UC Berkeley wins chance to reclaim lucrative gene editing patent
With potentially huge sums at stake, a federal court on Monday reinstated UC Berkeley's legal claim seeking nationwide rights to develop and market gene editing, the transfer of genetic technology between living organisms with the capability of curing diseases.
The U.S. Patent Trial and Appeal Board ruled in 2022 that the patent for so-called CRISPR technology belonged to the Broad Institute, affiliated with Harvard and the Massachusetts Institute of Technology, which had published a study in 2012 describing how the technology could be used to alter genes in plants and animals.
The board rejected a competing claim from the University of California, whose scientists had reported on the use of CRISPR technology to alter DNA six months before the Broad study. The patent board said the UC Berkeley report was the first of its kind but did not apply directly to genes in plants and animals.
But the U.S. Court of Appeals for the Federal Circuit ruled Monday that UC had presented evidence that its findings could be developed and applied to genes in all living creatures.
The patent board cited the UC scientists' 'experimental difficulties and … statements of doubt' about the application of their newly discovered technology, but failed to consider evidence that 'routine methods or skill' could enable the scientists to clear those hurdles and show that they were the original source of the information, Judge Jimmie Reyna wrote in the 3-0 ruling.
The court ordered the patent board to reconsider UC's contention that its study was the original breakthrough.
'This could end up being a big windfall for the University of California,' said Jacob Sherkow, a professor of law and medicine at the University of Illinois who has followed the issue for more than a decade.
He said the Broad Institute was paid $400 million in one of its first contracts with companies seeking to license the CRISPR technology. That contract and others already signed are not at risk, Sherkow said, but if Broad loses the patent, 'no one will sign a future license with them.'
Jeff Lamken, an attorney for UC in the case, said the ruling would enable the patent board to 're-evaluate the evidence under the correct legal standard and confirm what the rest of the world has recognized: that the (UC scientists) were the first to develop this groundbreaking technology for the world to share.'
The Broad Institute said in a statement that it was 'confident' the patent board 'will reach the same conclusion and will again confirm Broad's patents, because the underlying facts have not changed.'
The UC team was led by biochemist Jennifer Doudna and also included French scientist Emmanuelle Charpentier. In 2020, those two won the Nobel Prize in chemistry for their research on CRISPR, the first time two or more women had won that prize without a male partner.
In its 2022 ruling, the patent board cited Doudna's statement that the UC study had one shortcoming: 'We weren't sure if (the technology) would work in eukaryotes,' the cells found in plants and animals. The board noted that the scientists had experienced several failures in experiments with fish and human cells, and concluded that – unlike the Broad Institute study six months later – UC's report was 'not yet a definite and permanent reflection of the complete invention as it (would) be used in practice.'
But the appeals court said the patent board should have allowed UC to show that its scientists had made the crucial findings in their 2012 report and could take the final steps by using ordinary scientific methods and skills.
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