CRISPR-Cas9, the gene-editing technology co-invented by a UC Berkeley professor, is again in the courts, as the University of California fights the Broad Institute, Harvard University and the Massachusetts Institute of Technology, or MIT, over patent rights that could yield billions.
On Monday, the three judges of the U.S. Court of Appeals for the Federal Circuit heard oral arguments in the CRISPR patent case between the university and the Broad Institute, which is representing both the Harvard and MIT patent claims. The entity that wins the dispute could secure not only prestige but also billions of dollars in licensing agreements.
Campus professor of molecular biology and chemistry Jennifer Doudna discovered the CRISPR-Cas9 technology along with Emmanuelle Charpentier, a former professor at the University of Vienna. CRISPR has the potential to save thousands of lives, as researchers apply the technology to human embryos and begin clinical trials for conditions such as sickle cell disease.
Though UC Berkeley received patent rights for CRISPR, the Broad Institute, Harvard and MIT have patented its applications to eukaryotic cells — rights that the UC challenges. The university argues that the application to eukaryotic cells is “obvious” and cannot therefore receive a separate patent, according to a UC press release.
In February 2017, however, the U.S. Patent Trial and Appeal Board, or PTAB, ruled against the UC, a decision the university filed to appeal.
“The PTAB committed several legal errors, including disregarding Supreme Court and Federal Circuit precedent,” said the UC’s lead attorney Donald Verrilli Jr. in a UC press release. “Those errors led the PTAB to disregard the fact that once the Doudna-Charpentier team disclosed the CRISPR-Cas9 invention, they, along with Broad and four other groups, were quickly able to use conventional, off-the-shelf tools to employ CRISPR-Cas9 to cleave DNA in eukaryotic cells.”
The Broad Institute said it was “even more confident” in its case after today’s oral arguments, according to its press release. It argues that PTAB’s decision to uphold the eukaryotic patents is consistent with both the law and the evidence presented.
The onus of proof for the case lies with the UC, meaning that it, not the Broad Institute, must convince the three judges of the appellate court that the eukaryotic patent interferes with the original patent.
Neither Doudna nor the attorneys from the UC and the Broad Institute were available for comment by press time.
“We presented compelling arguments today that the PTAB committed several legal errors,” said Charles Robinson, general counsel and vice president of legal affairs at UC Office of the President, in a statement. “Based on the questioning today, we are optimistic that the court has serious doubts about several aspects of the PTAB’s decision.”