Illumina Prevails Against Ariosa in UK Patent Infringement Case

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Illumina said it has won a decision in a U.K. patent court which sided with the company in ruling that one of its patents was infringed by Roche-owned Ariosa Diagnostics and The Doctors Laboratory (TDL) in the methodology of a non-invasive prenatal test (NIPT).

The High Court of Justice, Chancery Division, Patents Court issued a judgment on Monday finding that Ariosa’s Harmony NIPT infringed upon Illumina’s European Patent (U.K. number 1 524 321) titled, “Non-invasive Detection of Fetal Genetic Traits.” That patent was registered in 2003, and has been exclusively licensed to Illumina from Sequenom.

The court also found the claims of the patent to be not obvious and not insufficient. The patent is directed to the size selection of extracellular DNA in maternal plasma samples. Size selection boosts the fetal fraction, leading to fewer test samples being rejected for low fetal fraction.

Specifically, the court held that TDL infringed upon “at least claim 1,” which covers: “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.”

Illumina has filed patent infringement lawsuits in 2016 and again in 2017 which contended that the use of the Harmony test by licensee TDL—the largest independent provider of clinical laboratory diagnostic services in the U.K.—infringed upon various patents, including 1 524 321, the subject of a 2017 lawsuit.

That year, the U.K. patents court ruled in favor of Illumina by holding that Ariosa and TDL had infringed upon European Patent (UK) 0 994 963, also exclusively licensed by Sequenom to Illumina.

“We are pleased that the U.K. 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,” Charles Dadswell, senior vice president and general counsel at Illumina, said in a statement.

Illumina stated that it “intends to seek all available remedies for the infringement, including damages, injunctive relief, and attorney fees.”

Ariosa has acknowledged to the court that it is jointly liable for any infringement by TDL, but has not discussed the case publicly. “Roche does not comment on ongoing litigations,” Elizabeth Schupp Baxter, head of external relations Center of Excellence for Roche Molecular Solutions, told Clinical OMICs today.

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