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14 May 2020Big Pharma

Natera and Illumina settle litigation, agree mutual licence

Natera has agreed to license Illumina IP covering non-invasive prenatal testing (NIPT), in a deal that sees the pair settle all outstanding patent litigation over the technology.

The announcement came in a Natera filing at the US Securities Exchange Commission (SEC) on Friday, May 8.

Illumina sued Natera for patent infringement in 2018 at the US District Court for the Northern District of California. The Illumina patent (number 9,493,831) covers NIPT library preparation. Natera responded with counterclaims of its own, accusing Illumina of infringing patent number 8,682,592.

The parties have now reached a settlement and mutual licensing deal, with Illumina granting Natera rights to its sequencing platform, including all IP in a NIPT patent pool operated by Illumina and Sequenom.

“The fees payable by Natera to Illumina for each clinical NIPT test that Natera performs using Illumina reagents will be reduced, beginning in October 2020, with further reductions with increases in volume,” the SEC filing stated.

In turn, Natera will license the IP related to its ‘592 patent to Illumina on a non-exclusive, worldwide basis.

The licence covers use of “massively parallel sequencing” in NIPT, with exceptions like the technology underpinning Natera’s Panorama NIPT platform.

“In order to maintain their respective licenses, each party has agreed not to challenge the validity or enforceability of the intellectual property licensed to it, subject in each case to certain customary exceptions,” the regulatory filing said.

The IP for NIPT has been fiercely contested, with Illumina having been drawn into patent disputes with companies including Sequenom, TDL, Roche, and Genoma in recent years.

Illumina recently won a key victory at the US Court of Appeals for the Federal Circuit, which held that two of its fetal DNA detection patents were valid. The decision was a reversal of the US District Court for the Northern District of California, which had previously ruled in favour of Roche.

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