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Myriad Denies Infringing Digital PCR Patents Held by Esoterix Genetic Labs

NEW YORK (GenomeWeb) – Myriad Genetics this week denied allegations of patent infringement levied against it in a US District Court by LabCorp subsidiary Esoterix Genetic Laboratories (EGL), arguing that its myRisk Hereditary Cancer panel and related services do not make use of the digital PCR technology covered in the intellectual property at the center of the dispute.

The legal row began in early September when EGL and Johns Hopkins University sued Myriad in the US District Court for the Middle District of North Carolina Greensboro Division for allegedly infringing four US patents covering digital PCR — Nos. 6,440,706; 7,824,889; 7,915,015; and 8,859,206 — that are assigned to the university and are exclusively licensed to EGL.

According to the suit, Myriad's myRisk Hereditary Cancer panel and services directly infringe each of the patents. For example, EGL claims the test uses methods for the detection of ratios of genetic sequences in a biological sample covered by the '706 patent; methods for the determination of allelic imbalances in a biological sample claimed in the '889 and '015 patents; and methods for the detection of a quantity of a genetic sequence in a mixed population of human genomic sequences covered in the '206 patent.

Notably, the first three patents were reexamined by the US Patent and Trademark Office in the course of a patent infringement suit EGL filed against Life Technologies in 2012. EGL said that amended versions of the patents were deemed valid by the USPTO. The companies settled that litigation in 2015.

EGL asked the court for a ruling of infringement by Myriad, a permanent injunction blocking Myriad from selling myRisk Hereditary Cancer products and services, and unspecified damages. 

In its answer to the lawsuit filed this week, Myriad refuted the charges of patent infringement. The company told the court that the myRisk Hereditary Cancer test uses RainDance Technologies' Thunderstorm next-generation target enrichment system, advanced emulsion PCR technology, and NGS technology, but that none of these are covered by the claims of EGL's IP.

Specifically, Myriad said that it uses emulsion PCR to generate PCR products that are pooled into a heterogeneous mixture before any sequencing or analysis, and that it does not perform any step that seeks to correlate the partitioned droplets that existed during emulsion PCR before the emulsion was broken to any of the pooled genetic material. Further, it said that it "does not perform any step that seeks to count the number of any particular partitioned droplets that existed during emulsion PCR before the emulsion was broken or compare such a number to any other number of partitioned droplets."

Myriad further charged that digital PCR was neither invented by the Johns Hopkins researchers listed on the '706, '889, '015, and '206 patents nor was digital PCR an "inventive concept" as of the priority dates for the patents, citing a number of publications that it said qualify as prior art.
 
As such, Myriad has asked the court to invalidate the patents, issue a ruling of non-infringement, and award it costs, attorney fees, and other relief deemed proper.