The legal battle-royal over who invented CRISPR will move into a new and likely protracted phase after the U.S. Patent and Trademark Office (USPTO) this week said it will launch an “interference” proceeding aimed at resolving the impasse.
At issue is a pending patent application listing as inventors Jennifer Doudna, Ph.D., of the University of California, Berkeley, and Emmanuelle Charpentier, Ph.D., of the Helmholtz Centre for Infection Research. The inventors are challenging the awarding of 12 patents related to the technology that list as inventor Feng Zhang, Ph.D., of the Broad Institute of MIT and Harvard. Some of the 12 list additional colleagues as inventors.
Administrative Patent Judge Deborah Katz declared the interference on Monday, referring the dispute to the three-member Board of Patent Appeals and Interferences. The board is scheduled to hold a telephone conference call among the parties on March 9.
In the interference, which will be managed by Judge Katz, the board will gather and weigh evidence with the goal of establishing dates of invention. Patent rights will be conferred based on who was first to invent, since the applications in question were filed before the Leahy-Smith America Invents Act took effect, shifting the U.S. to a “first-to-file” patent system.
USPTO named the University of California (UC) as the senior party, and the Broad Institute as junior party. The designations will require the Broad to show that Dr. Zhang and colleagues were first to invent CRISPR, notwithstanding the agency awarding the technology’s first patent (No. 8,697,359) to the institute in April 2014 for “systems, methods, and compositions for altering expression of target gene sequences and related gene products.”
“A lot of this is going to come down to not just the filing date, it’s what in the documents on the filing date,” Lisa Haile, J.D., Ph.D., a partner at the law firm DLA Piper, told GEN. “I don’t think this is going to be finally decided for a couple of years.”
It remains to be seen whether the dispute will slow down the rush by investors and startups formed to commercialize CRISPR technology. One such startup is Editas Medicine (co-founded by Drs. Zhang and Doudna, who is no longer part of the company), which raised $120 million in August and $43 million in 2013.
Another startup, Intellia Therapeutics (where Dr. Doudna is a founding member and scientific advisor), raised $70 million in September, attracted Novartis as a collaboration partner (with undisclosed equity holding) in January 2015, and won $15 million in 2014. Yet another company, Caribou Biosciences (where Dr. Doudna is a co-founder and investor), raised $11 million in April followed by an undisclosed equity investment by DuPont in October.
Anecdotally, Dr. Haile said the dispute has made one client more comfortable about CRISPR: “They know that there’s not going to be any decision for the next two or three years, so they’re proceeding because it’s not clear who to take a license from.
“If there’s uncertainty over who owns it and who to get a license from, what do you do? You keep working away,” Dr. Haile said. “I think the technology may even move faster.”
In the end, the parties could end the interference by agreeing to settle the dispute, as happened in 2011 with RNA interference (RNAi) technology. As senior partner, UC is responsible for initiating settlement discussions between the parties.
“This is such an important technology for the industry I just almost think that for the sake of the industry, settlement between the parties would make sense,” Dr. Haile added.