31 July 2017
ByAppeared in BioNews 911
This latest appeal is part of an ongoing dispute over the US patent for CRISPR/Cas9 between the University of California (UC), and the University of Vienna and Professor Emmanuelle Charpentier, against both the Broad Institute of MIT and Harvard University (Broad/MIT) regarding who has the right to a patent on the eukaryotic application of CRISPR/Cas9 technology.
'Ultimately, we expect to establish definitively that the team led by Jennifer Doudna and Emmanuelle Charpentier was the first to engineer CRISPR/Cas9 for use in all cell types including eukaryotic cells,' stated Edward Penhoet, a special adviser on CRISPR to UC.
In 2012, researchers at UC - including Professor Jennifer Doudna and Professor Emmanuelle Charpentier – first filed a patent for their discovery of CRISPR/Cas9 and its ability to edit purified DNA in vitro. Later in 2012, a team of researchers at the Broad Institute used CRISPR/Cas9 to edit the genome of eukaryotic cells, and therefore filed for a patent based on this use.
In 2014, the US Patent and Trademark Office (USPTO) granted the patent for use in eukaryotic cells to the Broad/MIT group. Despite the UC team filing their patent claim first, the Broad group asked for 'accelerated examination' and so their application was considered first.
As a result, UC Berkeley asked for an 'interference proceeding' to reassess and determine who was the first to invent the genome editing tool.
However, in February 2017, the PTAB again ruled that the Broad/MIT group could keep its patents on using CRISPR/Cas9 in eukaryotic cells, stating that there is no interference between the two groups' patent claims – that is, the one issued to the Broad/MIT group is sufficiently different from that filed by the UC team.
The UC team are now appealing this decision, stating that the work initially performed by Professor Doudna and Professor Charpentier – although it involved characterising a purified enzyme in a test tube – provided obvious evidence that genome editing could be made to work in living mammalian cells. Thus they contend that the patent held by the Broad/MIT for this application is not novel.
The UC brief – which was issued on 25 July this year – also states that the PTAB 'ignored key evidence' and 'made multiple errors' when assessing whether CRISPR/Cas9 genome editing in eukaryotes was an obvious extension of the UC invention.
However, Jacob Sherkow, an intellectual property attorney at the New York Law School has cautioned that the UC group's brief 'overplays these mistakes relative to the PTAB's analysis.' He has added that 'while there are some interesting chestnuts in its brief - such as UC pointing out that the PTAB virtually ignored some important patents pending at the time the Broad patent was filed – I don't think that's going to be enough to win the day for UC.'
This brief will be heard by the US Court of Appeals for the Federal Circuit on 25 October 2017.