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Illumina, Roche Agree to Settle NIPT Patent Lawsuits

NEW YORK – Illumina and Roche have settled several patent lawsuits over sequencing-related methods used in noninvasive prenatal testing.

In two joint filings in the US District Court for the Northern District of California on Wednesday, the parties told Judge Susan Illston that they had "mutually agreed to a settlement" of their respective claims against each other across four cases and asked her to dismiss those lawsuits. They asked the court to dismiss some of the claims with prejudice, meaning they could not be revived, while asking for other claims to be dismissed without prejudice.

It's unclear what the terms of the settlement are. Sequenom, now part of Laboratory Corporation of America, is also a plaintiff in one of the cases. An Illumina spokesperson said the firm does not comment on settlements in legal proceedings. Roche and LabCorp did not immediately respond to requests for comment. But the agreement ends one of the biggest sequencing technology patent battles over the last decade.

Verinata Health, acquired by Illumina in 2013, initially filed suit against Ariosa Diagnostics in 2012. Illumina sued again in 2014 and 2015, alleging infringement of US Patent Nos. 8,318,430 entitled "Methods of Fetal Abnormality Detection" and 7,955,794 entitled "Multiplex Nucleic Acid Reactions." Ariosa countersued for non-infringement and invalidity of the patents, as well as for breach of contract and breach of the covenant of good faith and fair dealing. In June 2018, a jury awarded Illumina $26.7 million in damages for patent infringement stemming from the 2014 lawsuit. Ariosa appealed and in April 2020, the US Court of Appeals for the Federal Circuit affirmed the lower court's decision.

In 2018, Illumina and Sequenom, who had reached a patent pooling agreement in 2014, sued Ariosa alleging infringement of two patents covering the cutoff length for enriching the fraction of fetal DNA in a blood sample from the mother. Sequenom had been awarded a patent for selecting cell-free DNA in such samples of less than 500 bp, and later, 300 bp length.

Ariosa countersued, alleging invalidity of the patent on the grounds that the difference in length between most maternal DNA and most fetal DNA was a natural law, and thus, unpatentable.

Illston agreed with Ariosa and threw out that case in December 2018. However, Illumina appealed that finding, and last year, the US Court of Appeals for the Federal Circuit reversed that decision and sent the case back to the district court. Ariosa appealed the reversal to the US Supreme Court in 2020; however, last week the parties had their petition to have the case heard dismissed and told the district court that they were close to settling the originating cases.

Illumina had asked the court to award it supplemental royalties, a request that it asked to be withdrawn. Whether royalties are part of the settlement agreement is not yet known.

In the case brought by Illumina and Sequenom, the parties asked that Ariosa's counterclaims for non-infringement and invalidity be dismissed without prejudice.

Illumina has also sued Natera and Premaitha Health for infringement of NIPT-related patents.