• Sat. Jul 13th, 2024

Guardant Health files suit against Tempus AI | Biotechnology

Biotech takes legal action against Tempus AI, alleging patent infringement in Tempus’s liquid biopsy products | Complaint accuses Tempus of unauthorised use of Guardant’s tech crucial for cancer diagnostics.

Guardant Health has filed a lawsuit against Tempus AI, alleging that its liquid biopsy products infringe five patents.

The complaint, filed at the US District Court for the District of Delaware, accuses Tempus of unauthorised use of Guardant’s patented technologies, which are critical for cancer diagnostics.

The Palo Alto-based biotech’s suit concerns US patent numbers: 11,149,306; 9,902,992; 10,501,810; 10,793,916; and 11,643,693.

These patents cover methods and systems for detecting genetic variants, crucial for non-invasive cancer diagnostics using blood samples.

Guardant’s technology allows for comprehensive cancer screening and monitoring through simple blood draws, offering an advantage over invasive tissue biopsies, said the suit.

The precision oncology company asserted that Tempus’ products, which include the Tempus xF and xF+ panels, use methodologies protected by Guardant’s patents.

These products detect mutations and genetic alterations in cancer patients’ blood samples, a process Guardant claimed to have pioneered and protected through extensive R&D efforts.

Guardant argued the AI healthcare company’s alleged infringement of the patents-in-suit has caused and is causing ongoing harm to its business.

Consequently, Guardant sought monetary damages from Tempus and requested a court order to prevent further alleged infringement of its patents.

Tempus accused of ‘monitoring’ actions

Guardant said it has been at the forefront of developing liquid biopsy tests, including the FDA-approved Guardant360 CDx.

These tests analyse circulating tumour DNA (ctDNA) in blood to provide critical insights into cancer genomics, offering a less invasive and faster alternative to traditional tissue biopsies.

Tempus, established in 2015, has developed several liquid biopsy products, such as Tempus xF, Tempus xF+, and Tempus xM Monitor, which Guardant claimed infringe on its patents.

According to the suit, Tempus has monitored Guardant’s IP and continued to develop similar technologies, potentially violating Guardant’s patent rights.

Guardant argued that Tempus’ success with its liquid biopsy panels is built on the unauthorised use of Guardant’s inventions.

The complaint highlighted that Tempus’s S-1 filing acknowledged the ongoing patent litigation in the liquid biopsy field and the potential impact on their business operations.

Guardant’s litigation history

Last year a US district court 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 November 2023 decision, delivered by the District Delaware court, 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 related 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.

In January 2024, the US Patent Trial and Appeal Board upheld the ‘306 patent belonging to Guardant Health, determining that TwinStrand had failed to show its claims were unpatentable.

The judgment dismissed a challenge to Guardant’s patent from Seattle-based TwinStrand, which had said claims 1-29 were invalid as obvious.

Judges Hulse and Valek acknowledged the prior art references to the ‘306 patent that formed the basis of TwinStrand’s contention, but were not convinced that they rendered any of the claims obvious.

They denied Guardant’s motions to strike the declarations of certain TwinStrand witnesses, and exclude “newly introduced exhibits” it said were “irrelevant”, but this did not affect their finding that the patent was valid.

Guardant was represented in its case against Tempus by Jordan Jaffe, Wendy Devine, Michael Rosato and Eric Tuttle from Wilson Sonsini Goodrich & Rosati.

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