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Athena Diagnostics Sues Ambry Genetics over Diabetes Dx Tests

NEW YORK (GenomeWeb News) – Athena Diagnostics has sued Ambry Genetics for allegedly infringing four patents related to genetic tests for certain types of diabetes, according to court documents filed this week.

Athena, a Worcester, Mass.-based specialty brand of Thermo Fisher, filed four separate suits, with each suit claiming that Ambry infringes upon a different patent by selling genetic tests for maturity onset diabetes of the young, neonatal diabetes mellitus, and congenital hyperinsulinism.

According to the complaints, filed in the US District Court for the District of Massachusetts, the intellectual property for the tests was developed at three US research institutions and licensed or acquired by Correlagen Diagnostics.

The IP includes US Patent Nos. 5,541,060 and 6,187,533, both owned by the University of Chicago and covering genetic tests targeting a glucokinase gene and variations of the HNF and TCF genes; US Patent No. 6,054,313, assigned to Baylor College of Medicine and covering tests based on the ABCC8 gene; and US Patent No. 6,274,310, assigned to Massachusetts General Hospital and covering tests based on the IPF1 gene.

Athena said that it signed a development and licensing agreement with Correlagen in 2003 under which Correlagen developed clinical tests based on the patents and provided Athena with an exclusive license to those tests. Athena claims it has been offering and performing the tests in the US.

The agreement also granted Athena the right to sue third parties for infringing Athena's exclusive patent rights for the tests.

According to the various complaints, Ambry, based in Aliso Viejo, Calif., "has performed, and is continuing to perform" tests for diagnosing the various forms of diabetes based on the genes covered in the patents, and has "thereby infringed, and is continuing to infringe [the patents] and Athena's exclusive rights thereunder."

Athena seeks judgment from the court that Ambry has willfully infringed the patents and that it is enjoined from further infringing the patents. Athena is also seeking triple damages for willful infringement, and all other costs and legal fees associated with the lawsuits.

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