Skip to main content
Premium Trial:

Request an Annual Quote

Illumina Wins NIPT Infringement Suit Against Roche's Ariosa Diagnostics

NEW YORK (GenomeWeb) – Illumina announced after the close of the market on Monday that a UK court has ruled that Ariosa Diagnostics infringed its patent covering a method for noninvasive prenatal testing.

The UK High Court of Justice, Chancery Division, Patents Court issued a judgment finding that Ariosa's Harmony cell-free, DNA-based NIPT infringes Illumina's European patent 1 524 321. The court also found the patent's claims were valid.

"We are pleased that the UK Court has again ruled in our favor, continuing to affirm the value of our NIPT portfolio and the significant contributions of the inventors in this field," Illumina General Counsel and Senior VP Charles Dadswell said in a statement.

Ariosa was acquired by Roche in late 2014. In a statement, Elizabeth Baxter, senior director of corporate communications for Roche Sequencing Solutions said that "Roche does not comment on ongoing litigation."   

The win is the latest victory for Illumina's NIPT patents outside the US. In 2017, the same UK court found that Ariosa and its licensee, TDL Genetics, had infringed five NIPT patents licensed by Illumina.

In December 2018 the US District Court for the Northern District of California threw out a patent infringement lawsuit filed by Illumina against Ariosa, invalidating the two US patents at issue. Earlier, in January 2018, the same court awarded Illumina $26.7 million in damages for a different patent infringement suit against Ariosa.

The Illumina EU patent claimed "A fraction of a sample of the blood plasma or serum of a pregnant woman in which, as the result of said sample having been submitted to a DNA extraction, followed by a size separation, of the extracellular DNA, the extracellular DNA present therein substantially consists of DNA consisting of 500 base pairs or less."

In his judgement, Mr Justice Richard Arnold wrote that this claim was "not obvious," "not insufficient," and that TDL Genetics had "infringed at least claim 1."

Arnold also wrote that the defendants asked the Court "to make appropriate findings of fact to enable the issue of law to be argued in a higher court if necessary." Namely, they proposed the court find that "maternal blood and its contents are naturally occurring products." However, Arnold declined to make that finding.

Illumina said it intends to seek "all available remedies for the infringement," including damages, injunctive relief, and attorneys' fees.