A surprise ruling last week reignited the high-profile patent fight over who invented a key application of the genome editor CRISPR. The 3-year-old battle pits parties represented by the University of California (UC) against the Broad Institute in Cambridge, Massachusetts. It revolves around the use of CRISPR, originally derived from a DNA-cutting system used by bacteria, in the more complex cells of eukaryotes—including humans, which means the outcome could shape the development of potentially lucrative CRISPR-based medical treatments.

Triggered by new patent claims from the UC group, the development resurrects contentious debates that calmed down after a court decision in September 2018 favoring the Broad Institute. The UC team, which represents Jennifer Doudna from UC Berkeley and her collaborators, had first published the use of CRISPR as a genome-editing tool in Science in June 2012, but they did not demonstrate that it worked in eukaryotes.

In January 2013, Broad’s team, led by Feng Zhang, published a paper—also in Science—that described its success in mouse and human cells. After the U.S. Patent and Trademark Office awarded Broad several patents, UC requested what’s known as an interference, contesting Broad’s patents based on its own submitted patent. UC’s attorneys argued that after the Doudna group’s 2012 paper, it was “obvious” that CRISPR would work in eukaryotes.

The Patent Trial and Appeal Board (PTAB) ruled against UC in February 2017, and the U.S. Court of Appeals for the Federal Circuit denied UC’s appeal 1 year later. In April 2018, however, UC filed new patent claims that highlighted its invention’s utility in eukaryotic cells, prompting PTAB to rule that the two parties’ claims now create an interference issue that needs to be examined in a hearing.

Eldora Ellison, a lead attorney for the UC team—who works at Sterne, Kessler, Goldstein & Fox in Washington, D.C., says PTAB ruled in 2017 that there was no interference because Broad focused on eukaryotes and the UC patent made claims about the utility of CRISPR in “any environment.” “What they said is, ‘We’re actually not going to have a fight at this point in time, because we think that these are two different inventions,’” Ellison says. “They kind of kicked the can down the road on who was first to invent the use of CRISPR in eukaryotes.”

Now that UC has sharpened its claim to the use of CRISPR in eukaryotes, Broad “[looks] forward to participating in the interference process,” according to a statement from the institute. Broad argues the new interference “challenges the validity of [UC’s] eukaryotic claims.” The ruling deems the Broad group the “senior party,” which means UC “carries the burden of proof” and must convince PTAB that the Broad team did not invent the eukaryotic use of CRISPR.

Catherine Coombes, a patent attorney at HGF in York, U.K., who does not represent Broad or UC but is involved in CRISPR patent disputes, says the new interference “adds to the complexity of the landscape.” The European Patent Office has granted what’s known as “overlapping rights” to both groups and others who have filed CRISPR patent applications, Coombes says—a temporary resolution in anticipation of future legal fights. “For human therapeutics, it is still too early to know where the key patents will lie,” she adds, noting that CRISPR systems vary, using different enzymes that ultimately may make one version safer or more effective than another.

The patent uncertainty created by the new interference declaration may prod UC and Broad to cut a deal, Coombes says. Broad says in a separate statement that it has long hoped UC would enter a “patent pool,” which effectively would allow both parties to earn money from their inventions without becoming ensnarled in legal wrangling.

The parties will discuss the interference with PTAB in a conference call on 5 August. If they do not reach a settlement, the interference hearing is expected in about 8 months.



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