San Diego's Illumina ($ILMN) announced that it is filing a patent infringement suit against Roche's ($RHHBY) Ariosa Diagnostics and its microarray-based Harmony Prenatal Test. The gene sequencing company accuses Ariosa of violating its '794 patent, called "Multiplex Nucleic Acid Reactions."
Ariosa's Harmony Prenatal Test evaluates the risk of trisomy 21 (Down syndrome), 18 (Edwards syndrome) and 13 (Patau syndrome). Trisomy occurs when there are three instances of a chromosome instead of two. The Harmony competes with Illumina's verifi Prenatal Test for the same conditions.
Ariosa says Harmony relies on a proprietary DNA-based methodology that is unique because it focuses on the cell-free DNA of the chromosomes of interest; it does not randomly test sequence all cell-free DNA. The company also says using microarray-based diagnosis instead of sequencing enables faster turnaround time and test results in as soon as 3 days.
But Illumina said patent infringement suits against Ariosa for violating the '794 patents and two others with the sequencing-based version of the Harmony Prenatal Test are still pending.
According to the U.S. Patent Office's database, the '794 patent covers an invention "that is directed to a variety of multiplexing methods used to amplify and/or genotype a variety of samples simultaneously." In addition, the filing says that "it is an object of the invention to provide a number of methods directed to the multiplexing amplification and/or genotyping reactions of target sequences to create amplicons that can subsequently be detected on an array."
An amplicon is a fragment of replicating DNA that can be formed naturally or artificially using experimental techniques like polymerase chain reaction.
This isn't the first time Illumina has filed suit to protect the intellectual property surrounding the Harmony.
In March, Illumina slapped U.K. molecular diagnostics outfit Premaitha Health and its Iona prenatal test of the same three syndromes with a patent infringement lawsuit, saying the diagnostic violates two of its patents in the U.K. for noninvasive prenatal testing of cell-free fetal DNA, which involves the use of next-generation sequencing to analyze the genetic material from a sample of maternal blood.
And in December, Illumina and Sequenom ($SQNM) settled the score in the companies' ongoing patent feud, agreeing to resolve all pending infringement claims and pool their resources to further develop noninvasive prenatal tests.
In exchange for exclusive worldwide rights to the companies' pooled noninvasive prenatal testing intellectual property, Illumina paid Sequenom $50 million upfront and committed to ongoing payments to the company through 2020.
The prenatal diagnostic industry is poised to grow to $3.6 billion by 2019, and demand for prenatal tests is set to triple over the next 6 years, according to recent market research.
- read the release
Special Report: 2014's most memorable med tech patent battles - Diagnostics: Illumina, Ariosa and Sequenom