Cancer specialist to pay $83.4m over DNA sequencing infringement

TwinStrand Biosciences and the University of Washington win patent infringement case related to DNA mutation technology.

A US district court has ruled in favour of  TwinStrand Biosciences and the  University of Washington, ordering  Guardant Health to pay US $83.4 million in damages for infringing patents.

The decision, made by the  US District Court for the District of Delaware on November 14 ruled that Guardant willfully infringed patents owned by the University of Washington and licensed to TwinStrand, which was founded by the inventors of the patents.

The patents, US numbers 10,287,631 and 10,760,127, relate to the detection of ultra-low frequency DNA mutations with a resolution 10,000x greater than conventional next-generation sequencing on the market.

The jury found that the infringement occurred through the sale of Guardant’s FDA-approved Guardant 360 CDx product, as well as all of its commercial products in cancer screening, detection, and characterisation.

Guardant CEO: Ruling ‘ignores merits of our R&D’

Helmy Eltoukhy, Guardant’s co-founder and co-CEO said: “We strongly disagree with this decision and will vigorously appeal for its overturn.

“We believe the ruling ignores the strengths and merits of our R&D and intellectual property, which we painstakingly developed for over a decade.”

The oncology company expressed its “confidence” in not infringing the patents and expects to file motions with the Delaware court and the  US Court of Appeals for the Federal Circuit.

TwinStrand’s chief executive and director,  Ron Andrews said: "We are grateful that the jury has protected the foundational duplex sequencing invention of Michael Schmitt, Jesse Salk, and Lawrence Loeb and the rights of those who own and license it, so we can continue to invest in research and development without being punished by unrestrained infringement.”

Case background

The Seattle-based company filed its lawsuit in August 2021, alleging the patent infringement of four patents in Guardant’s kits such as the Guardant360 CDx, GuardantOMNI, and the Guardant360 Response.

Simultaneously, Guardant filed three petitions to the  Patent Trial and Appeal Board (PTAB)  on two patents, with two different petitions filed challenging the validity of all 30 claims of the '127 patent on different grounds.

The PTAB refused to review the petition Guardant filed on the '631 patent and one of the petitions filed on the '127 patent.

The PTAB reviewed Guardant’s second petition on the '127 patent and rejected Guardant’s invalidity arguments for all 30 claims of the patent in its final written decision.

TwinStrand and the University of Washington were represented by a team from  Sterne Kessler Goldstein & Fox led by  Ralph Powers,  Byron Pickard,  Chandrika Vira, and  William Milliken.

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