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10x Genomics and Harvard University have sued Element Biosciences, alleging that Element’s AVITI24 multiomics platform, Teton chemistry, and related services infringe on four university-owned patents exclusively licensed by the genomics and sequencing tools giant—while Element has denied wrongdoing and promises to fight the lawsuit.

At issue are four patents—three of which cover technologies related to methods of analyzing the nucleic acids of a cell, awarded between 2021 and 2023, and all titled, “Compositions and methods for analyte detection”: U.S. Patent Nos. 11,021,737 (‘737), 11,566,276 (‘276), 11,566,277 (‘277).

The fourth patent in question, U.S. Patent No. 12,264,358 (‘358), covers methods of selectively sequencing amplicons in a biological sample, and was awarded in April 2025 under the title, “Method of selectively sequencing amplicons in a biological sample.”

“Element’s employees, customers, collaborators, and partners have practiced and continue to practice (with Element’s knowledge) one or more claims of the Harvard patents by using the AVITI24 platform and Teton workflow,” 10x and Harvard alleged in a court complaint filed May 7 in U.S. District Court for the District of Delaware. “Through the development and subsequent making, using, selling, offering for sale, and/or importing of the Accused Instrumentalities, Element has and continues to infringe the Harvard Patents.”

At the deadline, the case, 1:26-cv-00538-UNA, had not been assigned to a U.S. District Judge.

10x and Harvard have asked the court to find that Element infringed the four patents in question, declare that Element’s infringement “has been willful and deliberate;” declare each Harvard-owned patent to be “valid and enforceable;” issue a permanent injunction barring Element from using technologies based on the patents—otherwise pay 10x and Harvard “an award of post-judgment royalty to compensate for future infringement;” as well as require Element to pay 10x’s and Harvard’s attorneys’ fees and “such other and further relief as the Court may deem just, reasonable, and proper.”

Element responds

Element responded to the complaint a day later with a statement denying wrongdoing and promising to fight the lawsuit.

“Element strongly disagrees with the allegations made by 10x Genomics and believes the claims are without merit,” the firm stated. “Element will vigorously defend its technology and remains focused on delivering differentiated solutions that expand scientific discovery and customer choice. Element was founded to expand innovation and competition in the life sciences industry. We remain confident in our technology, our intellectual property, and the differentiated value our products provide to customers,” the company added. “We will continue to focus on supporting our customers and advancing the next generation of scientific innovation.”

AVITI24, launched in 2024 as a top-tier successor to its AVITI benchtop DNA sequencer and introduced two years earlier as a next-gen sequencing (NGS) platform, aims to enable simultaneous analysis of multiple biological signals—DNA, RNA, proteins, phosphoproteins, and cell structure within single cells—through a 5D multiomics system designed to deliver both spatial, single cell multiomics as well as high-quality, affordable sequencing.

Earlier this year, Element announced plans to begin offering Direct In Sample Sequencing to tissue—both FFPE and fresh frozen—during the second half of this year through AVITI24. “By contrast, 10x’s Xenium product included fresh frozen and FFPE tissue capabilities at the time it was introduced in 2022,” 10x countered in the complaint.

Element has applied AVITI24 to offer customers a combined in situ multiomics and next generation sequencing service through its AVITI24 Technology Access Program.

“Element practices the Harvard patents by using the AVITI24 platform on behalf of its own scientists and researchers and for its AVITI24 TAP customers,” 10x and Harvard alleged in their complaint, adding: “Through the AVITI24 TAP, customers submit samples to Element. Element practices the Harvard Patents by analyzing the samples using the Teton workflow on the AVITI24 platform.”

Stifling or protecting?

In its statement, Element also repeated an argument made by several other companies sued by 10x in recent years: “We believe this lawsuit yet again reflects a broader pattern of using the same patent portfolio to stifle innovations across the industry.”

Countered Michael Schnall-Levin, 10x’s chief technology officer, chief strategy officer, and founding scientist: “We strongly disagree with that characterization. 10x welcomes competition and innovation. “Over the past decade, we’ve invested more than $2 billion in R&D that has transformed how biology is studied. Protecting that work is part of our responsibility as innovators and is what enables us to continue investing in the next generation of technologies.”

Element is the latest of 10x’s rivals to find itself the target of a patent infringement lawsuit filed by 10x. Last year, 10x settled separate lawsuits with Vizgen and Bruker—the latter acquiring NanoString in 2024 from U.S. Bankruptcy Court after the company sought protection from creditors under Chapter 11 of the U.S. Bankruptcy Code, blaming a $31 million jury award assessed against it in 2023 in a patent infringement case filed by 10x.

