Ambry fires back at Myriad with antitrust suit

Myriad Genetics ($MYGN) is using its legal budget and a misguided understanding of the law to monopolize the world of BRCA testing, according to a lawsuit from rival Ambry Genetics, the latest shot in a patent dispute with deep implications for the diagnostics industry.

In its suit, Ambry alleges that Myriad is violating the Sherman Antitrust Act in its attempt to stop competitors from offering analysis of BRCA1 and BRCA2 genes, clinging to claims already invalidated by the Supreme Court.

Back in June, the high court nullified 5 of Myriad's patents on isolated genes, including two BRCA mutations, spurring Ambry and Houston's Gene By Gene to launch BRCA tests of their own. Last month, Myriad filed suits against the two companies, alleging that they violated patents related to the testing process, not individual genes.

That amounts to illegal anticompetitive conduct, Ambry said, arguing that Myriad's claims are plainly invalid and clearly designed to further its monopoly. Separately, Myriad has been falsely representing the quality of Ambry's tests to payers and genetic counselors, Ambry CEO Charles Dunlop said, all part of Myriad's effort to trump up its monopoly-priced products.

"Being sued for patent infringement a month after the Supreme Court ruled 9-0 unanimously against Myriad is just wrong," Dunlop said in a statement. "Tactics like this have no place in the medical field, especially cancer, as it will take a collaborative, industry-wide effort to further understand the disease and find cures."

Myriad maintains that its claims are sound, saying it looks forward to making the case in court that Ambry infringed patents on synthetic primers, probes, arrays and testing methods related to the two genes.

"We believe we have a strong case based on the evidence and that Ambry's counter claims are without merit," the company said in a statement. "The claims at issue in this case are not the same as those in the Supreme Court case, which was a separate matter."

In the original lawsuit, Myriad and four others alleged that Ambry violated 10 patents that cover how BRCA1 and BRCA2 are analyzed, demanding a jury trial in which it would ask for monetary compensation and an injunction on Ambry's sales of the 5 tests it launched after the June ruling. The suit against Gene By Gene is virtually identical.

If Myriad and its co-plaintiffs win out, many in the industry are concerned it could gut the Supreme Court's initial intent. Myriad no longer has patents on the actual BRCA gene, but, as The Washington Post's Timothy Lee noted last month, if its broad claims on isolating and sequencing that gene are upheld, it may as well own the thing.

Ambry, of course, contends that those process claims are invalid and that the June ruling went far enough. In a column for FierceMedicalDevices last month, Senior Vice President Ardy Arianpour wrote: "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."

- read Ambry's announcement
- check out the lawsuit (PDF)

Editor's note: This story has been updated to include a statement from Myriad Genetics.