A US appeal court judgment in favour of the Broad Institute may mark the close of the long-running dispute over the US patent for the use of CRISPR/Cas9 in animal and plant cells.
The Court of Appeals for the Federal Circuit in Washington issued the ruling on 10 September 2018 after hearing arguments in April (see BioNews 948). The University of California, Berkeley (UC) brought the case, appealing the 2017 decision of the US Patent Trial and Appeal Board (PTAB) to award a patent on the use of CRISPR in eukaryotic cells to the Broad Institute of MIT and Harvard in Cambridge, Massachusetts.
The 'Board's underlying factual findings are supported by substantial evidence and the Board did not err' wrote Judge Kimberly Moore, refuting UC's claim that the PTAB 'ignored key evidence' and 'made multiple errors' when assessing whether CRISPR/Cas9 genome editing in eukaryotes was an obvious extension of their team's work.
Although UC said they are 'evaluating further litigation options', independent experts believe that they do not have grounds to appeal the decision, either at the same court or Supreme Court.
'It is very possible that there is no path forward for Berkeley in regards to broad patents covering CRISPR-Cas9 at this point,' said Professor Jacob Sherkow who specialises in patent law at New York Law School in New York City.
In 2012, researchers at UC – notably professors Jennifer Doudna and Emmanuelle Charpentier – filed a patent for their discovery of CRISPR/Cas9 and its ability to edit DNA. Subsequently, Professor Feng Zhang's team at the Broad Institute used CRISPR/Cas9 to edit the genomes of eukaryotic cells and applied for a fast-tracked patent application, which was processed before UC's.
The Patent Trial and Appeal Board (PTAB) upheld the validity of both patents in 2017 (see BioNews 889), but UC appealed, claiming that Professors Doudna and Charpentier's work provided obvious evidence that genome editing could work inside cells, and that the Broad's patent infringed theirs.
The two patents have caused confusion over who has the right to charge fees for the use of the technology, which has extremely high commercial value. According to STAT, the Broad's legal fees have exceeded US$10 million so far, a reflection of how much the institutions believe these patents are worth.
Having won, the Broad which – previously set up a patent pool to make licensing CRISPR easier (see BioNews 909) – said: 'It is time for all institutions to work together to enable the broadest possible sharing and licensing of foundational CRISPR IP [intellectual property] to accelerate research and improve human health.'