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Counsyl Files for Declaratory Judgment That It's Not Infringing Myriad's BRCA Patent Claims

NEW YORK (GenomeWeb News) – Counsyl, a company that provides carrier screening and genetic testing for inherited conditions, has taken the preemptive action of asking a California federal district court to determine that it wouldn't be infringing Myriad Genetics' patent claims on BRCA 1 and BRCA 2 genes if it were to offer testing on those genes.

In a document filed with the District Court for the Northern District of California, Counsyl is seeking declaratory judgment that "Myriad has no rights against Counsyl" with regards to claims in eight patents, held by Myriad. The company argues that several claims in these patents have already been invalidated by the US Supreme Court and by the US Court of Appeals for the Federal Circuit, giving Counsyl the right to test for BRCA gene alterations associated with the hereditary risk of breast and ovarian cancer.

The patents at issue are patent numbers 5,709,999; 5,747,282; 5,753,441; 6,951,721; 7,250,497; 5,837,492; 6,033,857; 6,05I,379, which underlie Myriad's BRACAnalysis test.

"Our mission at Counsyl is to give millions of men and women affordable access to vitally important information that affects their family and personal health, so they can make informed choices," Ramji Srinivasan, cofounder and CEO of Counsyl, told GenomeWeb Daily News in a statement. "With our advancements in technology and automation, we can ensure that everyone has affordable access to BRCA1 and BRCA2 testing." The company is not making further comments on this lawsuit at this time, a company spokesperson said.

Counsyl's preemptive action against Myriad comes a few months after Myriad sued two genetic testing companies, Ambry Genetics and Gene by Gene, for offering BRCA genetic testing following the Supreme Court's decision in Association for Molecular Pathology et al. v Myriad.

"Myriad's conduct, including Myriad's litigation history, puts at risk Counsyl's legal rights and ability to market its genetic tests and related services related to sequencing and analysis of BRCA 1 and BRCA 2 genes," Counsyl wrote in the complaint. "Accordingly, Counsyl seeks and is lawfully entitled to a declaratory judgment that at least one of the following claims is invalid and/or not infringed."

In AMP v. Myriad, the Supreme Court invalidated a number of Myriad's patent claims on isolated gene sequences underlying its flagship BRACAnalysis test for hereditary breast and ovarian cancer susceptibility. However, the court upheld the company's patent claims on synthetic DNA, or cDNA, which is used in diagnostics methods.

The decision was interpreted by some diagnostics players as opening up the BRCA testing market to competitors. Ambry and Gene by Gene were the first companies to launch BRCA testing after the Supreme Court ruling.

However, Myriad has enforced its patents for nearly two decades to maintain a monopoly in this space, and the company believes the Supreme Court's two-part ruling still allows it to maintain a strong patent position around BRACAnalysis. The test accounts for more than 80 percent of Myriad's revenues. As such, the company sued Ambry and Gene by Gene to protect its business, and likely to establish a leadership position in the next-generation sequencing market. Myriad launched its next-generation sequencing based hereditary cancer test to early-access customers earlier this month.

However, in response to Myriad's legal action, Ambry and Gene by Gene countersued Myriad alleging antitrust violations.

According to the complaint filed by these two companies with the US District Court for the District of Utah, Myriad is attempting to wrongfully maintain its nearly two-decade 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. As a result of these practices, Ambry believes patients are being forced to pay more for BRCA testing available through a single laboratory, Myriad, than if such testing were available from multiple providers.

The Utah federal district court held a hearing with regard to Myriad's case against Ambry and Gene by Gene on Sept. 11. The court has not yet issued a ruling.

"Myriad has stated that it still intends to aggressively and vigorously enforce the '999, '282, '44I, '721, '497, '492, '857, and '379 patents against any entity that makes, uses, sells, or offers to sell genetic tests and related services using the BRCA 1 and/or BRCA 2 genes, such as the sequencing and analysis of BRCA 1 and/or BRCA 2 genes," Counsyl wrote in its complaint.

Counsyl told GWDN that it is not offering BRCA testing services at this time.

The company noted in its complaint that it has "made a substantial research and development investment in improving genetic tests and providing more access at lower cost to related services connected with sequencing and analysis of BRCAI and BRCA2 genes."