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Illumina and Roche settle and dismiss patent lawsuits over 'Harmony' tests

1 June 2021
Appeared in BioNews 1097

A long-running court case over non-invasive prenatal testing (NIPT) patents has been settled.

Roche Holding AG and Illumina Inc settled their dispute which had been ongoing since 2014 when Verinata Health (later acquired by Illumina) sued Ariosa Diagnostics (later acquired by Roche) for patent infringement. 

The parties filed a joint court document stating that the 'Plaintiffs and Defendants have mutually agreed to a settlement of Plaintiffs' and Defendants' respective claims' and asking the court to 'dismiss with prejudice' the claims of patent infringement and to 'dismiss without prejudice' the counter-claims. The terms of the settlement were not made public.

The matter arose from an alleged patent infringement over a  sequencing-related blood test to identify fetal abnormalities.

NIPT is a blood test used to detect genetic abnormalities in a fetus during pregnancy. Unlike older techniques such as amniocentesis and chorionic villus sampling, it does not increase the risk of miscarriage because the fetal DNA is detected from the mother's blood rather than having to take a sample from the amniotic fluid or placenta. 

Many of the patents being disputed relate to separating the fragments of maternal and fetal DNA in the blood sample and then sequencing and assembling them to get an overview of the fetal genome. 

The settlement brings to an end several related cases including the original claim, and another where Illumina and a company called Sequenom sued Ariosa for two patents relating to 'the cutoff length for enriching the fraction of fetal DNA in a blood sample from the mother'. Ariosa claimed that 'the difference in length between most maternal DNA and most fetal DNA was a natural law' and therefore could not be patented. 

The Sequenom case had been due to be heard by the US Supreme Court, who would have been able to rule on what is and is not patentable, but this will no longer happen as the cases have been settled. However, the issue may still continue as Illumina has ongoing cases against Natera and Premaitha Health for similar infringements of NIPT-related patents.

Illumina, Inc. v. Ariosa Diagnostics, Inc.
Court Listener |  26 May 2021
Illumina, Roche agree to settle NIPT patent lawsuits
Genomeweb |  26 May 2021
Roche, Illumina to settle decade-long fight over prenatal tests
Bloomberg |  24 May 2021
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