Context: Founded in 2017, notably by three ex-Illumina employees, Matt Kellinger, Mike Previte, and Molly He, San Diego-based Element Biosciences is a startup focused on innovating genetic analysis tools for the research market. In March 2022, the company launched a Next-Generation Sequencing instrument (Element AVITI™ System), which featured contributions from a range of high-profile biotech providers such as Roche and 10x Genomics. Reports show that Element Biosciences has unsurprisingly filed the majority of its patents in the U.S. Patent and Trademark Office (USPTO) (April 26, 2022 InQuartik analysis). However, 45% of its active or pending applications have been found with patentability issues by U.S. patent examiners. More notably, several patents used to reject its applications, including U.S. Patent No. 20210223530 (“Optical system for fluorescence imaging”, now abandoned), belonged to Illumina.
What’s new: Illumina yesterday sued Element Biosciences in the District of Delaware, alleging that it infringed five of its patents related to automated gene sequencing (May 15, 2025 docket).
Direct impact and wider ramifications: Given the size of its share in the bioinformatics sector and its past in active patent enforcement (discussed below), this suit does not come as a big surprise. In gene sequencing technologies alone, Illumina owns an almost 80% market share (June 27, 2024 SanDiegoOmics report). But after being forced to divest GRAIL (which it had initially acquired only three years prior) due to global antitrust enforcement pressure (June 24, 2024 Illumina press release), and the emergence of new entrants Element Biosciences and Singular Genomics, we may see Illumina employ an even more assertive patent strategy in the coming months.
The patents-in-suit generally relate to devices used to conduct DNA sequencing. Four of them are entitled “Systems, methods, and apparatuses to image a sample for biological or chemical analysis”:
- U.S. Patent No. 12,151,241
- U.S. Patent No. 8,951,781
- U.S. Patent No. 11,117,130
- U.S. Patent No. 11,697,116
The fifth patent-in-suit is:
- U.S. Patent No. 12,251,702 (“Flowcell cartridge with floating seal bracket”)
Element Biosciences has already had its gene sequencing-related patents challenged in the U.S. Four of the seven prior art patents used in making novelty rejections against its applications are held by Illumina, according to analysis firm InQuartik, while the remainder are owned by AGCT GmbH, New Objective Inc., and the University of Maryland, College Park. The Illumina patents used in the rejection applications include:
- U.S. Patent No. 20190276886 (“Generalized stochastic super-resolution sequencing”)
- U.S. Patent No. 20140079923 (“Polymer coatings”)
- U.S. Patent No. 20110220775 (“Systems, methods, and apparatuses for detecting optical signals from a sample”)
- U.S. Patent No. 20090272914 (“Compensator for multiple surface imaging”)
Counsel
Richards, Layton & Finger’s Kelly Farnan is lead counsel for Illumina in this suit. She was part of the team that successfully helped GSK settle the U.S. prong of its global patent litigation with Pfizer last month (April 4, 2025 ip fray article).
Illumina patent infringement litigation history
One of Illumina’s most significant cases was a suit it filed against Ariosa Diagnostics in May 2018 in the Northern District of California. The district court initially ruled the patents-in-suit were invalid, but the Federal Circuit reversed that decision two years later. Notably, it found that a method of preparing DNA before testing is patentable, even though that method relies on a naturally occurring phenomenon – a positive development for patentees in the diagnostic space. The company also obtained a huge win in that case in the High Court of Justice for England & Wales (EWHC) in 2019, when the court found Ariosa had infringed one of Illumina’s European patents. The companies settled in May 2021.
Illumina has settled most of its major patent infringement disputes, including a case against Oxford Nanopore Technologies over nanopore sequencing technologies in both the Southern District of California and the United States International Trade Commission (August 25, 2016 Genomeweb article). Its case against China’s BGI Genomics, also involving DNA sequencing technologies, resulted in a settlement in 2022 (July 15, 2022 Reuters article), and, in August 2023, Illumina settled a patent infringement suit against Guardant Health that also alleged trade secret misapproriation (August 1, 2023 Guardant Health press release).
The company was also a defendant in a major case by Ravgen, which involved non-invasive prenatal testing patents. The plaintiff filed a suit in the District of Delaware in December 2020, alleging that Illumina’s genetic tests infringed upon two of its patents. Illumina put up a fight for two years before the companies eventually settled (April 17, 2023 Genomeweb article).