UC battles to regain rights to CRISPR technology
School system argues that patents on gene-editing tool belong to it, not Broad Institute of Harvard and MIT
The University of California is fighting back in its quest to regain control over the rights to the powerful gene-editing technology known as CRISPR-Cas9.
On Monday, in a case before the United States Court of Appeals for the Federal Circuit in Washington, D.C., UC asserted that the valuable patents on the revolutionary tool belong to UC, not the Broad Institute of Harvard and MIT — and that the nation’s patent office committed serious legal errors when it ruled in 2017 against the University of California.
It’s a high stakes showdown over intellectual-property rights between two of the nation’s most prestigious institutions, with perhaps a billion dollars in the balance.
While research universities often reach settlements over patent disputes, both sides in this CRISPR case have engaged in a long, vitriolic and expensive patent fight.
On Monday, UC clearly failed to win over at least one of the three judges, according to observers. The federal circuit has to give deference to the factual determinations of the Patent Board, so, in only 15 minutes, UC had to convince the judges that the patent office did not have “substantial evidence” for its support of Broad Institute.
CRISPR’s scientific breakthrough — with the potential to cure countless genetic disorders from sickle cell anemia to cystic fibrosis — was devised by UC Berkeley cell biologist Jennifer Doudna and her European collaborator Emmanuelle Charpentier. It was improved upon by Broad Institute’s Feng Zhang.
“We presented compelling arguments today that the PTAB (U.S. Patent Trial and Appeal
Board Patent Office) committed several legal errors, including disregarding Supreme Court and Federal Circuit precedent,” Charles F. Robinson, UC general counsel said in a statement after Monday’s 35-minute hearing.
“Based on the questioning today, we are optimistic that the court has serious doubts about several aspects of the PTAB’s decision,” he said.
Broad also declared victory. “Based on the oral arguments today, we are even more confident the Federal Circuit will affirm the PTAB’s judgment,” the institute wrote in a statement.
A decision is expected by late summer.
The CRISPR gene-editing tool gives scientists near godlike power: moving genes from one living creature to another. In a mere five years, it has transformed research into plant and animal breeding, treatment for hereditary disease and strategies for combating infectious disease and cancer.
UC asserts that patents issued to the Broad Institute interfere with a patent application filed six months earlier by Doudna and Charpentier, who is now at the Max Planck Institute.
The Patent Trial and Appeal Board in 2017 ruled that Broad’s patents for CRISPR are sufficiently different from patents applied for by UC, and that they can stand.
It agreed with Broad’s assertion that its patents specified how CRISPR could be adapted for use in eukaryotic cells — that is, complex cells that include animal, plants, and humans — and Berkeley’s didn’t.
So Broad’s patents don’t interfere with the granting of Berkeley’s patents, and should be allowed to stand, the board said.
At Monday’s hearing, UC’s lead attorney Donald B. Verrilli Jr., partner at Munger Tolles & Olson LLP and former U.S. solicitor general, spent much of his time arguing that Broad’s work was simply an extension of UC’s and thus not deserving of patents, according to STAT, an online journalism site about life sciences and medicine. UC scientists showed that it worked on DNA in a test tube, using conventional techniques — so it wasn’t much of a stretch for Broad to get it to work in mammalian cells, Verrilli said.
“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,” said Verrilli.
Does UC have a shot? Not much of one, said patent experts consulted by STAT.
The university clearly failed to win over at least one of the three judges and, at best, did not lose too much ground with a second, said STAT. The third judge asked almost no questions and so did not tip his hand.
Judge Kimberly Moore, in particular, seemed unconvinced by the arguments made by Verrilli, according to STAT.
“That’s how science works, Mr. Verrilli,” she retorted. She added: “It’s hard for me to say there wasn’t substantial evidence” to back up the patent office’s ruling against UC.
Patent attorney Michael Stramiello of Paul Hastings, who attended the arguments, told STAT: “UC came into this argument from a tough spot, and I doubt that oral arguments from either side moved the needle much.”
The 2017 ruling has cast a pall over the university’s future earnings from a transformative technique.
It limits UC’s use of the system to bacteria, not plants, animals and humans. Patents are most valuable if they’re useful in human medicine.
That ruling is at odds with how UC and much of the science world view their work, which is that UC’s invention in bacteria was necessary for others, like Broad, to apply it to animals, plants and humans, says UC.
The global scientific community has widely recognized Doudna and Charpentier as inventors of CRISPR-Cas9 in any cell or environment, awarding such prestigious awards as the $450,000 Japan Prize, the $3 million Breakthrough Prize, the $500,000 Gruber Foundation Prize in Genetics, and others.