UPC Ruling in Favor of 10x Genomics Leads to Injunction Against NanoString in 17 EU Countries; Spatial Genomics Legal Battle Heating Up With U.S. Trials Pending

NanoString Technologies, Inc., a provider of life science tools for discovery and translational research, has responded to the European Unified Patent Court’s (UPC) preliminary injunction against its CosMx™ Spatial Molecular Imager (SMI) products for RNA detection in the ongoing patent dispute with 10x Genomics and Harvard. The preliminary injunction, which applies immediately in 17 European Union Member States, has led NanoString to announce its intention to appeal this decision in the UPC Court of Appeal in Luxembourg.
NanoString believes that the court failed to sufficiently consider evidence indicating that 10x Genomics’ asserted patents received substantial funding from the National Institutes of Health with a requirement for open and non-exclusive licensing to serve the public interest.
Despite the preliminary injunction, NanoString asserts that its legal ability to market and sell CosMx SMI products for protein detection within the European Union remains unaffected. Furthermore, the company noted the ruling does not impact the lawful sale of any NanoString CosMx SMI products in the United States, the United Kingdom, or other regions outside the EU Member States involved in the UPC system. The company estimates that less than 10% of the CosMx instrument orders in backlog are for EU countries directly affected by the preliminary injunction. The company also reaffirmed its fiscal year 2023 total revenue guidance of $175 million to $185 million. The injunction on the EP 782 patent requires that NanoString stop selling or providing services using the CosMx SMI instruments as well as CosMx reagents for RNA detection in Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Portugal, Slovenia and Sweden.
Following the decision, Eric S. Whitaker, Chief Legal Officer for 10x Genomics, said: “A patent holder must meet a very high standard to win a preliminary injunction,” added Whitaker. “Two separate courts have now found that NanoString’s CosMx products infringe two different 10x patents, and three separate courts have preliminarily found the 10x patents valid in the asserted scope. In total, three courts have analyzed hundreds of pages of arguments made by NanoString and have rejected NanoString’s repeated claims that it does not infringe 10x patents, that the patents are invalid or that NanoString’s claims to a license have merit. Although we welcome legitimate competition on the merits, competition based on our own innovations must stop.”
In June, 2023 10x Genomics, a leader in single-cell and spatial biology, initiated the patent litigation against NanoString Technologies and Vizgen in the European Unified Patent Court (UPC). These lawsuits alleged that NanoString’s CosMx products for RNA detection infringe European Patents 2,794,928 B1 and 4,108,782 B1, while Vizgen’s MERSCOPE products are accused of infringing the EP 782 patent. These patents pertain to in situ detection of analytes.
Furthermore, on May 17, the Munich Regional Court found that the EP 928 patent was infringed and issued an injunction against NanoString in Germany. This injunction required NanoString to cease selling and supplying CosMx SMI instruments and RNA detection reagents in Germany. However, the judgment is subject to appeal. Additionally, in February 2023, the German Federal Patent Court issued a preliminary opinion confirming the validity of the asserted claims of the EP 928 patent.
There is also litigation ongoing between the companies in the United States. In May 2021, a lawsuit was filed by 10x Genomics against NanoString Technologies, Inc. in the U.S. District Court for the District of Delaware. The lawsuit alleges that NanoString’s GeoMx Digital Spatial Profiler, along with associated instruments and reagents, infringe multiple U.S. patents. Subsequent amended complaints were filed in May 2021 and May 2022 to add further patent infringement claims. NanoString responded to the lawsuit in May 2022 and a trial set for November 2023. In February 2022, 10x Genomics filed a second lawsuit against NanoString in the same Delaware court. This lawsuit concerns NanoString’s CosMx Spatial Molecular Imager, its associated instruments, reagents, and services, alleging infringement of specific U.S. patents. An amended complaint was filed in May 2022 to add more patent infringement claims, and NanoString responded in May 2022. Discovery is ongoing, and a trial is set for June 2024. In August 2022, NanoString countersued in the CosMx Action, asserting that 10x Genomics’ Visium products infringe U.S. Patent No. 11,377,689. 10x Genomics responded to the counterclaim in August 2022 and moved to sever claims related to U.S. Patent No. 11,377,689 and consolidate them with a patent case filed by NanoString against 10x Genomics in October 2022.