A U.S. District Court judge has granted Vizgen’s motion to expand its antitrust case against rival 10x Genomics and Harvard University, citing new evidence that has surfaced during the case’s discovery phase.

Visiting Judge Matthew F. Kennelly of U.S. District Court for the District of Delaware is allowing Vizgen to amend its response to the lawsuit brought by 10x and Harvard by adding additional allegations that accuse 10x and Harvard of conspiring to monopolize the market by obstructing Vizgen’s ability to compete globally.

Vizgen cited as examples of anticompetitive activities what it called the unlawful bundling of 10x Genomics’ existing Chromium Single Cell Immune Profiling platform, and its Visium Spatial Gene Expression platform franchises with its Xenium In Situ single-cell spatial imaging platform, as well as what Vizgen alleged to be predatory pricing.

Kennelly also sided with Vizgen in granting the company additional time to depose witnesses, after concluding that some of Harvard’s witnesses “knowingly” engaged in deposition misconduct and purposeful delay. He also extended the case schedule, setting a new trial date in early February 2025.

The case is 10x Genomics, Inc., and President and Fellows of Harvard College, Plaintiffs, v. Vizgen, Inc., Defendant (No. 1:22-cv-000595-MFK).

“We are very pleased with the Court’s decision,” Vizgen CEO Terry Lo said in a statement. “Vizgen remains committed to fair competition and innovation in the single-cell spatial genomics landscape. These recent developments represent progress in protecting researchers’ access to our groundbreaking MERSCOPE® and MERFISH technologies, and our fight against monopolistic anticompetitive practices.”

MERSCOPE is designed to enable massively multiplexed, genome-scale nucleic acid imaging with what Vizgen says is high accuracy and unrivaled detection efficiency at subcellular resolution. MERSCOPE is intended to facilitate a wide range of tissue-scale basic research and translational medicine in oncology, immunology, neuroscience, infectious disease, developmental biology, cell therapy, and gene therapy.

Last month at the American Association for Cancer Research (AACR) 2024 Annual Meeting, Vizgen unveiled an expanded single cell spatial transcriptomics offering that included the MERSCOPE® Ultra Platform and MERFISH 2.0 chemistry.

10x vows to fight

10x responded to the latest decision with a statement vowing to fight Vizgen’s latest antitrust allegations. 10x also repeated its accusation that Vizgen has infringed on its patents for its genomic tool platforms, and additionally accused Vizgen of acting to drive up prices for 10x’s genomic tools.

“The new allegations made by Vizgen that challenge how we price and discount our products have no basis in fact or law and are simply another attempt to distract from their infringement of our patented technology,” 10x stated. “Vizgen wants our customers to pay more. We believe lower pricing is good for customers and stand by our pricing—and discounting—policies.”

10x defended its pricing as fulfilling its commitment to customers to ensure as many researchers as possible have access to its single-cell and spatial portfolio.

“We consistently hear from customers who love our premium technologies but can’t afford to pay a premium price. As a direct response to this feedback, we’ve been partnering with customers and reducing price to make our tools more accessible to the scientific community,” 10x asserted. “We will continue to champion innovation and vigorously defend our ability to price our products in a way that’s best for research. We will not stop our efforts to democratize these important technologies and look forward to proving that Vizgen’s claims that our pricing is anti-competitive have no basis in fact or law.”

10x has defended its strategy of aggressively litigating potential infringement of its patents, contending it is protecting innovation rather than squelching it, as asserted by competitors and by leading academic researchers in the spatial biology community, the latter in a commentary published in February in GEN. 10x CEO Serge Saxonov, PhD, and CSO Ben Hindson defended their approach in a letter to customers and partners: “The narrative portraying 10x as impeding scientific progress could not be further from the truth.”

10x is continuing a defense of the litigation strategy that Saxonov articulated last fall on GEN’s “Close to the Edge” video interview series, when he made his case for 10x’s series of patent lawsuits against NanoString and Vizgen.

Second legal victory since march

In granting Vizgen’s motion, the court gave the company its second legal victory in as many months. On March 7, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO) denied a petition by 10x to launch an Inter Partes Review challenging U.S. Patent No. 11,098,303 B2, which Vizgen licenses exclusively from Harvard. Vizgen has asserted that 10x’s Xenium platform infringes certain claims of the ‘303 Patent.

Xenium In Situ was developed by 10x using technology from ReadCoor, a company that 10x acquired in 2020 for $350 million. ReadCoor was founded by George M. Church, PhD, of Harvard Medical School. In 2016, Harvard licensed patents covering the technology exclusively to ReadCoor.

After Vizgen and another 10x rival, NanoString Technologies, launched their own in situ platforms, Harvard and 10x sued the companies in 2022, alleging that the platforms had infringed upon their patents for Xenium. NanoString and Vizgen responded by accusing Harvard and 10x of violating the agreement through which the NIH granted Harvard and Church $20 million to establish the Center for Transcriptional Consequences of Human Genetic Variation (CTCHGV).

Vizgen and NanoString have cited the application of Harvard and Church for the NIH funding, in which they stated: “CTCHGV will pursue open and nonexclusive licensing agreements that encourage innovations to be made widely available to researchers and commercial entities.”

From bankruptcy to Bruker

NanoString’s challenge to 10x suffered a significant setback in November when a District Court jury awarded $31 million to 10x, siding with that company in its argument that NanoString’s GeoMx® Digital Spatial Profiler (DSP) infringed seven patents that 10x held after exclusively licensing them from Prognosys Biosciences. 10x was awarded $25 million in lost profits, and a $6 million royalty.

NanoString, joined by three of its subsidiaries, filed for Chapter 11 bankruptcy protection from creditors in February. The bankruptcy filing set into motion a sale process in which Bruker acquired substantially all of NanoString’s assets for approximately $392.6 million cash, plus assumption of liabilities, after winning a competitive auction. Yesterday, Bruker said it closed its asset acquisition of substantially all of the assets and rights associated with NanoString’s business, including the nCounter®, GeoMx®, CosMx™, and AtoMx™ product lines.

 

Bruker said it expected the NanoString business to be near break-even by 2026 with resumed revenue growth, margin improvements, and transaction “synergies” that include public company costs that were not assumed in the asset deal. Bruker offered a preliminary estimate stating that for the remainder of 2024, the transaction was expected to lower Bruker’s non-GAAP earnings per share by $0.15 to $0.20.

Citing “significant business disruption and uncertainty,” Bruker said it was not yet able to offer investors financial guidance on the NanoString business for this year: “Bruker expects to add this business to Bruker’s guidance by 2025 and beyond.”

Previous articleUnveiling the Potential of Digital Intelligence to Empower Pharmaceutical Companies
Next articleBoy Dosed with Pfizer DMD Gene Therapy Dies a Year after Phase II Trial