Natera, Inc. v. NeoGenomics Laboratories, Inc., Appeal Nos. 2024-1324, -1409 (Fed. Cir. July 12, 2024)

In its only precedential patent opinion last week, the Federal Circuit affirmed a preliminary injunction that largely prohibits the use, manufacture, or sale of NeoGenomics’ “RaDaR” assay for cancer remission, and agreed that Natera had shown a likelihood of success on its claim that RaDaR had infringed its U.S. Patent No. 11,519,035. In its opinion, the Court discussed considerations relating to Natera’s likelihood of success, irreparable harm, and the public interest. Among other items, the Court provided noteworthy guidance on an accused infringer’s burden to show invalidity at the preliminary injunction stage, as well as how an injunction may be tailored to avoid public harm when it prohibits the use or sale of healthcare products.

The ’035 patent claims particular methods of treating DNA samples to determine the prevalence of circulating tumor DNA, which is a kind of cell-free DNA (“cfDNA”) shed into the bloodstream by tumor cells. In arguing that the claims were invalid, NeoGenomics had argued that at the time of the invention, cfDNA was well known for its uses in cancer analysis, as were certain of the general DNA amplification techniques employed in the claimed methods. Although a defendant’s burden at the preliminary injunction stage is only to show a “substantial question” of invalidity, the Federal Circuit affirmed that NeoGenomics’ showing had fallen short. Specifically, the Court agreed that NeoGenomics’ conclusory, four-paragraph obviousness argument was overcome by Natera’s substantial evidence of the known difficulties of employing traditional sequencing and amplification techniques with cfDNA, such that a skilled artisan would not have a reasonable expectation of success in combining elements of the prior art, as NeoGenomics suggested. The Federal Circuit rejected NeoGenomics’ assertion that “mere vulnerability” to an invalidity challenge was sufficient to avoid a preliminary injunction, and found that because it had not established a motivation to combine, NeoGenomics had not raised a substantial question of invalidity.

On the question of the public interest, the district court’s injunction order  discussed exceptions for certain ongoing and imminent uses of the RaDaR assay, such as for patients who already use RaDaR; for finalized or in-process research and studies; and even for future research to be undertaken pursuant to contracts that were already in negotiation. The Federal Circuit commended the district court for tailoring its order to minimize the risk of harm to patients and to third parties such as NeoGenomics’ research partners, and otherwise rejected NeoGenomics’ arguments that Natera’s competing remission assay could not meet patients’ needs. NeoGenomics had argued that RaDaR was “irreplaceable” for its allegedly superior sensitivity and the range of cancers it could detect, but the district court had found that much of the plaintiff’s evidence was conclusory and/or rebutted by contrary evidence from Natera. The Federal Circuit found that the lower court had not abused its discretion in weighing the conflicting evidence and finding that Natera’s competing assay could satisfy patient needs in those instances not already carved out from the injunction.

The Federal Circuit also rejected NeoGenomics’ argument that Natera had not shown a causal nexus between the ’035 patent’s claims and its alleged irreparable harm. Though it was undisputed that sales of both parties’ competing assays were driven by their ability to factor in a cancer’s specific DNA to assess remission risks (referred to as “tumor-informed” testing), NeoGenomics argued that because the ’035 patent claimed only certain sequencing and amplification methods, and not tumor-informed testing itself, the district court had erred in finding irreparable harm “by tying the alleged harm to an unclaimed feature.” However, the district court had also been presented with evidence that such tumor-informed testing would be impossible to achieve without the claimed methods, and the Federal Circuit agreed that Natera had shown a sufficient nexus to establish irreparable harm.

The Court considered and rejected other arguments raised by NeoGenomics, and ultimately affirmed the preliminary injunction.

The opinion can be found here.

By Jason A. Wrubleski

This article summarizes aspects of the law and does not constitute legal advice. For legal advice for your situation, you should contact an attorney.