Oral arguments from lawyers acting for the Broad Institute of MIT and Harvard and the University of California (UC), Berkeley, in the high-profile CRISPR/Cas9 patent dispute have been heard in Virginia.
As part of the patent interference procedure initiated by UC Berkeley last year, the parties were given 20 minutes each to present their arguments on the issue of who first invented the genome-editing technique (see BioNews 802 and 835). The judges have already considered hundreds of documents filed by both sides.
Patent rights over the use of CRISPR/Cas9 were awarded to Professor Feng Zhang at the Broad Institute in April 2014. This decision was contested, however, by UC Berkeley, which argued that Professor Jennifer Doudna, working alongside Professor Emmanuelle Charpentier, published a paper in 2012 describing the technique and as such were the first to invent the technology. It also claimed that earlier patents filed by Professor Doudna and colleagues covered the use of the technique in question.
UC Berkeley is asking the US Patent and Trademark Office (USPTO) to invalidate or redact Professor Zhang's core patents in relation to CRISPR/Cas9, a decision that would have significant financial implications for both sides.
Acting for UC Berkeley, Todd Walters of the law firm Buchanan Ingersoll & Rooney, explained to the judges that Professor Doudna's paper and subsequent provisional patent application identified the key components of CRISPR/Cas9 and its use for altering the DNA of bacteria (or prokaryotes).
Walters asserted that, once the technique was shown to work in bacteria, it would then be obvious to a reasonable person skilled in that field that it could be used in more complex (eukaryotic) cells. As such, Professor Doudna and Professor Charpentier's work covers aspects of Professor Feng's patent, which is concerned specifically with the use of CRISPR/Cas9 in eukaryotic cells.
Representing the Broad Institute, Steve Trybus of Jenner and Block argued that Professor Doudna had struggled to get the technique to work in eukaryotic cells, and pointed out that she did not manage to do so until months after the initial work in prokaryotes. 'That is the antithesis of something that would have been obvious', he said.
On the other hand, Walters had said getting the technique to work in eukaryotic cells was so obvious that six different teams had managed to do so within six months of Professor Doudna's publication.
Commenting on the proceedings, a special adviser for technology transfer at the National Institutes of Health, Dr Mark Rohrbaugh – as reported in The Scientist – explained that the issue for the judges was about 'obviousness': 'Was this the system that just happened to successfully easily move from a prokaryotic to eukaryotic system? Were they just lucky in that? Or was it predictable and obvious based on the prior art that it could move from one system to the other?'
The Scientist adds there were other issues in contention, including differences in the molecules used and the approach taken by the researchers. It may be that, following the outcome of the interference proceedings, some patent claims held by the Broad Institute would remain intact while others could be awarded to UC Berkeley.
The Wall Street Journal explains that patent interferences typically involve two stages. The first involves arguments that attempt to invalidate a patent – as UC Berkeley has sought to do. The second involves determining the date of priority – the USPTO will still need to decide if the relevant date of filing is the provisional or final applications submitted by the parties.
Although there is no timeline for when the USPTO must give its verdict, some experts have indicated a decision on the first stage of proceedings will be made before February 2017.