NEW YORK – Natera and Illumina have reached a settlement for their patent infringement litigation, have signed a license agreement, and have amended their existing supply agreement, Natera said in a regulatory filing on Tuesday.
The suit, filed in the US District Court for the Northern District of California in 2018, relates to Illumina's US Patent No. 9,493,831 and Natera's US Patent No. 8,682,592. The May 8 settlement resolves all claims and counterclaims relating to noninvasive prenatal testing and pre-implantation genetic screening and diagnosis that occurred before the date of the settlement.
It does not affect the ongoing inter partes review by the US Patent and Trademark Office and the pending patent opposition proceedings against European Patent No. 3006573.
The companies also entered into a mutual licensing agreement, signed May 8 as well. As part of that agreement, Natera granted Illumina a non-exclusive, perpetual, worldwide license to intellectual property in its '592 patent family. The license is limited to certain uses of massively parallel sequencing for NIPT and PGS/PGD and excludes specific approaches, such as those used in Natera's Panorama test.
To maintain their respective licenses, each party has agreed not to challenge the validity or enforceability of the intellectual property licensed to it, subject to certain exceptions.
Natera said it retains the right to use alternative sequencing platforms for NIPT and may narrow the scope of the Natera-licensed IP if Illumina alleges infringement of its intellectual property.
Finally, Natera and Illumina have amended their 2013 supply agreement, extending it to 2030. The agreement grants Natera certain rights to Illumina's IP for NIPT on Illumina sequencing platforms, including all patents in the Illumina/Sequenom NIPT patent pool.
Starting in October, Natera's fee to Illumina for each clinical NIPT it performs using Illumina reagents will be reduced, with further reductions if volumes increase. Natera is not bound to exclusively use Illumina's sequencing instruments and reagents but may get smaller discounts from Illumina if its volume on Illumina sequencers goes down.
Illumina will also offer Natera credits for the purchase of Illumina instruments for use in oncology and organ transplant monitoring product development and will contribute Illumina products to offset a portion of Natera's new oncology product development.
The date by which Natera must obtain premarket approval for at least one in vitro diagnostic from the US Food and Drug Administration was extended to 2026 under the amendment. If it does not, Illumina may terminate Natera's rights with respect to IVDs. In addition, the amendment eliminates Illumina's right to terminate certain rights under the agreement with two years' prior notice.