Natera files patent lawsuit over DNA technology

The lawsuit alleged the unlawful use of cfDNA technology in RaDaR assay and related products | Adds to an existing legal action the company filed against Inivata.

Natera has filed a complaint against NeoGenomics, alleging patent infringement for unlawfully using its revolutionary cell-free DNA (cfDNA) technology.

Natera accused NeoGenomics of using its cfDNA innovation specifically in connection with the RaDaR Minimum Residual Disease Assay and other related products or assays, in a complaint filed at the US Middle District of North Carolina.

The genetics and bioinformatics company patents relate to detecting and monitoring cancer through non-invasive, blood-based tests using cfDNA technology.

Natera launched its cfDNA test to detect and monitor cancer, called Signatera, said the lawsuit.

The company describes Signatera as a “personalised ctDNA surveillance tool that detects molecular residual disease (MRD) when assessing disease recurrence or treatment response in solid tumours.”

Signatera is designed to screen for multiple tumour-derived targets with each assay.

Background

The lawsuit revolves around two patents owned by Natera: the '454 patent and the '035 patent.

The '454 patent covers “methods for preparing plasma samples to detect ploidy of chromosome segments and single nucleotide variant mutations”, said the lawsuit.

The '035 patent involves “methods for amplifying and sequencing multiple nucleic acid regions of interest in one reaction volume.”

Natera claims that NeoGenomics “designs, develops, makes and uses, or directs or controls the design, development, make and use of, the RaDaR assay by purposefully directing the activities at its CAP/CLIA-certified laboratory in the Research Triangle Park”.

“According to the CAP and CLIA certificates this laboratory is registered to Inivata, a corporate affiliate of NeoGenomics,” said the suit.

Natera accused NeoGenomics of infringing “more than one claim of the ’454 patent and [infringing] more than one claim of the ’035 patent.”

“This lawsuit builds on Natera’s current patent infringement lawsuit in the US District Court for the District of Delaware related to RaDaR tests sold by Inivata, an affiliate of NeoGenomics,” said the company in a  press release.

The complaint states: “NeoGenomics induces Inivata to perform any RaDaR tests that NeoGenomics is not performing itself. While RaDaR is ordered through NeoGenomics Laboratories, its insurance reimbursement certifications and approvals, including MolDX, list Inivata as authorised to perform RaDaR tests.”

Natera alleged that NeoGenomics knowingly infringed on Natera's IP.

“NeoGenomics has actual knowledge of the ’454 patent since at least as early as December 20, 2022, when Natera filed an infringement lawsuit in the District of Delaware asserting the ’454 patent against two corporate affiliates of NeoGenomics: Inivata,” said the complaint.

“NeoGenomics has actual knowledge of the ’035 patent since at least as early as the date of this complaint.”

The lawsuit seeks financial compensation for damages caused by the infringement, attorneys' fees, and an injunction to prevent NeoGenomics from further using Natera's patented technology without authorisation.

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