This article has been updated to clarify that the injunction is part of a settlement and that the name of Neogenomics' upcoming MRD assay has not yet been decided.
NEW YORK – The District Court for the Middle District of North Carolina on Monday issued a permanent injunction against NeoGenomics Labs' RaDaR assay in the US in a patent infringement suit brought against the company by Natera. In addition, the firms have settled their lawsuit, and NeoGenomics said it is working on a new version of its assay that will not infringe Natera's IP.
The order enjoins NeoGenomics from "making, using, selling, or offering for sale in the United States" the RaDaR assay and any assay or other product "not more than colorably different" from the RaDaR assay. Exceptions to this injunction include research and development projects, as well as clinical trials begun before Jan. 10 of this year and instances where patients were using the assay before that date.
The injunction follows a preliminary injunction that the same court granted in December of last year.
While the preliminary injunction stated that Natera had shown enough evidence to likely succeed in proving that the RaDaR assay infringed on its patent No. 11,519,035, the current injunction says that NeoGenomics does not contest having infringed claims related to both that patent and patent No. 11,530,454. Both are method patents relating to amplifying targeted genetic material while reducing amplification of nontargeted material and underpin Natera's Signatera minimal residual disease assay.
In a call with investors last April, NeoGenomics said it had petitioned for inter partes review of the patents by the US Patent and Trademark Office, seeking to determine that they were unpatentable because of prior art. The USTPO later denied that petition.
"NeoGenomics made an informed, strategic decision to settle the ongoing patent infringement lawsuit with Natera," a company spokesperson said via email. "While the terms of the resolution are confidential, the original RaDaR assay will be retired. With this matter resolved, we are now fully focused on advancing our innovative technology, including the development of an updated version of our highly sophisticated MRD assay."
Natera first sued NeoGenomics in the summer of 2023, as an extension of a separate patent infringement lawsuit brought against Inivata in 2021.
In a call with investors early on Tuesday, NeoGenomics CEO Christopher Smith said the injunction only covers the first version of the RaDaR assay, which the company has since updated.
"We are proceeding with design and development stage and CLIA validation, which we are targeting for the first half of 2025," he said. "We believe this new version will be free and clear of IP Natera asserted against the original RaDaR product."
NeoGenomics chief counsel Ali Olivo added that the inter partes review had been denied on administrative, rather than substantive grounds. "We're going to continue to pursue and defend RaDaR from any claims of infringement," he said.