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Myriad Files Lawsuit Against Ambry Genetics for Infringing Patent Claims Underlying BRCA Test

This article has been updated to include a response from Ambry.

NEW YORK (GenomeWeb News) – Myriad Genetics and other assignees to several patents underlying the BRACAnalysis test have 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.

The patent holders, including Myriad, University of Utah, University of Pennsylvania, the Hospital for Sick Children, and Endorecherche, are asking the court to issue a preliminary injunction to prevent Ambry, a molecular diagnostics and genomics services provider based in Aliso Viejo, Calif., from selling tests that they claim infringe the patent claims at issue.

According to documents filed by Myriad with the US Securities and Exchange Commission, the tests marketed by Ambry that allegedly infringe the patent claims include the BRCAplus, BreastNext, OvaNext and CancerNext tests. The patent holders are also seeking up to treble damages for any profits lost if the court finds that Ambry's infringement is willful.

The lawsuit comes a few weeks after the Supreme Court ruled that Myriad's patent claims on isolated BRCA sequences are products of nature and thus invalid under US patent law. However, in Association for Molecular Pathology et al v Myriad the court upheld several of Myriad's patent claims of complementary DNA synthesized in a lab and used as probes and primers in diagnostic testing.

Following the ruling, Myriad emphasized that it still had 500 valid and enforceable claims in 24 patents underlying its flagship BRACAnalysis test. However, until now, there was a lot of uncertainty and speculation as to whether Myriad would actually challenge diagnostics firms that rushed to offer testing for cancer-linked BRCA1/2 gene alterations.

Immediately after the Supreme Court released its decision, a number of labs announced that they would begin testing for BRCA alterations, including Ambry, GeneDx, Pathway Genomics, Gene by Gene, and the University of Washington. Quest Diagnostics has also expressed an interest in providing BRCA testing later this year.

In an article recently published in GenomeWeb Daily News sister publication Clinical Sequencing News, Ardy Arianpour, senior VP of business development at Ambry, said that the company had been waiting for a Supreme Court ruling that would allow the firm to launch BRCA testing in the US. The company had always included BRCA1 and BRCA2 on its cancer panels, but no analysis or reporting was ever performed.

Ambry's various tests gauge the BRCA gene sequence and assess deletions and duplications using Illumina's next-generation sequencing platforms, the HiSeq or the MiSeq. Myriad's legal action against Ambry raises questions about whether other labs are also facing similar litigation risk.

Myriad General Counsel Richard Marsh would not speculate on whether the company plans to take action against these other labs offering BRCA testing. (Myriad filed a suit against Gene by Gene on Wednesday afternoon.)

Spokesperson Ron Rogers emphasized that the lawsuit against Ambry is being brought by not just Myriad, but all the patent holders.

Ambry said today that it intends to vigorously defend itself against the patent infringement suit. It noted that it began offering BRCA1 and BRCA2 diagnostic testing following the US Supreme Court decision.

"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 CEO Charles Dunlop said in a statement released Wednesday afternoon.

With the help of its patent position, Myriad has maintained a monopoly on the commercial BRCA testing market for two decades. BRACAnalysis costs around $4,000. Before taking legal action against Ambry, the company has said that it would compete with other labs providing BRCA testing on turnaround time, the quality of its test, and customer service.

The company said in its complaint filed with the court that it has invested more than $500 million since the early 1990s to develop and continue to improve the BRACAnalysis test. The test accounts for more than 80 percent of the company's product revenues.

In AMP v. Myriad, healthcare providers, researchers, and patients challenging Myriad's patents had alleged that the company was exercising its patents to thwart patient access to affordable testing and to hinder research. Myriad's Rogers asserted that the company has been unfairly represented in this regard during the course of the case, adding that these allegation "couldn't be further from the truth."

In attempt to correct these perceptions, Myriad also issued a pledge to patients, promising to not impede non-commercial, academic research that uses its patented technology; not interfere with labs conducting genetic testing to provide a second opinion result or confirm test results provided by Myriad; and to continue to provide financial assistance and free testing to patients with a financial need.

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