CRISPR Nobel laureates win latest round of patent dispute

A long-running legal battle over patent rights for the Nobel-prize-winning CRISPR/Cas9 approach to genome editing has reignited.

The Court of Appeals for the Federal Circuit has directed the US Patent Trial and Appeal Board (PTAB) to reconsider its previous decision that Professor Feng Zhang's team at the Broad Institute, Boston, Massachusetts, pioneered CRISPR/Cas9 genome editing in eukaryotic cells. The court concluded that the Board applied the wrong legal standards in its 2022 decision to dismiss the challenge brought by Professor Jennifer Doudna of the University of California, Berkeley, and Professor Emmanuelle Charpentier of the Max Planck Unit for the Science of Pathogens in Germany, who first demonstrated that CRISPR/Cas9 could be used for genome editing. This marks a new turn in a long running legal dispute over patent rights (see BioNews 1031, 967 and 954).

The three-judge panel presiding over the appeal concluded, 'We vacate the Board's determination as to conception and remand for further proceedings. On remand, we instruct the Board to reconsider the issue of conception in a manner consistent with this opinion.'

CRISPR/Cas9 has been widely used for genome editing across science, health and agriculture since its development in 2012. Professor Doudna and Professor Charpentier shared the Nobel Prize in Chemistry in 2020 for first demonstrating its efficacy on DNA in test tubes (see BioNews 1070). Subsequently, its use in eukaryotic cells including mouse and human cells were detailed by Professor Zhang in his 2013 paper published in Science, and the Broad Institute was awarded a patent for this use of the technology in 2012.

The legal battle concerned who was the first to conceive the idea to use CRISPR/Cas9 in eukaryotic cells. In 2022, the team including professors Doudna and Charpentier provided evidence of their researchers discussing eukaryotic use via email correspondence in early 2012. However, PTAB ruled this was insufficient to make the case for priority as they did not know whether it would be successful. The Broad Institute highlighted in its statement that the original patents were awarded for work that began in early 2011 that culminated with Professor Zhang's paper in 2013.

The court concluded that in 2022 the Board failed to consider relevant evidence and applied incorrect legal standards, in part because the research team should not have been required to know for certain that the technique would work.

Jeffrey Lamken, an attorney representing the team including professors Doudna and Charpentier, said: 'Today's decision creates an opportunity for the PTAB to reevaluate the evidence under the correct legal standard and confirm what the rest of the world has recognised: that the Doudna and Charpentier team were the first to develop this groundbreaking technology for the world to share.'

Following the court decision, the Broad Institute said in a statement, 'Broad is confident the PTAB will reach the same conclusion and will again confirm Broad's patents, because the underlying facts have not changed.'

The Board is expected to reconsider the evidence to reach a decision.