Credit: Oxford Nanopore Technologies

A patent lawsuit against Oxford Nanopore Technologies (ONT) that was raised by Pacific Biosciences (PacBio) in November 2016 has officially been ruled in favour of ONT.

The complaint was filed with the International Trade Commission (ITC) on the grounds that ONT was infringing on two of PacBio’s patents, something which would have prevented ONT from selling their products in the USA. The alleged infringement related to the use of a ‘hairpin adaptor’ when performing 2D sequencing on ONT’s MinION sequencer. According to PacBio, the nature of this process was in violation of the US patents 9,404,146 and 9,542,527. 

At the time, PacBio’s CEO Michael Hunkapiller said, “As a pioneer in the field of single-molecule, long-read sequencing, we have invested hundreds of millions of dollars in research and development across a broad array of disciplines, including nanofabrication, physics, organic chemistry, photonics, optics, molecular biology, engineering, signal processing, high-performance computing, and bioinformatics. We stand firm in our resolve to protect that investment and our leadership position in the field we have created.”

Yesterday, the ITC announced their Final Determination, which states that ONT has not infringed on the patents in question. Their decision was made as a result of their interpretation of the term ‘single molecule sequencing’, which they believed to be limited to sequencing by synthesis approaches, such as those used by PacBio. As ONT’s sequencers do not rely on synthesising DNA in the sequencing process, they were subsequently not covered by the two patents in question. 

With the conclusion of the matter, the ITC have terminated the investigation. This ruling leaves ONT free to continue selling their products to the American market.

In response to the news, Gordon Sanghera, ONT’s CEO, said, “We are pleased that Pacific Biosciences has failed, in this action, to prevent Americans choosing and benefiting from Nanopore single molecule, real time DNA sequencing.”

Pacific Biosciences have also reacted to the news. 

“We disagree with the present determination of non-infringement in this lawsuit, and note that the ITC’s construction of the term ‘single-molecule sequencing’ is inconsistent with both the commonly understood meaning of that term as well as relevant U.S. Supreme Court and Federal Circuit precedent,” Dr. Hunkapiller said in a statement. “We continue to stand firm in our resolve to protect our investment and leadership position in the field we have created, and we look forward to the next phases of our litigation against Oxford Nanopore in the U.S. and Europe.”

While this ruling is an important victory for ONT, this is unlikely to be the end of legal proceedings between the two companies. PacBio retains the right to appeal this judgement through the US Court of Appeals, as well as maintaining a string of other lawsuits that are currently underway. In the USA, a further three PacBio patents that refer to aspects not covered under 146 or 527 are under dispute, and in Europe, the company are currently pursuing complaints regarding 2D sequencing in the High Court of England and Wales, and in the District Court of Mannheim in Germany. In reaction to these lawsuits, ONT filed a suit of their own against PacBio in April 2017, also through the District Court of Mannheim. 

This news comes less than 24 hours after ONT hosted an online technical update with their CSO, Clive Brown, which discussed their plan moving forwards, including a pathway to a sub-$1k genome with PromethION. The update was also used to officially announce the Flongle (a flow cell dongle) that can act as an adaptor for MinION and GridION to enable the use of smaller, single-use flow cells, as well as the launch of their pre-configured IT solution, MinIT.

ONT’s Illustrious Lawsuit History:

  • February 2016 – Illumina file a lawsuit against ONT, claiming that the bacterial nanopore (R7) that was ‘most likely’ used in their sequencers infringed on a patent held by researchers at Illumina. ONT’s CEO, Gordon Sanghera, responded to the suit with characteristic good humour, saying, “It is gratifying to have the commercial relevance of Oxford Nanopore products so publicly acknowledged by the market monopolist.”
  • March 2016 – ONT announce a new set up for their MinION and PromethION sequencers that uses a different nanopore with better performance, R9, for which they hold a patent.
  • August 2016 – Illumina and ONT settle their lawsuit, without payment from either party. Consumables from ONT’s sequencers using R7 have already been made unavailable and are replaced by consumables using R9.
  • November 2016 – PacBio begin the first of their lawsuits against ONT, starting with the latter’s hairpin adaptor. The adaptor is used in 2D sequencing, a technique that sequences both strands of a DNA fragment; 2D sequencing takes longer than 1D but is more accurate.
  • March 2017 – PacBio launch a second lawsuit against ONT regarding the detection method their sequencers used when DNA was passed through the nanopore. Again, Sanghera was flippant about the matter (and his own puns), writing, “It’s another pore excuse for a lawsuit. We believe this is another frivolous lawsuit brought by a competitor nervous about our superior technology. I would like to assure all our customers that this and other actions will not disrupt our commercial operations.”
  • April 2017 – ONT hit back at PacBio with their own lawsuit in the European courts, titled ‘Molecular and Atomic Scale Evaluation of Biopolymers.’
  • May 2017 – ONT hold their annual conference, London Calling 2017. Amongst a whole host of new announcements (and the hugely impressive smartphone sequencing), ONT’s CTO Clive Brown reveals the move from 2D sequencing to 1D2 sequencing, which was said to combine the simple preparation stage of 1D sequencing and the accuracy of 2D.
  • May 2017 – A released document reveals that many of the disputed claims in PacBio’s lawsuits have been ruled in favour of ONT.
  • September 2017 – PacBio launch their third lawsuit against ONT, this time with a claim that will cover both 2D and 1D2 sequencing. Neither company has commented. 
  • February 2018 – The International Trade Commission announce their ruling on the November 2016 PacBio suit, stating that ONT have not infringed on any patents and dropping the investigation.

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