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Illumina Sues Natera Over NIPT Library Prep Patent

NEW YORK (GenomeWeb) – Illumina has filed a lawsuit against Natera, alleging that the company's noninvasive prenatal testing infringes its US Patent No. 9,493,831, which covers methods for library preparation.

Natera began selling its commercial noninvasive prenatal test Panorama in 2013, which relies on analysis of cell-free DNA present in maternal blood using a multiplex targeted PCR approach.

In its lawsuit filed on March 16 in US District Court, Northern District of California, San Francisco Division, Illumina is claiming that in offering and performing Panorama, Natera infringes "literally or under the doctrine of equivalents" claims 1-3, 6-10, 13-22, and 24 of the ’831 patent.

The company also asserts that Natera has infringed the patent willfully and deliberately, at least since December 2016 when Illumina sent the firm a letter to that end.

In an email, a Natera spokesperson said that the new lawsuit is not a surprise.

"We had anticipated that Illumina might file this suit in response to last week’s announcement of our deal with Qiagen. Based on … our knowledge of Illumina’s patents, we feel comfortable that we will prevail in any patent suit with Illumina should it proceed," the firm wrote.

Natera and Qiagen have signed a 10-year agreement to develop cell-free DNA assays for use on Qiagen's GeneReader next-generation sequencing system, for the purposes of prenatal screening.

Natera said that it plans to continue to rely on Illumina products so far as the costs and services remain competitive for its lab. "Our 10-year supply agreement with Illumina does not expire until 2026, and we do not expect this to disrupt our operations," the company wrote.

The NIPT space has been litigious for several years. This January, for example, Illumina won another patent infringement suit against Roche's Ariosa Diagnostics. That suit concerned two patents originally held by Verinata Health, which Illumina acquired in 2013: US Patent No. 8,318,430 and US Patent No. 7,955,794.