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Illumina, Molecular Loop Sue Each Other Over Church Lab NGS Library Prep Patents

NEW YORK – Illumina and Molecular Loop have fired the opening salvo in an intellectual property dispute about unique barcoding technology used in sequencing library preparation.

Woburn, Massachusetts-based Molecular Loop holds patents to technology developed in George Church's lab at Harvard Medical School. On Tuesday, it sued Illumina in the US District Court for the District of Delaware alleging infringement of five of these patents, including US Patent Nos. 11,041,852, "Methods for Maintaining the Integrity and Identification of a Nucleic Acid Template in a Multiplex Sequencing Reaction" and 11,840,730, "Methods and Compositions for Evaluating Genetic Markers."

Molecular Loop alleges that Illumina subsidiary Verinata Health's Verifi and VeriSeq tests, as well as Illumina's TruSight Oncology 500 family of tests, infringe the patents-in-suit. It asked for a judgment of willful infringement, damages and fees, a permanent injunction or licensing fee, and a jury trial.

That followed a preemptive strike from Illumina on Monday asking the US District Court for the District of Massachusetts to declare noninfringement of the five patents. Illumina also asked the court to declare unenforceability of the '730 patent, including for inequitable conduct before the US Patent and Trademark Office by Molecular Loop CEO and Cofounder Greg Porreca, an inventor on the patents.

"Molecular Loop's patented technology is being increasingly used in commercial next-generation sequencing applications," the firm said in a statement. "Molecular Loop strongly prefers to license its technology, and has tried and remains open to doing so with Illumina. But Molecular Loop will litigate to protect its patent rights when needed," adding that it believed Illumina's allegations were without merit. Illumina declined to comment on the suits.

Church, whose lab has developed numerous sequencing technologies, is a coinventor on at least two of the patents held by Molecular Loop. According to Molecular Loop's suit, Porreca did his doctorate under Church at Harvard.

According to Illumina, one of the patents has an application dating back to as early as 2009.

Illumina also alleges that since January, Molecular Loop has sent letters to several Illumina customers — including Ambry Genetics, ARUP Laboratories, Fulgent Genetics, NeoGenomics Laboratories, Helix, Tempus Labs, and Personalis — implying that they have infringed the patents "at least partially as a result of using certain kits containing unique molecular identifiers and/or unique dual indices they have purchased from [Illumina]."

In Wednesday afternoon trading on the Nasdaq, shares of Illumina were down 3 percent at $109.58.