Economic analysis performed by Dr. Anup Malani and the Secretariat team demonstrates that a preliminary injunction is warranted.

Natera, Inc., which specializes in cell-free DNA testing technology, sought a preliminary injunction against competitor NeoGenomics Laboratories, Inc. (“NeoGenomics”). Revolutionary cell-free DNA detection methods have the potential to detect cancer prior to conventional diagnostic methods, and thereby have the potential to significantly improve patient outcomes. Secretariat* and attorneys at Quinn Emanuel Urquhart & Sullivan presented a comprehensive analysis in support of a preliminary injunction on NeoGenomics’s RaDaR product.

After considering Secretariat’s analysis and the legal arguments of Natera’s attorneys, U.S. District Court Judge Catherine Diane Caldwell Eagles granted Natera a preliminary injunction.  

For a preliminary injunction to be granted, the patent holder must demonstrate that (1) it is likely to succeed on the merits (2) it is likely to suffer irreparable harm in the absence of preliminary injunctive relief, (3) the balance of hardships favors the patent holder, and (4) whether an injunction is in the public interest. Secretariat evaluated factors 2, 3, and 4.  

For irreparable harm (factor 2), Secretariat evaluated harms that Natera would face in the absence of a preliminary injunction and whether those harms were quantifiable and compensable via an award of damages. Secretariat’s analysis involved evaluation of the complex and unique dynamics of the marketplace in which RaDaR and Natera’s Signatera product compete, first-mover advantages, the competitive relationship between the parties, and the nexus between the alleged infringement and the harms faced. Based on the analysis performed, Secretariat determined that Natera would face irreparable harm in the absence of a preliminary injunction and that remedies under the law were insufficient to compensate Natera for the irreparable harm. Judge Eagles agreed, noting that “Natera is substantially likely to suffer irreparable harm from NeoGenomics’s ongoing infringement[.]” 

For the balance of harms (factor 3), Secretariat evaluated the harm Natera would face in the absence of a preliminary injunction relative to the harm NeoGenomics would face if an injunction were granted. Secretariat determined that the balance of harms favored Natera. Judge Eagles agreed, noting that “[t]he harm to Natera if a preliminary injunction is not granted outweighs the harm to NeoGenomics in granting the injunction.” Judge Eagles went on to note that “Signatera has been on the market longer and is predicted to be a major contributor to Natera’s future success. In comparison, RaDaR is relatively new to the market and is not a major product in NeoGenomics’ portfolio. Natera’s projected revenue streams and dependence on Signatera tips the balance of equities in favor of granting the preliminary injunction.” 

For the public interest (factor 4), Secretariat evaluated if a preliminary injunction would harm patients and if there were alternative treatment options available to patients should the injunction be granted. Secretariat determined that protection of intellectual property rights outweighed any potential harm caused by an injunction on RaDaR, in large part because Natera’s competing product, Signatera, could be substituted in place of RaDaR. Judge Eagles agreed, noting that “[t]he public interest in enforcing patent rights tips in favor of granting a preliminary injunction. Anyone in need of a tumor informed MRD test will be able to get one from Natera; Signatera is clinically validated for use with the same cancers as RaDaR.” 

NeoGenomics was allowed to continue using RaDaR in patients already using RaDaR, in support of research and development on projects or studies that began before the entry of the injunction, and in clinical trials in process or already approved by an agency in the United States.  

Dr. Malani was supported by Vice President Dr. Anushree Subramaniam, Managing Director Dr. Matt Farber, Director Kristyn Berretta, Senior Associate Eric Dragon, Senior Associate Isaiah Kline, and Senior Associate Judson Potenza. 

A link to the Order granting the preliminary injunction (subscription may be required) is available here.  

The preliminary injunction in this matter follows a permanent injunction in the Natera v. ArcherDx matter where Secretariat provided comprehensive economic analysis relating to the appropriateness of a permanent injunction. Coverage of the Natera v. ArcherDx matter is available here. 

*Work was performed by team members at Intensity LLC. Intensity is part of Secretariat.