Cal denied exclusive patent rights to gene editing tool
Court says university does not have exclusive rights to patents
A federal appeals court has rejected arguments that UC Berkeley has exclusive rights to patents for the powerful CRISPR gene editing tool, casting a pall over the university’s future earnings from a technique which gives scientists near godlike power: altering the genetic sequences of cells.
On Monday, the U.S. Court of Appeals for the Federal Circuit in Washington upheld an earlier ruling that patents held for inventions by the Harvard University-affiliated Broad Institute were different from what’s covered by UC’s applications, and do not interfere with each other.
The transformative technique was devised by UC Berkeley cell biologist Jennifer Doudna, but improved upon by Feng Zhang of the Broad Institute.
It means that Broad can keep its patents and continue to share the technology with many licensees, most notably Editas Medicine of Cambridge, MA.
In response, “we are evaluating further litigation options,” said Charles F. Robinson of UC’s Office of the President, suggesting an appeal to the U.S. Supreme Court or the full U.S. Court of Appeals for the Federal Circuit.
“It is time for all institutions to move beyond litigation,” Broad Institute said in an official statement. “We should work together to ensure wide, open access to this transformative technology.”
UC contested a dozen CRISPR-based patents held by Broad, saying that their discoveries overlapped. The university has spent millions of dollars on the fight, a cost reimbursed by Berkeley-based biotech startup Caribou Biosciences, which has licensed the tool.
But the Broad Institute disagreed — and fought to retain its valuable patents.
Last April, the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office sided with Broad, ruling there is “no interference in fact” — meaning that the universities’ discoveries accomplish different things. The use of CRISPR in plant and animal cells is separately patentable, it concluded.
UC has scored smaller but still significant victories in the multi-fronted war for rights to CRISPRCas9 technologies. It has earned a patent covering the use of editing short genome regions of 10 to 15 nucleotides long. Nucleotides are the 3 billion letters that write the genome’s book of life. It also holds a patent to edit genetic material called single-stranded RNA.
CRISPR, or Clustered Regularly Interspaced Short Palindromic Repeats, allows scientists to identify any gene sequence in any cell and cut it out — and sometimes even repair it.
In mid-2012, while studying the inner workings of bacteria, UC’s Doudna and Emmanuelle Charpentier, now at the Max Planck Institute for Infection Biology, created a way to use CRISPR in simple cells.
Six months later, Zhang published research showing that it could be used inside plant and animal cells, including humans.
Also on Monday, the Gladstone Institutes announced that Doudna will open a laboratory on its San Francisco campus, where she will lead new collaborations that will help apply this breakthrough technique to human disease — a new field of medicine dubbed “genome surgery,” which cuts out or modifies harmful genes.
Monday’s decision, according to the bioscience journal STAT, turned on two key and related points: whether Broad’s work in mammalian cells was “obvious” in light of Doudna’s work in bacteria, and whether Broad had a “reasonable expectation of success.”
UC sought to have Broad’s patents canceled, arguing that researchers simply used “conventional off-the-shelf tools” to employ Berkeley’s innovation.
In its continued fight, said UC’s Robinson, “we look forward to proving that Drs. Doudna and Charpentier first invented usage in plant and animal cells — a fact that is already widely recognized by the global scientific community — as the Doudna-Charpentier team’s several pending patent applications that cover use of CRISPR-Cas9 in plant and animal cells are now under examination by the patent office.”