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Ravgen NIPT Patents Withstand Illumina Challenge

NEW YORK – Prenatal testing firm Ravgen scored another victory Wednesday in a pair of rulings that uphold its patents on the methods used in noninvasive prenatal testing, fending off a challenge by Illumina.

A panel of administrative judges for the US Patent and Trademark Office's Patent Trial and Appeal Board said Illumina fell short of proving claims that the USPTO had erred in granting Ravgen patents 7,332,277 and 7,727,720, which relate to methods used to identify abnormalities in fetal cell-free DNA in a maternal blood sample by using an agent to inhibit maternal blood cell lysis and identifying ratios of alleles at sites that indicate the presence of abnormalities. Ravgen sued Illumina in December 2020 on allegations of patent infringement, and in July 2021 Illumina filed with the PTAB petitions for inter partes reviews of each of those patents.

Ravgen's lawsuit is ongoing although it was stayed in March 2022 pending the outcome of the inter partes reviews. Illumina had said in filings before the PTAB that the methods described in Ravgen's methods should be considered unpatentable because they are obvious and anticipated through prior research results and commonly understood techniques.

Since June 2020, Ravgen has sued eight diagnostic companies on allegations of patent infringement, securing a series of wins and settlements in federal courts and PTAB proceedings. The firm won a $273 million verdict in September against Laboratory Corporation of America over tests Labcorp had sold since 2014, and has reached settlements with Quest Diagnostics and PerkinElmer.

Ravgen has ongoing lawsuits against Roche subsidiary Ariosa, Myriad Genetics, Natera, and Biora Therapeutics, which was previously named Progenity. A company attorney previously said the company had been in negotiations with about a dozen smaller companies and had reached additional settlements without lawsuits.

The PTAB's administrative judges also delivered Ravgen a victory over Labcorp in December, and Quest ended its challenge before the board as part of its settlement with Ravgen. Blood collection tube maker Streck continues its challenge before the board regarding a Ravgen patent involving the use of an agent to inhibit cell lysis.