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US Appeals Court Upholds Invalidation of Columbia University Sequencing Chemistry Patents

NEW YORK – A US appeals court has upheld the invalidation of five patents covering next-generation sequencing chemistry held by Columbia University.

In an opinion released Monday, the US Court of Appeals for the Federal Circuit affirmed the US Patent and Trademark Office's Patent Trial and Appeals Board (PTAB) 2019 decision to invalidate US Patent Nos. 9,718,852; 9,719,139; 9,708,358; 9,725,480; and 9,868,985, all covering nucleotide analogs and their use in sequencing-by-synthesis. The invalidations were the result of several inter partes review (IPR) proceedings initiated by Illumina from 2017 to 2018.

The PTAB found that the patents would have been obvious given certain combinations of prior art. Columbia University appealed, challenging the determination that a person of ordinary skill in the art would have been motivated to pursue the claimed inventions or would have had a reasonable expectation of success.

The decision is a blow to a 2017 lawsuit filed by Columbia against Illumina, alleging infringement of the '358 patent.

Columbia University declined to comment; through an attorney, Illumina declined to comment.

The two parties have been embroiled in litigation over NGS technology for the better part of a decade. Columbia first sued Illumina in 2012, alleging infringement of four patents related to NGS chemistry, none of which were involved in the recent appeal. Illumina countersued and also sued Qiagen, which had licensed patents from Columbia.

Last year, Illumina initiated IPR proceedings over five more patents held by Columbia University, US Patent Nos. 10,407,458; 10,407,459; 10,457,984; 10,435,742; and 10,428,380 — all titled "Massive parallel method for decoding DNA and RNA." Over the last two months, the PTAB has instituted IPR for all five patents.

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