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11 September 2018Americas

Federal Circuit sides with Broad Institute in CRISPR clash

The US Court of Appeals for the Federal Circuit handed a win to the Broad Institute of Harvard and MIT yesterday, after finding that the research institute is entitled to some patents covering CRISPR technology.

In a precedential decision, the Federal Circuit affirmed the validity of the patents and rejected a challenge brought by researchers at the University of California (UC), Berkeley and the University of Vienna.

UC Berkeley had requested an interference proceeding, claiming that the claims of 12 patents and one application owned by the Broad Institute interfered with its own application.

In the proceeding, the Broad Institute requested priority based on its patent application filed on December 12, 2012. UC Berkeley, which filed applications on May 25, 2012 as well as in 2013 and 2014, similarly asked for its applications to be prioritised.

Last February, the Patent Trial and Appeal Board (PTAB) held that the Broad Institute’s patents—which are all limited to CRISPR/Cas9 systems in a eukaryotic environment—do not interfere with patent claims (which are not restricted to any environment) filed by UC Berkeley and the University of Vienna.

“Broad has persuaded us that the parties claim patentably distinct subject matter, rebutting the presumption created by declaration of this interference,” said the PTAB.

However, UC Berkeley and the University of Vienna appealed against the decision to the Federal Circuit in July 2017, asking the court to determine whether the PTAB committed error in “ignoring overwhelming evidence” that the Broad Institute’s claims are obvious in light of UC Berkeley’s.

Three months later, the Broad Institute responded, arguing that the PTAB’s ruling was supported by substantial factual evidence, that it was fully consistent with the law, and that it considered the evidence presented in the case.

Yesterday, the Federal Circuit agreed with the Broad Institute, concluding that the PTAB’s factual findings are supported by substantial evidence and that the board didn’t err in holding that the Broad Institute’s claims wouldn’t have been obvious.

The PTAB had found that a person of ordinary skill in the art wouldn’t have had a reasonable expectation of success in applying the CRISPR/Cas9 system in a eukaryotic cell.

“In light of the record evidence, which includes expert testimony, contemporaneous statements made by skilled artisans, statements by the UC inventors themselves, and prior art failures, we conclude that the board’s factfinding as to a lack of reasonable expectation of success is supported by substantial evidence,” said the Federal Circuit.

UC Berkeley contended that the board was wrong to dismiss evidence of simultaneous invention as irrelevant, adding that simultaneous invention can be compelling evidence of obviousness.

The Federal Circuit said that it has previously recognised that simultaneous invention may have a bearing on the obviousness analysis and that the PTAB recognised the evidence as being relevant.

“We consider Broad’s evidence of simultaneous invention, along with evidence regarding the state of the art, the statements of the inventors, failures involving similar technologies, and the remainder of the record evidence, and conclude the Board’s finding is supported by substantial evidence,” said Circuit Judge Kimberly Moore on behalf of the court.

Responding to the ruling, the Broad Institute said the Federal Circuit made the correct decision.

The institute added: “It is time for all institutions to move beyond litigation. We should work together to ensure wide, open access to this transformative technology.”

UC Berkeley said it is evaluating further litigation options.

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More on this story

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23 July 2019   Merck KGaA-owned Sigma-Aldrich has petitioned the US Patent and Trademark Office to open an interference proceeding between its own pending CRISPR-Cas9 patents and patents awarded to the University of California, Berkeley.
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27 June 2019   The US Patent and Trademark Office has revived the dispute between the Broad Institute of MIT and Harvard and the University of California, Berkeley over which first invented the CRISPR gene-editing technology.
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13 March 2019   Press releases in recent months that suggest the CRISPR IP saga is about to end are too optimistic and miss out many of the nuances of the current situation, according to Claire Irvine, partner at HGF.

More on this story

Americas
23 July 2019   Merck KGaA-owned Sigma-Aldrich has petitioned the US Patent and Trademark Office to open an interference proceeding between its own pending CRISPR-Cas9 patents and patents awarded to the University of California, Berkeley.
Americas
27 June 2019   The US Patent and Trademark Office has revived the dispute between the Broad Institute of MIT and Harvard and the University of California, Berkeley over which first invented the CRISPR gene-editing technology.
Americas
13 March 2019   Press releases in recent months that suggest the CRISPR IP saga is about to end are too optimistic and miss out many of the nuances of the current situation, according to Claire Irvine, partner at HGF.