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Natera Files Second Patent Infringement Suit Against NeoGenomics Subsidiary Inivata

NEW YORK – Natera on Tuesday filed a lawsuit against NeoGenomics subsidiary Inivata, claiming infringement of a new patent it was issued that same day.

In a complaint filed with the US District Court of Delaware, Natera alleged that Inivata has unlawfully used its patented technology, covered by US Patent No. 11,530,454, to create its Radar assay, a tumor-informed test for detecting and monitoring residual cancer in patient blood samples.

Natera is asking for a jury trial, judgement that Inivata has infringed its patent, an injunction against further infringement, and monetary damages.

Natera launched its liquid biopsy minimal residual disease (MRD) test Signatera in 2017. The technology used for this test involves upfront tumor tissue sequencing followed by the design of patient-specific panels for sequencing cell-free DNA in blood.

According to the company, its ’454 patent, issued by the US Patent and Trademark Office on Dec. 20 and titled "Detecting mutations and ploidy in chromosomal segments," reflects yearslong research and new methods for amplifying and sequencing cell-free DNA.

As described, the patent covers "performing whole-exome sequencing or whole-genome sequencing on a tumor sample of the subject to identify a plurality of tumor-specific SNV mutations," targeted multiplex amplification of 10 to 500 loci from cell-free DNA isolated from a plasma sample, and sequencing the resulting amplicons to detect one or more of the tumor-specific mutations.

Natera argued that the claims of the ’454 patent are not directed to an abstract idea, natural law, or natural phenomenon, but rather to an "innovative method of sample preparation."

According to the company, as of the date of their invention, the claimed techniques would not have been routine or conventional to perform "either individually or in combination." The firm argued that each element of at least one claim of the ’454 patent is "literally present" in Inivata's Radar assay or is "literally practiced by the processes through which [the test] is practiced."

Like Signatera, Inivata's Radar assay employs upfront tumor tissue sequencing to develop patient-specific mutation panels for sequencing in blood in order to detect or monitor residual cancer.

Inivata began providing the test in the US last year, initially only for clinical trials, with plans for a clinical launch in 2022. Based on the company's website, it does not appear that clinicians are yet able to order the test for their patients.

The new lawsuit joins a prior suit filed by Natera against Inivata in January 2021. In that ongoing suit, the company alleged infringement of its US patents No. 10,262,755, titled "Detecting cancer mutations and aneuploidy in chromosomal segments," and No. 10,597,709, titled "Methods for simultaneous amplification of target loci."