Ariosa Liable for $26 Million in Lost Profits for Infringing Two Blood Test Patents

On January 25th, a jury verdict issued in the Northern District of California awarded more than $26 million to a group of plaintiffs including San Diego, CA-based gene analysis firm Illumina, Inc. (NASDAQ:ILMN). The jury found that San Jose, CA-based molecular diagnostics firm Ariosa Diagnostics infringed upon two patents, awarding $15.7 million in lost profits to Illumina and nearly $11 million in lost profits to Redwood City, CA-based fetal and maternal health firm Verinata Health.

The jury’s lost profits award to Illumina was based on Ariosa’s infringement of U.S. Patent No. 7955794, titled Multiplex Nucleic Acid Reactions and issued to Illumina in June 2011. It claims a multiplex method for determining whether a sample contains at least 100 different target sequences for the amplification or genotyping of a variety of samples simultaneously. Verinata’s lost profits award was based on the infringement of U.S. Patent No. 8318430, titled Methods of Fetal Abnormality Detection and issued in November 2012. It covers a method for determining a presence or absence of a fetal aneuploidy in a fetus for each of a plurality of maternal blood samples received from pregnant women in a way that enables massively parallel sequencing techniques by selectively enriching non-random polynucleotide sequences in samples.

Verinata first filed suit against Ariosa jointly with the Board of Trustees of Stanford University in October 2012, alleging that Ariosa’s Harmony Prenatal Test, a prenatal test for Down syndrome, infringed on its patent by sequencing predefined subsequences of maternal and fetal DNA present in the maternal blood draw. Verinata’s patents cover methods used by the company’s Verifi prenatal test, a test performed on a maternal blood sample to determine whether a fetus is at risk of having an abnormal number of chromosomes. In August 2015, Judge Susan Illston consolidated the Verinata case with Illumina’s case, which began with a complaint for patent infringement filed by Illumina against Ariosa and Roche in May 2015. In its complaint, Illumina noted that the Harmony test involved a multiplexing method for detecting target sequences using massively parallel sequencing which allegedly constituted patent infringement.

In the recent jury verdict, both Illumina and Verinata lost on willful infringement arguments made against Ariosa during the trial. However, the validity of both patents was confirmed after being challenged by Ariosa during the case. The jury found that Illumina’s ‘704 patent was not invalid under 35 U.S.C. § 102 grounds as anticipated by prior art. Further, the jury found that Verinata’s ‘430 patent was valid despite Ariosa’s validity challenges on 35 U.S.C. § 112 grounds both for enablement and written specification.