's day at the high court, including Quest Diagnostics ($DGX) and GeneDx. However, it's unclear whether Myriad believes only Ambry's tests infringe on its IP or if the company is planning to come after each of the ruling's beneficiaries, and Rogers declined to comment on possible future litigation.

In a column for FierceMedicalDevices earlier this month, Ambry Senior Vice President Ardy Arianpour wrote that the court's ruling was a victory for the industry and for patients who for years had just one option for BRCA1 and BRCA2 testing. "With the stroke of a pen, the floodgates of competition have been opened, creating a positive competitive dynamic as assorted players vie to deliver the most cost-effective, reliable BRCA testing packages," Arianpour wrote.

In the suit, Myriad said it has spent upward of $500 million developing the tests in question, using 5 patents it owns and 5 it has licensed from University of Utah, University of Pennsylvania, Endorecherche and Ontario's Hospital for Sick Children, all of which have joined in the lawsuit, Bloomberg notes.

Ambry's tests will mean lost revenue for Myriad and lighter royalty payments for the others, according to the lawsuit, and the parties "have been damaged and have suffered irreparable injury due to the defendant's acts of infringement, and will continue to suffer irreparable injury" unless the court steps in, Myriad said. Myriad hands over 8% of its related profits to the other patent owners, which has amounted to $57 million over the life of the patents, Rogers said.

- here's the lawsuit (PDF)
- read the Bloomberg story
- check out Myriad's 8-K discussing the suit (PDF)

Industry Voices: SCOTUS decision on gene patenting: A win-win for (almost) everyone

Editor's note: This story has been updated to reflect comments from Myriad Genetics and Ambry Genetics.

Suggested Articles

In an SEC filing, Baxter International disclosed that it may have overstated its income over multiple years, inflating it by about $276 million.

The FDA has given Grail a green light to conduct the interventional study, and it has begun enrolling participants through the company’s R&D partners.

Coronavirus may not require a front-line battle yet in certain places, but it’s still taxing public health officials preparing for a potential crisis.