In October, 10x joined with two licensor partners, Prognosys Biosciences and Roche Sequencing Solutions, to file a pair of federal lawsuits accusing sequencing and multiomics giant Illumina of infringing on nine patents related to spatial biology and single-cell sequencing. Earlier last year, Illumina sued Element, accusing its smaller rival of infringing on five of its patents covering flow cell and imaging technologies used in automated genetic sequencing.

Schnall-Levin said 10x’s latest wave of litigation, starting last year, was not a response to competitive pressures the company has discussed publicly, such as academic customers slowing down spending due to federal budget cuts: “Our litigation is driven by the merits of each case based on clear evidence of others infringing our patents.”

“We consistently act when others infringe our single cell and spatial patents,” Schnall-Levin added.

Speaking with GEN last year, Serge Saxonov, PhD, co-founder and CEO of 10x Genomics, defended the company’s approach to protecting its intellectual property: “If others end up infringing and copying our inventions, then we have to protect them. It is incumbent on us, both as a means of serving our mission and as a means of being fair to all our stakeholders.”

Patents detailed

In their lawsuit, 10x and Harvard allege that the ‘358 amplicon sequencing patent’s claims cover “concrete, unconventional” methods for sequencing RNA molecules in cell or tissue samples by generating circularized RNA molecules by crosslinking or copolymerizing circular DNA, amplifying the circular DNA to produce amplicons, then using selective sequencing primers to sequence different subsets of the amplicons at a time: “These additional unconventional combinations include sequencing by synthesis (Claim 15) and using at least sixteen different selective sequencing primers (Claim 18).”

The other three patents, which cover analyte detection, include claims directed to “concrete, unconventional methods that cover:

• ‘276: multiplex detection of analytes in biological samples by contacting the biological sample with ‘detection reagents.’
• ‘277: multiplex detection of analytes in cell and tissue samples by binding ‘detection reagents’ to the cell or tissue sample.
• ‘737: Multiplex detection of analytes in cell and tissue samples by contacting the cell or tissue sample with ‘detection reagents.’”

10x says the methods of all three patents are practiced by its two spatial biology platforms—the Xenium In Situ single-cell spatial imaging platform, launched in December 2022, and the Atera spatial platform, unveiled last month during the American Association for Cancer Research (AACR) conference.

Atera, which is designed to enable whole-transcriptome spatial biology at scale, offers more plex, throughput, and sensitivity than Xenium, thus enabling whole-transcriptome at scale. Atera includes an all-in-one instrument for sample imaging, liquid handling, hardware stabilization, and onboard analysis.

According to 10x, Atera enables 800 whole transcriptome samples per year, a 500 mm² imageable area per slide, and four slides per instrument run. Users can choose from Atera WTA, which allows for analysis of 18,000 genes, or Atera Select 1,000 custom gene panels with optional stacking of up to two 1,000-gene panels. Compared to Xenium, Atera has four times the throughput, six times higher plex capacity for targeted assays, 3.6x higher plex, and 2–3x sensitivity for whole transcriptome assays.

10x has said it plans to make Atera available in the second half of this year, though it has begun taking orders for the Atera, which is list-priced at $495,000 and measures roughly 53” x 36” x 64” or (4.42 ft × 3 ft × 5.33 ft).

Acquired for $350M

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

Church and Je Hyuk Lee, MD, PhD, founder of Terrain Life Science and an investigator who developed Fluorescent In Situ Sequencing while a research fellow in Church’s lab more than a decade ago, are listed as first and second investors on all four patents.

The analyte detection patents (‘737, ‘276, and ‘277) also list two other Church lab alumni: Daniel Levner, PhD, co-founder and CTO of Emulate; and Michael Super, PhD, senior director, translational R&D with the Hansjörg Wyss Institute for Biologically Inspired Engineering at Harvard University, as co-inventors.

The amplicon sequencing patent (‘358) lists as co-inventors two other Church lab alumni: Richard C. Terry, who became ReadCoor’s CEO before his current post as CEO, CTO, and founder of cell therapy manufacturer Harton, and Evan R. Daugharthy, PhD, Harton’s president, CSO, and founder.

The post 10x Genomics, Harvard Target Element’s Multiomics Platform in Patent Lawsuit appeared first on GEN – Genetic Engineering and Biotechnology News.