NanoString Comments on Unified Patent Court Order

By: NanoString Technologies, Inc. via Business Wire

September 19, 2023 at 11:54 AM EDT

NanoString Will Immediately Appeal Preliminary Injunction Temporarily Blocking NanoString’s Ability to Market and Sell CosMx Spatial Molecular Imager Products for RNA Detection within UPC Member Countries in Europe

NanoString Technologies, Inc. (NASDAQ: NSTG), a leading provider of life science tools for discovery and translational research, commented on today’s order from the European Unified Patent Court (UPC) granting a preliminary injunction effective immediately in 17 Member States of the European Union against NanoString’s CosMx™ Spatial Molecular Imager (SMI) products for RNA detection in NanoString’s ongoing patent dispute with 10x Genomics and Harvard:

“We are disappointed with today’s decision by the UPC and will immediately appeal the preliminary injunction in the UPC Court of Appeal in Luxembourg. We are confident in our belief that we do not infringe the asserted patents, and that the patents will ultimately be found to be invalid. We also respectfully believe the court erred by failing to adequately consider evidence demonstrating that the patents asserted by 10x were funded by a grant of over $19 million from the National Institutes of Health that required open and non-exclusive licensing to promote the public interest.

NanoString remains steadfast in our commitment to defend the scientific community’s access to our products and researchers’ scientific freedom to select the platforms that best advance their research. Importantly, today’s ruling does not impact NanoString’s legal ability to market or sell CosMx SMI products for protein detection in the European Union, nor does it impact the lawful selling of any NanoString CosMx SMI products in the United States, the United Kingdom or the rest of the world outside of the EU member states participating in the UPC system.

We believe that 10x Genomics has resorted to the courts and is misusing non-final court rulings as part of its commercial strategy to eliminate competition in the spatial transcriptomics market to the detriment of the public good. NanoString provides the scientific community with highly differentiated spatial biology tools with capabilities for both spatial transcriptomics and spatial proteomics that exceed those of any other spatial analysis systems. We are proud of the role our CosMx SMI products serve in helping the scientific community to better understand the genome and its functions and ultimately drive breakthrough scientific discoveries that produce lifesaving medical benefits for patients around the world.

NanoString is committed to defending a competitive, innovative marketplace. We will immediately appeal the decision to the UPC Court of Appeal in Luxembourg. We look forward to presenting multiple arguments to invalidate the asserted patents and demonstrate our non-infringement of these patents at the full UPC hearings on the merits of our case. We do not yet have a date for those hearings.”

Brad Gray, President and CEO, NanoString Technologies, Inc.

Today’s order relates to European Patent 4108782B1 (the “‘782 Patent”). The UPC announced that it would issue a decision in the preliminary injunction matter related to European Patent 2794928B1 (the “‘928 Patent”) on Tuesday, October 10, 2023.

As of August 31, 2023, NanoString currently estimates that less than 10% of the CosMx instruments orders in backlog are for the EU countries directly impacted by this decision. NanoString management is reiterating its guidance for fiscal year 2023 total revenue of between $175 -$185 million.

About NanoString Technologies, Inc.

NanoString Technologies, a leader in spatial biology, offers an ecosystem of innovative discovery and translational research solutions, empowering our customers to map the universe of biology. The GeoMx® Digital Spatial Profiler is a flexible and consistent solution combining the power of whole tissue imaging with gene expression and protein data for spatial whole transcriptomics and proteomics. The CosMx™ Spatial Molecular Imager is a single-cell imaging platform powered by spatial multiomics enabling researchers to map single cells in their native environments to extract deep biological insights and novel discoveries from one experiment. The AtoMx™ Spatial Informatics Platform is a cloud-based informatics solution with advanced analytics and global collaboration capabilities, enabling powerful spatial biology insights anytime, anywhere. At the foundation of our research tools is our nCounter® Analysis System, which offers a secure way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision. For more information, please visit www.nanostring.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our intention to appeal the decision of the European Unified Patent Court, our expectations regarding litigation and remedies, the expected timing of the ongoing litigation, the ultimate disposition of the pending litigation, the impact of the pending litigation on our business, our operations and business outlook, and our estimated 2023 operating results. Such statements are based on current assumptions that involve risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties, many of which are beyond our control, include that we may not successfully appeal the European Unified Patent Court’s decision, we may be unsuccessful in the litigation; ongoing litigation may be prolonged, and a final disposition may be delayed; market acceptance of our products; adverse conditions in the general domestic and global economic markets; the effects of ongoing litigation on our business; the impact of competition; as well as the other risks set forth in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. NanoString Technologies disclaims any obligation to update these forward-looking statements.

The NanoString logo, NanoString, NanoString Technologies, GeoMx, CosMx, AtoMx and nCounter are trademarks or registered trademarks of NanoString Technologies, Inc., in various jurisdictions.