What are the potential applications of gene-editing technology?
In December 2016, this blog reported on an interference proceeding before the Patent Trial and Appeals Board (PTAB) regarding a dispute over who invented CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats). This breakthrough genetic technology snips away unwanted parts of genomes and replaces them with new sections of DNA.
Recently, the PTAB ruled that the there was no interference in the patents awarded to the Broad Institute of MIT and Harvard. The proceeding had been brought by scientists at the University of California at Berkeley, and the panel found that the patent claims were for distinct subject matter.
The Berkeley team initially published a report in 2012 demonstrating that they could reprogram this naturally occurring bacterial gene-editing system and applied for a patent in March 2013. That year, the Broad team showed how this technology could be used to edit the genomes of animal cells and filed for a patent application 6 months after the Berkeley filing. However, Broad paid for an expedited review and was awarded CRISPR patents in 2014 and 2015.
During oral arguments before the PTAB, the Berkeley Team challenged the patents saying that they were the first to invent the gene editing technique. However, the panel found that the Broad team’s work was sufficiently distinct and that the patents could stand. While some experts have called this a knockout punch, Berkeley is considering an appeal to the circuit court. In the meantime, Berkeley is confident its patent, which was not affected by this ruling, will also be issued.
Why This Matters?
CRISP has far reaching implications because of the potential to treat or prevent an array of congenital diseases. At the same time some bioethicists have raised alarms that gene editing could permanently alter the human species.
Nonetheless, the scientific community believes this technology will likely lead to advances in biomedicine, agriculture, public health, and environmental technologies that will ultimately benefit humanity. Also at stake are the hundreds of millions in licensing fees for CRISPR if the gene editing system becomes broadly applicable. Not only will companies seek to use the technology to develop new therapies, the financial incentives will likely lead to development of other CRISPR techniques.
In the meantime, if the Berkeley patent is issued, some observers believe that could prompt a settlement between the two parties. In any event, this will be one of the last interference proceedings since patent disputes are now handled in post-grant proceedings, a framework that was ushered in by the America Invents Act.