Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Natera, Inc. v. NeoGenomics Laboratories, Inc. (July 12, 2024), affirming the U.S. District Court for the Middle District of North Carolina’s grant of a preliminary injunction.
Natera, Inc. (“Natera”) and NeoGenomics Laboratories, Inc. (“NeoGenomics”) are manufacturers of products used for early cancer detection. One method of detection analyzes DNA fragments in the body. Natera owns two patents related to this method, U.S. Patent No. 11,519,035 (“the ’035 Patent”) and U.S. Patent No. 11,530,454 (“the ’454 Patent”) (collectively, the Natera Patents”). Natera’s product, Signatera, is covered by the Natera Patents. NeoGenomics offers a competing product, RaDaR. Both Signatera and RaDaR are “tumor-informed” (as opposed to “tumor-naïve”) tests designed from a patient’s genetic information based on a tissue biopsy of the patient’s tumor.
Natera sued NeoGenomics alleging infringement of the Natera Patents. Natera also moved for a preliminary injunction. The district court granted the preliminary injunction, finding that Natera made the requisite showing, including demonstrating likelihood of success on the merits of its ’035 Patent infringment claim. The preliminary injunction enjoined NeoGenomics from making, using, selling, or offering for sale RaDaR, and from promoting, advertising, marketing, servicing, distributing, or supplying RaDaR. It created a carveout for patients already using RaDaR, in-process or finalized research projects, and clinical trials. NeoGenomics appealed, arguing the district court erred in its (1) treatment of claim construction, (2) obviousness analysis; (3) irreparable harm analysis; and (4) evaluation of the public interest.
The Federal Circuit affirmed. First, the Court determined the district court did not err by evaluating the likelihood of success on infringement before an explicit claim construction. Second, the Court determined the district court did not demand more than is required at the preliminary injunction stage when it rejected NeoGenomics’ obviousness argument, which was supported by only four paragraphs with “no meaningful supporting documentation” or articulated motivation to combine. Third, the Court rejected NeoGenomic’s assertion the district court relied on a categorical rule that irreparable harm exists where the parties are in direct competition. Rather, the district court did not err in relying on Natera’s unwillingness to license the patent, potential lost partnerships, business relationships, and ongoing business, among other factors. Finally, the Court rejected NeoGenomic’s arguments on public interest, which alleged the superior quality of its RaDaR product vis-à-vis Natera’s Signatera product.
Coauthored by Gabrielle Kiefer & Tucker Bender.