Sequenom v. Ariosa: The Saga Continues…

May 21, 2018

      Three years after a previous legal battle between Sequenom and Ariosa ended in a difficult loss for Sequenom (in what some commentators have characterized as a misapplication of the holding in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012)), Sequenom and its exclusive licensee Illumina have just this week filed a new patent infringement case against Ariosa Diagnostics, its parent Roche Molecular Systems, Inc. and sister company Roche Sequencing Solutions, Inc.,  in the US District Court for the Northern District of California San Francisco Division, for patents covering DNA testing in pregnant women. 

      In the complaint, Sequenom and Illumina allege infringement of Sequenom’s “Non-invasive detection of fetal genetic traits” patents (US numbers 9,580,751 and 9,738,931) by Ariosa through sale of Ariosa’s product marketed under the name ‘Harmony Prenatal Test’, which detects abnormalities including Down syndrome.  The asserted patent claims are drawn to an improved technique for preparing and analyzing extracellular circulatory DNA, with claim 1 of the ‘751 patent reading:

1. A method for preparing a deoxyribonucleic acid (DNA) fraction from a pregnant human female useful for analyzing a genetic locus involved in a fetal chromosomal aberration, comprising:

a. extracting DNA from a substantially cell-free sample of blood plasma or blood serum of a pregnant human female to obtain extracellular circulatory fetal and maternal DNA fragments;

b. producing a fraction of the DNA extracted in (a) by:

i. size discrimination of extracellular circulatory DNA fragments, and

ii. selectively removing the DNA fragments greater than approximately 500 base pairs, wherein the DNA fraction after (b) comprises a plurality of genetic loci of the extracellular circulatory fetal and maternal DNA; and

c. analyzing a genetic locus in the fraction of DNA produced in (b).

      The complaint asserts “[b]y 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.”

      Sequenom and Illumina are seeking an injunction and damages in the new suit.  It is too early to know what defenses will be asserted by Ariosa et al, or whether a post-grant review will be sought by the defendants against either of the asserted patents.  Regardless, the ongoing battle between Sequenom and Ariosa in the fetal DNA testing market continues and it will be interesting to see who prevails in this new skirmish.