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US District Court Sides With Roche, Ariosa in NIPT Patent Case Filed by Illumina

NEW YORK (GenomeWeb) – A US District Court has thrown out a patent infringement suit brought by Illumina against Ariosa Diagnostics and parent company Roche regarding non-invasive prentatal testing technologies.

Illumina's lawsuit, which was filed with the US District Court for the Northern District of California in May 2018, alleged that Ariosa's Harmony cell-free, DNA-based non-invasive prenatal test infringed two US patents, numbers 9,580,751 and 9,738,931, for which Illumina holds an exclusive license. But Ariosa and Roche countered in a filing in August that certain claims in those patents were invalid and unenforceable because they didn't pertain to patent-eligible subject matter under US law.

On Monday, US District Judge Susan Illston agreed with the defendants and granted summary judgment in their favor.

Citing previous case law and rulings from the US Supreme Court, Judge Illston wrote, "the Court finds that both the '931 and '751 patents are directed towards patent-ineligible concepts, namely naturally occurring phenomena. Both patents claim results from a test of naturally occurring fetal DNA and do not transform the naturally occurring product into something new."

The '751 patent, to which Illumina holds rights under the 2014 amended patent pool agreement with Sequenom, contains claims that specifically focus on procedures to separate fetal and maternal DNA in a blood sample. The '931 patent, also held by Illumina under the pooled patent deal, makes similar claims but specifically claims an invention that separates fetal DNA that is 300 base pairs or smaller, rather than 500 base pairs as specified in the '751 patent.

Illumina argued in its filing that the selection of 300 to 500 base pairs constitutes "human ingenuity and scientific judgment." It also argued that several laboratory steps, including conducting PCR and using chromatography and electrophoresis, do not occur in nature.

But, the district court, citing the US Supreme Court's 2012 decision in Mayo vs. Prometheus, said that claims of the '751 and '931 patents were not inventive. "The independent claims require three phases: extraction, size production, and selective removal. Each of the steps is described as well-known and conventional."

 Judge Illston wrote that Illumina's "evidence does not raise genuine issues of material fact sufficient to defeat summary judgment," citing with Roche and Ariosa.

The US District Court's ruling comes nearly a year after Illumina was awarded $26.7 million in damages by the same court in a patent suit it filed against Roche and Ariosa for infringement of two other patents covering non-invasive prenatal testing.