KnobbeMedical.com

(December 27, 2023) Natera Inc. succeeded in obtaining a preliminary injunction against NeoGenomics Laboratories, Inc.’s medical assay test. Natera’s ongoing federal lawsuit alleges that NeoGenomics’ product “RaDaR,” a tumor informed molecular residual disease (“MRD”) assay, infringes two of Natera’s patents, U.S. Patent No. 11,519,035, entitled “Methods for Simultaneous Amplification of Target Loci,” and U.S. Patent No. 11,530,454, entitled “Detecting Mutations and Ploidy in Chromosomal Segments.”

The district court granted Natera’s motion for a preliminary injunction, enjoining NeoGenomics from: (a) making, using, selling, or offering for sale the accused RaDaR assay in the United States, and (b) promoting advertising, marketing, servicing, distributing, or supplying the accused RaDaR assay.  However, the court permitted NeoGenomics to continue  making, using, and selling RaDaR for “ongoing treatment, research, and clinical studies.” Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-CV-629, at 21 (M.D.N.C. Dec. 27, 2023).

Natera’s MRD assay, Signatera, and NeoGenomics’ competing assay, RaDaR, are the only two tumor informed MRD tests on the market. These tests are used for detecting trace amounts of circulating tumor DNA in patients, which can be used for early detection of cancer relapse. While tumor naïve MRD tests are available, the court found that tumor informed MRD tests are preferred by oncologists, as tumor informed tests are considered more accurate.

The district court found that Natera established that a preliminary injunction was warranted. Natera showed (1) it is likely to succeed on the merits, (2) it is likely to suffer irreparable harm in the absence of preliminary relief, (3) the balance of equities tips in its favor, and (4) an injunction is in the public interest. On the public interest factor, the court noted that the “public interest in enforcing patent rights tips in favor of granting a preliminary injunction,” despite NeoGenomics’ argument that patients benefit from having access to two testing options. Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-CV-629, at 20 (M.D.N.C. Dec. 27, 2023).

Historically, courts have been divided on granting injunctive relief in patent cases related to medical tests and devices. In Cordis Corp. v. Boston Scientific Corp., for example, the District of Delaware noted the “obvious concern of depriving the public of the best and safest medical devices by limiting competition” in denying Cordis’ motion for preliminary injunction. Cordis Corp. v. Boston Scientific Corp., Nos. Civ. A. 03-027-SLR, Civ. A. 03-283-SLR, 2003 WL 22843072, at *2 (D. Del. Nov. 21, 2003). However, evidence showing an inability to ensure an adequate supply of the medical device in question also impacted the court’s decision in that case. Conversely, in Pozen Inc. v. Par Pharmaceutical, Inc., the Eastern District of Texas granted a permanent injunction, noting the public interest in encouraging innovation in the patent system and Pozen’s ability to meet patient demand. Pozen Inc. v. Par Pharm., Inc., 800 F. Supp. 2d 789, 825 (E.D. Tex. 2011).

In Natera, the court considered the availability of Signatera and Natera’s capacity to take on more customers in weighing the public interest factor. The court concluded that “[t]he need to protect consumer choice does not weigh heavily in favor of denying an injunction, in light of other evidence.” Natera, Inc. v. NeoGenomics Laboratories, Inc., No. 1:23-CV-629, at 21 (M.D.N.C. Dec. 27, 2023). Further, the court was able to craft the injunction in a manner to reduce the adverse effects on the public by including an exclusion for the current users of RaDaR.

NeoGenomics has appealed the Order granting the preliminary injunction to the Federal Circuit, which may provide further guidance on applying the public interest factor in future medical-related cases. The District Court’s Order granting the preliminary injunction is available here.