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Genmark, ViroNovative Settle Patent-infringement Dispute

NEW YORK (GenomeWeb) – A years-long legal battle between Genmark Diagnostics and ViroNovative has been settled, putting an end to a dispute over whether Genmark's eSensor Respiratory Virus Panel infringed ViroNovative's intellectual property related to the detection of human metapneumovirus.

Rob Posthumus, ViroNovative's legal counsel, told GenomeWeb that the companies have signed an agreement, under which ViroNovative licensed to Genmark the IP at the center of the row. They also have agreed to dismiss lawsuits filed against each other. He declined further comment.

Human metapneumovirus, or hMPV, is a negative single-stranded RNA virus that causes upper and lower respiratory tract infections. It was first identified in 2001 at Erasmus Medical Center in the Netherlands, which licensed related IP to ViroNovative when it was spun out of the academic hospital the following year.

In 2012, Genmark received US Food and Drug Administration approval for the Respiratory Virus Panel, which runs on the company's eSensor XT-8 multiplex molecular diagnostics system and can simultaneously detect and differentiate 14 clinically relevant viruses, including hMPV, in a single sample from patients with influenza-like illness.

While the company markets a number of different tests, Genmark President and CEO Hany Massarany noted earlier this year that the Respiratory Virus Panel represents one of the main drivers of XT-8 placements and the company's revenue growth.

In mid-2014 Genmark filed a lawsuit in the US District Court for the Southern District of California to have patents held by ViroNovative invalidated, and asked for a ruling that it does not infringe that company's IP. The suit was later expanded to include MedImmune, which holds the exclusive rights to ViroNovative's hMPV IP for therapeutic applications.

In its complaint, Genmark alleged that it received a "'take or leave it' demand" and threats of patent enforcement if it did not agree to proposed licensing terms. In response, ViroNovative asked the court to dismiss the case.

While that litigation wound its way through the court, in January this year the US Patent and Trademark Office granted ViroNovative US patent No. 8,927,206, which covers the diagnosis of hMPV infection using an RT-PCR approach to amplify and detect at least a portion of the virus' nucleocapsid (N) gene.

On the same day it received that patent, ViroNovative filed its own suit against Genmark, alleging that its Respiratory Virus Panel infringes the '206 patent because it uses the N gene as the "specific gene target for detection of hMPV."

ViroNovative also stated in its suit that Genmark knew of the '206 patent and that it "knowingly induced" customers to infringe the patent by providing them with training, technical support, and reagents to assist in use of the Respiratory Virus Panel.

ViroNovative was seeking a ruling that Genmark was infringing its patent, an injunction preventing the sale of the respiratory virus test, and undisclosed damages.

However, last week both Genmark's and ViroNovative's lawsuits were voluntarily dismissed with prejudice.