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 more than $60 million.
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 can appeal the decision, though the company did not say whether it would. 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 over the next two years, Guggenheim Securities Analyst Subbu Nambi wrote in a July 14 note to investors. She estimated MiSeq revenue in Germany over the time period to be around $60 million to $70 million. The loss of revenue going forward could be in the “high single-digit [millions of dollars] for 2026 … and approximately $20 million to $25 million for 2027, based on our estimates for MiSeq today,” she wrote.
“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.”
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.