An appeals court has opened another chapter in the long-running CRISPR patent saga. Three years after a patent body ruled in favor of the teams behind Editas Medicine’s intellectual property, an appeals court has (PDF) found fault with the decision and sent the case back for reassessment.
In 2022, the Patent Trial and Appeal Board (PTAB) found scientists at the Broad Institute of Harvard and the Massachusetts Institute of Technology were the first to conceive of using a CRISPR-Cas9 system to edit eukaryotic cells. The ruling was a boost to Editas, which has an exclusive license from Broad, and a blow to biotechs such as CRISPR Therapeutics based on intellectual property from the losing side.
Monday, a federal appeals court reopened the argument about who invented the technology. The court said the PTAB incorrectly applied a legal standard and ordered the board to reconsider the 2022 ruling in light of its position.
The divergence between the positions of the appeals court and the PTAB centers on the importance of early uncertainty about whether CRISPR-Cas9 editing would work in eukaryotic cells. Jennifer Doudna, Ph.D., and Emmanuelle Charpentier, Ph.D., published a paper showing a CRISPR-Cas9 system worked in test tubes in June 2012, months before the Broad team’s paper about editing eukaryotic cells.
Emails show Doudna and her colleagues were discussing eukaryotic use in March 2012. Yet, the PTAB ruled Doudna and Charpentier didn’t conceive the use of CRISPR-Cas9 in eukaryotic cells because they didn’t know whether editing would work. The appeals court, in contrast, said that what matters is whether the scientists “had a definite and permanent idea,” not whether they were certain it would work.
The appeals court upheld another aspect of the PTAB’s 2022 ruling but still asked the patent board to take another look at the case. The decision throws open the question of who conceived the idea again, setting the stage for another legal deep dive into the events of 2012 leading up to the publication of the landmark CRISPR-Cas9 papers.
Editas CEO Gilmore O’Neill commented on the ruling in a statement, telling investors that the “decision does not affect our ability to license our IP, nor does it change existing licenses we have issued.” CRISPR Tx licensed CRISPR-Cas9 intellectual property from Charpentier. Caribou Biosciences has a license from the University of California, where Doudna works, and the University of Vienna.