On December 6, the U.S. Patent and Trademark Office began hearing arguments from The University of California, Berkeley and the Broad Institute, a joint collaborative effort between the Massachusetts Institute of Technology and Harvard University, regarding the intellectual property ownership of the gene editing method known as the CRISPR/Cas system. UC Berkeley was the first to file a patent for this method, while the Broad Institute has previously won multiple awards regarding its research on this system and has filed multiple patents on the methods of this technology.
CRISPR, or clustered regularly interspaced short palindromic repeats, associated with Cas9, or bacterial CRISPR-associated protein-9 nuclease, allows molecular researchers to make precise and targeted changes to the genome of live cells. Many believe this technique will allow researchers to more efficiently study an organism’s response to the elimination of genetic material.
The main area of dispute in this case involves the wording used in the UC Berkeley patent application. Lawyers for UC Berkeley argue that researcher Jennifer Doudna, an ASBMB member, and her collaborator Emmanuelle Charpentier were the first to perform the technique in prokaryotes and simple organisms, publishing their results in the journal Science on June 28, 2012. However, in a 2012 interview Doudna stated that she wasn’t sure if this method would be applicable in eukaryotic cells.
Since April 2014, the Broad Institute has received 13 CRISPR patents, led by researcher Feng Zhang. The Zhang team’s work has led to the application of this technology in eukaryotes, publishing their work in the journal Science on February 15, 2013. The Broad Institute argues that nowhere in UC Berkeley’s patent application did they take the pathway from bacterial cells and apply it to eukaryotic cells, while UC Berkeley argues that the transition from simple to complex organisms was a no-brainer.
This dispute could have a broad impact on the future of biotechnology IP cases as universities place increased importance on licensing and revenue from new technologies. If the patent is awarded to UC Berkeley, the Broad Institute could be stripped of their multiple CRISPR patents, resulting in the loss of hundreds of millions of dollars from companies that invested in the Broad Institute technology. Alternatively, companies that have invested in the UC Berkeley application stand to profit if the patent war tips in the favor of UC Berkeley.
This hearing is extremely rare and complex in the world of biotechnology, and sheds more light on the 2013 America Invents Act where patent application wording was changed from “first to invent” to “first to file.” A ruling is expected in the coming weeks. However, due to the high-profile nature of this technology, and the revenue involved, this dispute may not be over until all appellate court routes are exhausted.
We will keep you updated as more information becomes available.