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Myriad, Bio-Rad, RainDance File for Inter Partes Review of Johns Hopkins Digital PCR Patents

NEW YORK (GenomeWeb) – Myriad Genetics, Bio-Rad Laboratories, and RainDance Technologies recently filed petitions with the US Patent and Trademark Office's Patent Trial and Appeal Board requesting inter partes review of four Johns Hopkins University patents related to digital PCR.

The parties are asking the USPTO to cancel several claims in these patents as anticipated and obvious. "The steps comprising what [JHU] calls 'digital PCR' were well known in the art before the earliest possible priority dates of the claims," Myriad, Bio-Rad, and RainDance wrote in their petitions.

These petitions are the latest move in a legal battle that began in the fall of 2016, when Laboratory Corporation of America subsidiary Esoterix Genetic Laboratories and JHU sued Myriad in the US District Court for the Middle District of North Carolina Greensboro Division alleging infringement of US Patent Nos. 6,440,706; 7,824,889; 7,915,015; and 8,859,206.

These patents were assigned to JHU and are exclusively licensed to EGL, and the plaintiffs claim that Myriad's myRisk Hereditary Cancer panel and services directly infringe them.

The first three patents were reexamined by the USPTO during a 2012 lawsuit EGL filed against Life Technologies. At that time, USPTO deemed amended versions of these patents valid, EGL says, and the parties settled that case in 2015.

In its lawsuit against Myriad, EGL asked the court for a ruling of infringement, a permanent injunction blocking Myriad from selling myRisk products and services, and unspecified damages. At the same time EGL sued Myriad last year, it also sued Ambry Genetics alleging infringement of the same four patents in its hereditary cancer risk testing services.

Myriad has maintained throughout that Esoterix's claims lack merit and the patents are invalid. Myriad has previously said in court filings that myRisk uses RainDance's Thunderstorm next-generation target enrichment system, advanced emulsion PCR technology, and next-generation sequencing technology, but that none of these are covered by the claims of JHU's IP. Rival droplet-based PCR manufacturer Bio-Rad announced in January that it would acquire RainDance, a transaction that was completed in February for for an estimated $87 million plus certain assumed net liabilities.

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