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Gene by Gene Joins Ambry in Countersuit against Myriad Alleging Antitrust Violations

This article has been updated from a previous version that stated incorrectly that Gene by Gene has performed 1 million BRCA tests globally.

NEW YORK (GenomeWeb News) — Gene By Gene said today it is joining Ambry Genetics in countersuing Myriad Genetics for allegedly violating antitrust laws.

Ambry and Gene by Gene are two diagnostics shops that immediately began offering commercial testing services analyzing BRCA1 and BRCA2 genes for hereditary breast and ovarian risk after the US Supreme Court in June invalidated several of Myriad's patent claims on isolated BRCA1 and BRCA2 gene sequences. The court reasoned that DNA segments separated from the body are products of nature, which cannot be patented under US law.

Alterations in BRCA1 and BRCA2 genes are associated with a heightened risk of familial breast and ovarian cancer, and for nearly two decades Myriad was the only company offering testing for these genes helped by its patent position around such testing.

However, in the same ruling, the Supreme Court upheld a number of Myriad's patent claims on synthetic DNA, or cDNA used as probes and primers in diagnostic testing, and generally expressed support for patenting novel applications of the associations between genes and diseases. As such, Myriad believes it still has a strong patent suite, and claims that it holds 500 valid claims in 24 patents underlying its BRACAnalysis test.

Myriad sued Ambry and Gene by Gene in July claiming that by performing commercial BRCA testing, the companies were infringing patents held by it and several other organizations. Earlier this month Ambry responded to Myriad's lawsuit by filing a complaint of its own with the federal district court in Utah, alleging that Myriad is attempting to wrongfully maintain its longstanding dominance in the BRCA genetic testing market by continuing to enforce patents that are invalid; by keeping a secret database of gene-disease information; and by spreading misinformation about competitors’ tests.

Ambry and Gene by Gene believe that the Supreme Court's decision against Myriad's patent claims on isolated gene sequences has opened up the opportunity for other labs to offer BRCA testing.

"The Supreme Court was very clear that gene sequences, even when isolated, cannot be patented," Gene By Gene President Bennett Greenspan said in a statement.

Furthermore, another Supreme Court case, Mayo v. Prometheus has raised the bar for patents around diagnostic methods, and as such, many legal experts have opined that that case may negatively impact some of Myriad's method patent claims around BRACAnalysis.

In response to Myriad's lawsuit, Gene by Gene filed a declaration on Wednesday with the federal district court in Utah laying out the details of its BRCA1/2 test. Gene by Gene offers a Sanger sequencing-based BRCA1 and 2 test, while Ambry offers a number of hereditary cancer panels that include BRCA1/2 and use Illumina's next-generation sequencing platforms.

Outside the US, where it is more challenging to enforce patents around diagnostic testing, Gene By Gene has been providing BRCA testing since 2012.

Myriad is asking the Utah court to issue a preliminary injunction to stop Ambry and Gene by Gene from performing BRCA testing. The court is slated to hold a hearing in these cases in September. In the meantime, Gene by Gene said it will continue to offer BRCA testing to the public.

When Ambry countersued, Myriad responded that the antitrust allegations are baseless. Myriad recently reported fiscal year fourth quarter earnings, which showed that BRACAnalysis accounted for nearly three quarters of the company's revenues.

Myriad reported $174 million in revenues for its fourth quarter, and the BRACAnalysis and BRACAnalysis Large Rearrangement Test brought in $129.6 million and $18.8 million in revenue, respectively. BRACAnalysis revenues increased by 19 percent and BART revenues grew by 310 percent over the comparable quarter.

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