10x Genomics, Inc. (Nasdaq: TXG), a leader in single cell and spatial biology, announced  that the European Unified Patent Court ("UPC") issued a preliminary injunction against NanoString Technologies, Inc. (Nasdaq: NSTG) for infringing European Patent 4 108 782 B1 ("the EP 782 patent," docket No 459746/2023). The preliminary injunction, issued by a panel of four judges with both legal and technical expertise, prevents NanoString from selling or providing services using its CosMx Spatial Molecular Imager (SMI) instruments and CosMx reagents for RNA detection in all 17 countries of the UPC.

Eric S. Whitaker, Chief Legal Officer for 10x Genomics, said: "Since the formation of 10x, our unwavering commitment has been to drive innovation to push science forward. We have made massive investments in cutting edge research and development resulting in revolutionary products transforming the world's understanding of health and disease. The entire purpose of patent systems around the world is to protect such innovations and encourage such investments. We will be steadfast in protecting the inventions that scientists have worked so hard to create, as innovation is what fuels and funds the development of future 10x technologies that benefit researchers – and ultimately patients."

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.

10x Genomics' acquisitions of ReadCoor and Cartana in 2020 accelerated its technology development of the Xenium in situ platform and provided 10x with access to key inventions, including what became the EP 782 patent, from the earliest pioneers of in situ analysis. This patent relates to the initial discoveries of critical and foundational technical features for in situ analysis, which underpin 10x's Xenium platform, a high performance system combining state-of-the-art instrumentation, curated and customizable gene panels and robust software to deliver best-in-class sensitivity, specificity and throughput.

"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."

The ruling of the UPC is subject to appeal. The preliminary injunction takes immediate effect today.  The full opinions of the Unified Patent Court will be posted here when available: 10xgen.com/munich-spatial-news.

Related Litigation

In a separate case before the UPC, 10x also requested a preliminary injunction against the CosMx Spatial Molecular Imager (SMI) instruments and CosMx reagents for RNA detection for infringing European Patent 2 794 928 B1 ("the EP 928 patent," docket No 459996/2023), which is in effect in France and the Netherlands in addition to Germany. The UPC held a hearing on this request today and announced that it expected to issue a decision on October 10, 2023. 

In the United States, 10x filed suit against NanoString in the U.S. District Court for the District of Delaware alleging that NanoString's GeoMx Digital Spatial Profiler and associated instruments, reagents and services infringe: (a) U.S. Patent No. 10,472,669; (b) U.S. Patent No. 10,961,566; (c) U.S. Patent No. 10,983,113; (d) U.S. Patent No. 10,996,219; (e) U.S. Patent No. 11,001,878; (f) U.S. Patent No. 11,008,607 and (g) U.S. Patent No. 11,293,917. Trial is scheduled for November 2023.  On September 7, the Court issued summary judgment in favor of 10x and dismissed NanoString's defenses relating to  invalidity for indefiniteness. 10x has stated that it intends to seek more than $30 million in damages for sales prior to trial; this amount can be trebled in the event that the jury finds NanoString's infringement willful. 10x also intends to seek an injunction against sales of GeoMx as well as ongoing damages.

10x filed a second suit against NanoString in the U.S. District Court for the District of Delaware alleging that NanoString's CosMx Spatial Molecular Imager and associated instruments, reagents and services infringe multiple patents in the same patent family as EP 782 and EP 928, the patents NanoString has been enjoined from infringing by the UPC and German courts. The patents asserted in the second U.S. suit against NanoString include (a) U.S. Patent No. 10,227,639; (b) U.S. Patent No. 11,021,737; (c) U.S. Patent No. 11,293,051; (d) U.S. Patent No. 11,293,052; (e) U.S. Patent No. 11,293,054 and (f) U.S. Patent No. 11,542,554.  Trial is scheduled for September 2024.

As previously announced, in February 2023, a five judge panel from the German Federal Patent Court, which included technical experts, issued a preliminary opinion finding the asserted claims of the EP 928 patent valid (docket no. 3 Ni 20/22). An oral hearing is scheduled for May 7, 2024.  On May 17, a three judge panel of the Munich Regional Court found that the EP 928 patent was infringed and issued an injunction that requires NanoString to stop selling and supplying CosMx SMI instruments as well as CosMx reagents for RNA detection in Germany (docket No. 7 O 2693/22). NanoString appealed this decision to the Higher Regional Court Munich (docket No. 6 U 2360/23 e). A decision is not expected before late 2024.

Prior to today's preliminary injunction ruling on the EP 782 patent, 10x filed two main actions before the UPC to obtain decisions on the merits regarding infringement of the EP 782 and EP 928 patents by NanoString selling or providing services using its CosMx Spatial Molecular Imager (SMI) instruments and CosMx reagents for RNA detection. Decisions on both main actions are expected for late 2024 (docket No 568963/2023 re EP 782; docket No 573637/2023 re EP 928).