Court Orders Illumina to Halt MiSeq Sales in Germany After Patent Ruling
The Munich-based court ordered a recall and sales injunction on older MiSeq systems in Germany, potentially costing Illumina millions of dollars.
This story has been updated to correct estimates to the financial impact of the court ruling on Illumina.
A German court ruled that Illumina infringed patent rights held by Element Biosciences covering an imaging method used in Illumina’s MiSeq benchtop sequencers.
In a July 14 statement, Element said the Regional Court of Munich found Illumina liable for both direct infringement, through its own use of the patented method in Germany, and indirect infringement, through sales of infringing sequencers and related consumables.
The judgment covers Illumina’s MiSeq and MiSeqDx instruments, as well as any other Illumina imaging system that functions as described in the court’s holding. The court also barred Illumina from selling infringing products in Germany and ordered the company to recall infringing systems and reagents sold since March 31, 2023, refund those customers, and cover the return costs.
Illumina plans to appeal the ruling. In a statement, an Illumina spokesperson called the ruling “narrow and limited in scope,” adding that Illumina has challenged the validity of the patent before the German Federal Patent Court and that the patent expires in January 2028. Moreover, they noted that the ruling applies only to older MiSeq instruments and not the newer MiSeq i100 instruments launched in late 2024.
If it stands, the ruling could cost Illumina as much as $100 million millions over the next two years, Guggenheim Securities Analyst Subbu Nambi wrote in a July 14 note to investors.
“This feels contained today” Nambi wrote, adding that a final decision could take some time. “At this point it does not appear other ILMN systems are impacted.”
“We anticipate minimal impact to revenue, particularly when Illumina launches updated software for the legacy MiSeq,” the Illumina spokesperson said, adding that the company discontinued the legacy MiSeq in September 2025. Illumina declined to say more about how the software update would address the issue of infringement.
Element has also alleged infringement of related patents by Illumina in the US District Court for the District of Delaware, as well as antitrust claims in the the US District Court for the Northern District of California.