Charles River Laboratories has launched CRISPR/Cas9 services through a licensing deal with the Broad Institute, as a dispute over ownership of the gene-editing technology gathers pace.
The Massachusetts-based CRO has just launched services offering the state-of-art genome-engineering technology through an arrangement with the Broad Institute that was settled back in 2014. It means Charles River can now offer customized in vivo and in vitro genome editing which the company believes “will ultimately improve the efficiency and effectiveness of the drug discovery process.”
“[C]lients can generate custom cell lines for early, exploratory discovery research, as well as generate in vivo pharmacology models, produce those models, and then use our discovery services offering to place those models in in vivo studies,” Iva Morse, chief scientific officer for global research models and services at Charles River, said in a statement.
Charles River isn’t the only CRO eying the CRISPR/Cas9 technology, especially for its potential application in cancer treatment. In August, another contract research and manufacturing firm AMRI has also signed a similar deal licensing CRISPR techniques from the Broad Institute. Christopher Conway, AMRI’s SVP of discovery and development services, said at that time that the technology also has significant utility in drug discovery, especially drug target assessment and in vitro model development.
As of November, among all 42 CRISPR-related patents issued by the United States Patent and Trademark Office, the Broad Institute is holder of 13 of them for work led by biologist Feng Zhang. However, those patents are not ironclad, as the Cambridge, MA-based biomedical and genomic research organization is currently in a heated battle with the University of California for key patent on the genome-editing technology.
Even though Zhang was the first to receive an official patent over CRISPR/Cas9’s application in mammalian genome editing in 2014 after a request for an expedited process, it was biochemist Jennifer Doudna from the University of California, Berkeley, who first submitted the patent application for the core CRISPR technology back in 2012.
As both parties claim to be the inventor of the potentially lucrative technology, and because the time for original patent filings fall before the March 16, 2013 deadline when the country officially shifted from a first-to-invent system to an internationally accepted first-to-file system, a standard interference proceeding was initiated. The first open-to-public oral arguments session took place yesterday before three USPTO judges.
The entire process is going to be complicated, the evidence is not clear enough to reach a conclusion, and the final verdict could take months, or even years, to come, and as the stake is quite high—millions of dollars in licensing fees could be generated for the organization who holds the key patents—it will be no surprise that the losing team will appeal.
Right now, application of CRISPR has already entered the clinical stage, with a team of Chinese scientists at Sichuan University started trials of it on a cancer patient in November, beating a number of institutes and companies in the U.S. More are slated to come in 2017, and the race for approval has just started.