A researcher with the Broad Institute published a study in 2012 describing how the so-called CRISPR technology could be used to alter genes in humans, other animals and plants. The U.S. Patent and Trademark Office granted a patent to Broad in 2014, but it was challenged by the University of California, which contended the work was not original. Six months before Broad's study, a team of scientists led by UC Berkeley biochemist Jennifer Doudna had issued the first report on the use of CRISPR to alter DNA.
On Monday, however, the U.S. Patent Trial and Appeal Board said Broad's research had been original and its patent was valid. Although the Berkeley study was the first to uncover technology that could transform genetic material, the board said, it involved DNA in bacteria and had no direct application to genes in plants and animals, whose cells are classified as "eukaryotes."
Doudna and co-researcher Emmanuelle Charpentier of France won the Nobel Prize in chemistry in 2020 for their ground-breaking research on CRISPR — the first time two or more women had won the prize without a male partner. But the board noted that Doudna herself had reportedly said the UC study, though highly successful, had one shortcoming: "We weren't sure if CRISPR-Cas9 (the technology) would work in eukaryotes — plant and animal cells."
"The evidence shows that the invention of such systems in eukaryotic cells would not have been obvious over the invention of CRISPR-Cas9 systems in any environment," such as the one described by Berkeley-led researchers, the three-judge panel said. "One of ordinary skill in the art would not have reasonably expected a 11 CRISPR-Cas9 system to be successful in a eukaryotic environment."
The panel also cited another UC researcher who, after noting differences between the Cas-9 system and genetic material that worked on plants and animals, said Cas-9 might be tried on eukaryotic cells but there was "no guarantee" that it would work.
"We fail to see how 'no guarantee' indicates an expectation of success," the standard required by law, the panel said.
Therefore, the patent board said, Broad had not based its findings on UC Berkeley research, or on any information that would have been evident from that research, and was entitled to patent its own study.
In response, Broad said it has offered to work with researchers elsewhere on "a joint licensing strategy, or patent pools," and would continue to do so.
"All institutions should work together to ensure wide, open access to this transformative technology," the institute said in a statement. "Broad believes CRISPR technology should be available to the global scientific community to advance our understanding of the biology and treatment of human disease, and to help lay the groundwork for a new generation of therapies."
UC Berkeley said it believes the patent board "made a number of errors" and it was considering possible challenges to the ruling. It could appeal to the U.S. Court of Appeals for the Federal Circuit, which ruled against the university at an earlier phase of the case in 2018.
UC also said it has obtained more than 40 separate patents based on its gene research, and that the Broad Institute's patent is being challenged separately by other claimants. Meanwhile, the university said, Doudna and Charpentier "have each continued to lead the global development and ethical application of CRISPR technology."
©2022 the San Francisco Chronicle. Distributed by Tribune Content Agency, LLC.
