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Biotech 'trial of the century' could determine who owns CRISPR

NORTHERN CALIFORNIA RECORD

Sunday, December 22, 2024

Biotech 'trial of the century' could determine who owns CRISPR

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ALEXANDRIA, Va. -- The U.S. Patent and Trademark Office in Virginia heard arguments Dec. 6 from the University of California, Berkeley and the Broad Institute of MIT and Harvard regarding the ownership of the CRISPR gene editing method. 

The parties are in dispute over the gene patent as it has not been said who exactly developed the product. Although UC Berkeley was the first to file a patent application, the Broad Institute has won many honors regarding its research on the method. All three universities have worked together on the method previous to the ruling. 

Michael Cohen of Cohen IP Law Group told the Northern California Record, "This is a fascinatingly complex and rare type of case. Both parties have filed with the Board of Patent Appeals and Interference hundreds of documents and exhibits. One of the main questions is whether Berkeley's disclosed invention/original patent filing easily translates bacteria to eukaryote cells.

"If that is the case, then the invention was disclosed in the Berkeley patent, and Broad/Zhang patents would be in jeopardy."

Berkeley argues it was the first to research and develop the patent. In fact. its own employees, Jennifer Doudna and Emmanuel Charpentier, were the first to perform work on it.

However, Cohen noted, "Doudna stated in a 2012 interview that she wasn't sure if the invention would work in eukaryotic cells and that she had 'frustrations' getting CRISPR to work in human cells. That fact helps bolster Broad/Zhang's position that it was NOT obvious to take a pathway from prokarotes/bacteria and utilize it in eukaryotic cells."

There is a possibly the parties involved could share a patent on the gene editing method. Cohen said,  adding. There can be a number of different outcomes."

"One possibility is that the board can rule that each respective party is entitled to certain applications of the invention," he said. "Or if, prior to the board reaching a decision, the parties can reach a settlement of some sort but that seems unlikely given that the interference already took place."

Milord Keshishian, attorney at Milord and Associates PC, told the Northern California Record, "Because of the potential magnitude of this invention, a settlement is highly unlikely. In fact, from the PTAB’s records (entry 576, ), the parties’ July 2016 settlement discussions were unfruitful."

Keshishian also said this case could affect all universities and schools involved.

"If the three-judge panel rules in favor of the MIT group, the interference will be terminated," he said. "An alternative ruling for the UC Berkeley group means the proceedings will continue to determine the owner of the invention. To the victor will go the licensing revenue spoils, which could be billions of dollars."

Both Cohen and Keshishian expect the case to be heard again in early spring 2017. Keshishian added,  "There will be no 'final decision' until the appellate court routes are exhausted, which could be many years down the road."

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