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Ambry Genetics Countersues Myriad Genetics Alleging Antitrust Violations

NEW YORK (GenomeWeb News) – In response to Myriad Genetics' patent infringement lawsuit against Ambry Genetics, the Aliso Viejo, Calif.-based testing firm took its own legal action today by countersuing Myriad for antitrust violations.

"Myriad's lawsuit is in violation of the Sherman Antitrust Act because the asserted claims against Ambry are invalid under two [US] Supreme Court decisions and Federal Circuit authority," the company said in a statement.

In July, shortly after the Supreme Court invalidated several of Myriad's patent claims on isolated BRCA1/2 gene sequences, the company and other assignees to several patents underlying the BRACAnalysis test filed a patent infringement lawsuit in the US District Court for the District of Utah against Ambry Genetics. The patent holders allege that Ambry's testing process for gauging mutations in BRCA1 and BRCA2 associated with breast and ovarian cancer risk infringe claims in 10 patents owned or licensed by them.

Although the Supreme Court invalidated a number of Myriad's patent claims on isolated gene sequences and a lower federal circuit court ruling invalidated several broad method claims on the BRACAnalysis test, Myriad has asserted that it still holds 500 valid and enforceable claims in 24 patents. In fact, the Supreme Court upheld a number of cDNA claims and emphasized in the ruling that novel applications of the knowledge of gene-disease associations are still patent eligible. The ruling has resulted in some confusion in the life sciences industry as to the specific types of diagnostics method patents that are still valid.

Before the Supreme Court's decision, Myriad had been the only diagnostics company for nearly two decades offering BRCA testing for gauging hereditary breast and ovarian cancer risk. After the court's ruling, Ambry was the first company to launch BRCA testing. In its countersuit, Ambry asserts that Myriad doesn't have a legal basis to stop it from performing such testing.

"Myriad continues a practice of using overreaching practices to wrongfully monopolize the diagnostic testing of humans' BRCA1 and BRCA2 genes in the US and to attempt to injure any competitor who challenges Myriad's monopoly, including Ambry," the company said in a statement. "This includes conduct by Myriad of falsely representing to genetic counselors and payors as to the accuracy of Ambry's BRCA1 and BRCA2 diagnostic products."

According to Ambry, Myriad is "wrongfully depicting" the rate of variants of unknown significance for Ambry's tests to be as high as 30 percent, when "it actually is approximately 5 percent" for BRCA1/2 diagnostic testing. "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," the company stated.

Ambry alleges that Myriad's anticompetitive practices have increased the price of BRCA testing. The company claims that Myriad's BRACAnalysis test – priced at between $3,000 to $4,000 – is twice as high as the price of Ambry's products and other competitors.

In its suit against Ambry, Myriad and other patent assignees allege that several of the Ambry's tests – BRCAplus, BreastNext, OvaNext and CancerNext tests – infringe their patent claims. Shortly after Myriad sued Ambry in July, the company sued Gene by Gene, another company that began offering BRCA testing following the Supreme Court's decision, in a similar lawsuit.

"Myriad's illegal enforcement of the asserted patents has ensured that customers have virtually nowhere to turn but Myriad and its monopoly-priced products," the company said in a statement.

"We are in the early stages of the litigation with Ambry and look forward to presenting our case in court," Myriad said in a statement sent to GenomeWeb Daily News this morning. "The BRCA patent owners will demonstrate that the testing process employed by Ambry infringes 10 patents covering synthetic primers, probes and arrays, as well as methods of testing, related to the BRCA1 and BRCA2 genes.

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

Meanwhile, Myriad recently expanded its financial assistance program, through which patients who qualify under the income requirements and meet the guidelines for testing will have to pay no more than $375 for its tests in out-of-pocket costs. It also noted today that it "offers free testing or financial assistance depending on a patient's level of need," and "patients' average out-of-pocket costs are less than $100."

According to Myriad, more than 35,000 patients to date have received assistance from the company to help pay for diagnostic testing.

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