Illumina and Sequenom take on Ariosa in DNA patent infringement case

Illumina and Sequenom have filed a patent infringement case against Ariosa Diagnostics for a patent covering DNA testing in pregnant women.

The claim was filed at the US District Court for the Northern District of California San Francisco Division on Tuesday, May 15.

The lawsuit centres on Ariosa’s alleged infringement of Sequenom’s “Non-invasive detection of fetal genetic traits” patents (US numbers 9,580,751 and 9,738,931). The patents relate to an “improved technique for preparing and analysing extracellular circulatory DNA”. Illumina is the exclusive licensee of the patents.

“By combining DNA extraction processes with techniques for size-discrimination and removal, the inventors [Sequenom] created a technique that enabled researchers to enrich samples for foetal DNA, thereby improving the low signal-to-noise ratio that had plagued researchers studying cell-free DNA from pregnant human females,” said the claim.

According to the claim, Ariosa provides a non-invasive prenatal test for the “determination of foetal chromosomal abnormalities”. The alleged infringing product is marketed under the name ‘Harmony Prenatal Test’, which detects abnormalities including Down syndrome.

In 2014, Ariosa was acquired by Roche, which is also being sued by Illumina and Sequenom.

Illumina and Sequenom claimed that the Harmony test infringes several claims from the ‘751 and the ‘931 patents.

The lawsuit alleged that the Harmony test includes a process called ‘Create UNA’ in which “magnetic beads are mixed with cell-free DNA that has been extracted from blood plasma”.

This includes a “size discrimination” process that “prepares a fraction of cell-free DNA consisting of fragments that are less than approximately 300 base pairs in length”.

Illumina and Sequenom are seeking an enjoinment and damages.