The U.S. Patent agency on Tuesday will hear arguments in a heated dispute over who was first to invent a revolutionary gene-editing technology known as CRISPR.
Hundreds of millions of dollars may be at stake, as the technology promises commercial applications in treating genetic diseases, engineering crops, and other areas.
CRISPR works as a type of molecular scissors that can trim away unwanted parts of the genome, and replace them with new stretches of DNA. It has quickly become the preferred method of gene editing in research labs because of its ease of use compared with older techniques.
The hearing is before the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board in Alexandria, Va. It will pit one group of researchers associated with the Broad Institute, affiliated with the Massachusetts Institute of Technology and Harvard University, against another group linked to the University of California at Berkeley and the University of Vienna in Austria.
The latter team, led by Berkeley’s Jennifer Doudna and Vienna’s Emmanuelle Charpentier, applied for a CRISPR patent in 2013.
The Broad team, led by MIT’s Feng Zhang, filed a patent application months later, and became the first to obtain a CRISPR patent in 2014. It has since obtained additional patents. The Berkeley team has obtained CRISPR patents as well, though the 2013 application has not been granted.
In April 2015, the Berkeley team petitioned the patent agency to launch a so-called interference proceeding, claiming Broad’s patents covered the same invention as the Berkeley team’s 2013 application.
Tuesday’s hearing will focus on preliminary motions, which the panel is expected to decide within the next few weeks.
One of those motions, filed by Broad, could end the case. Broad has argued that its patents, which describe the use of CRISPR specifically in animal cells, represent a breakthrough beyond the Berkeley team’s application, which described it more generally. CRISPR occurs naturally in bacteria.
The two teams, Broad has said, are not really claiming the same invention at all. If the panel agrees, the interference proceeding will end, and Broad’s patents will remain intact. Rulings from the panel can be appealed in federal court.
Otherwise, the proceeding will likely go on for another year or more, as the panel weighs evidence to determine which team was first to invent the technology.
Broad spokesman Lee McGuire said in a statement that the institute was confident of its case. Berkeley representatives could not be reached for comment.
The CRISPR dispute is among the last-ever interference proceedings, which were phased out by a 2011 patent reform law. The America Invents Act changed the U.S. Patent system from a “first to invent” to “first inventor to file” for patent applications after March 16, 2013.
If the Berkeley team’s challenge succeeds, Broad could lose its patent rights.
Broad has already licensed its CRISPR patents for human therapeutics research to Editas Pharmaceuticals, a Cambridge, Mass.-based biotech firm whose founders included both Zhang and Doudna, who has since left.
It has also licensed its technology to large businesses, including agriculture company Monsanto and General Electric’s medical technology subsidiary GE Healthcare.
Doudna co-founded Berkeley biotech firm Caribou Biosciences, which licenses Berkeley’s intellectual property and is working on CRISPR with other companies, including Novartis AG and Dupont.
The case is The Broad Institute Inc v. Regents of the University of California, Patent Interference No. 106,048.