On the 6th of December, the patent dispute over the CRISPR-Cas9 gene editing tool got underway in the first hearing at the US Patent and Trademark Office (USPTO). A queue of patent attorneys, lawyers, investors , biotech industry representatives, and journalists formed in front of the court room from 5 am, indicating the wide interest in the case involving arguably one of the most important biotech inventions of the decade.
|(c) Dana Verkouteren|
Jennifer Doudna first filed in May of 2012, before publishing their seminal article in Science, involving CRISPR-Cas9 in bacterial cells (prokaryotes). In December 2012, Feng Zhang of the Broad Institute filed his own patent, demonstrating use of the gene-editing technique in more complex eukaryotic cells, such as those found in mice and humans. The Broad Institute requested (and paid the extra fee for) expedited review for their patent application (this accelerated review process as an option for applicants is now under review by the USPTO). The USPTO awarded the Broad Institute their CRISPR-Cas9 patent in 2014, before Doudna, which is when UC Berkeley started proceedings.
The three federal patent judges present, focused their questions on two central issues: 'obviousness' and 'reasonable expectation of success.' Berkeley insists it was obvious to extend the system from prokaryote to eukaryotes, while Broad contends that there was no reasonable expectation of success by people who had ordinary skill in the art. A piece of evidence they use to back up this claim comes from Doudna herself: a press article claiming that “she experienced ‘many frustrations’ getting CRISPR to work in human cells.”
A statement from the broad institute details:
"Broad Institute, MIT and Harvard were first to invent and first to file patent applications with regard to CRISPR genome editing in eukaryotic cells. Given that the underlying facts have not changed, the Broad Institute is confident the USPTO will reach the same conclusion it did initially when it awarded these patents and will continue to recognize Broad, MIT and Harvard roles in developing this transformative technology."
According to some sources CRISPR has already attracted hundreds of millions in investments and many further research projects, not to mention general excitement about its potential from the scientific community. Recently, Chinese scientists undertook the first clinical trial of CRISPR, using it to treat patients with lung cancer. Both parties have already licensed their technology to firms (Editas and CRISP Therapeutics) whom now have to place their research is on hold until this debate is cleared up.
The hearing continues.