Natera, Inc. v. NeoGenomics Lab'ys, Inc. United States Court of Appeals of the Federal Circuit, 2024 106 F.4th 1369

Natera owns two relevant patents claiming methods for amplifying targeted genetic material and for detecting variations in genetic material indicative of disease or dis-ease recurrence. Natera uses the claimed methods in in its Signatera product, a "tumor-informed" molecular residual disease (MRD test). NeoGenomics offers a competing product under the brand name RaDaR. Natera sued NeoGenomics alleging RaDaR infringed the patents and moved for a preliminary injunction, which the district court granted. The preliminary injunction bars NeoGenomics from making, using, advertising, or distributing its RaDaR assay, but carves out exceptions for patients already using RaDaR and for finalized or in-process research projects, studies, and clinical trials. NeoGenomics appealed the preliminary injunction, and the Federal Circuit affirmed, concluding that NeoGenomics had not shown that the district court had clearly erred. In assessing the likelihood that Natera would suffer irreparable harm if the injunction were not granted, the district court had taken into account the fact that the two companies are direct competitors in a two-player market for tumor-informed MRD testing products, along with Natera's unwillingness to license its patent and the potential for lost biopharmaceutical partnerships, business relationships, clinical opportunities, and market share. The evidence showed that patients using MRD therapies require continuity of care, making it impractical to transition to a different diagnostic test, which supported a finding of irreparable harm because patients who begin using RaDaR now will likely not switch to Signatera in the future. In concluding that the public interest weighs in favor of the preliminary injunction, the court concluded that, because Signatera is clinically validated for use with the same cancers as RaDaR, any patients in need of a tumor-informed MRD test will be able to access one through Natera. The district court also found Natera has the capacity to take on more customers to satisfy increased demand for MRD tests. While NeoGenomics emphasized the importance of "patient choice," the Federal Circuit responded that "[t]aken to its logical extent, NeoGenomics' argument would preclude a preliminary injunction for any medical or healthcare-related product because such an injunction would narrow the field of products available to patients."