gavel patent CRISPR

Joe Gratz

The US Patent and Trademark Office has upheld a series of patents covering CRISPR/Cas9 gene editing granted to the Broad Institute of MIT and Harvard, dealing a substantial blow to attempts by the University of California Berkeley to overturn those patents. 

This decision could mark the conclusion of a bitter battle for supremacy between the two organisations, over the intellectual property rights to the technology. The market for CRISPR is projected to be worth more than $5.5 billion by 2021, fuelling a frantic race to capitalise on the potentially lucrative technology.

Lawyers for UC Berkeley filed for an “interference” proceeding, arguing that although the Broad was awarded it’s CRISPR patents first, the University was the first to apply for a patent on the technology. During oral arguments presented to the USPTO in December, the arguments from both sides boiled down to two key points: “obviousness” and “reasonable expectation of success”.

Jennifer Doudna of UC Berkeley was the first to develop and publish on the key components of the CRISPR system and demonstrate that it could edit DNA in prokaryotes. The University contend that making the move from prokaryotes to eukaryotes is “obvious”, and as a result the Broad patents, awarded to Feng Zhang in 2014 for his work in eukaryotic cells, conflicts with their existing patent. The Broad countered by stating that there was no “reasonable expectation of success” by people who are skilled in genome editing, arguing that Doudna herself “experienced ‘many frustrations’ getting CRISPR to work in human cells.” 

On February 15, patent judges for the USPTO ruled that there was “no interference in fact”, meaning that the CRISPR patents awarded to the Broad are sufficiently different to those applied for by UC. The judges explain in a 51-page decision that the Broad had convinced tham “that the parties claim patentably distinct subject matter.”

Arguably this ruling creates greater uncertainty for the CRISPR commercial landscape than before. Although the Broad have dodged interference with UC’s patents, according to Kevin Noonan, a partner at the firm McDonnell Boehnen Hulbert & Berghoff in Chicago, Illinois, this does not simplify the situation for companies looking to license the technology.

“Everybody gets to keep their patents,” he explains. “This is maximum uncertainty for people because you don’t know if you have to get licenses from both sides.” The University’s patent application will be referred back to an examiner, but there is a strong possibility that legal challenges will continue.

Officials at UC have said that in spite of the ruling their patent would nevertheless cover the use of CRISPR/Cas9 in all cells, both eukaryotic and prokaryotic. Jennifer Doudna likened the decision to someone wanting to use green tennis balls. “They will have the patent on the green tennis balls,” she said, in reference to the Broad patents. “We will have the patent on all tennis balls.”

In spite of this stance, stock in gene-editing startup Editas Medicine, which has licensed the use of CRISPR from the Broad Institute, soared in the wake of the ruling. “We are pleased with the USPTO’s decision,” said Editas president Katrine Bosley in a statement. “This important decision affirms the inventiveness of the Broad’s work.”

 

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