Here We Go Again: Feds Reopen Patent Dispute Between UC and Broad Institute

The U.S. patent office has declared an interference between a dozen key patents awarded to the Broad Institute on the genome-editing technology CRISPR and 10 CRISPR patent applications submitted by the University of California and its partners, according to documents posted by the U.S. Patent and Trademark Office.

The declaration of an interference means that the patent office has determined that one or more patent applications describe inventions that are substantially the same as those for which patents have already been issued. In this case, the patents awarded to the Broad, beginning in 2014, describe the use of CRISPR-Cas9 to edit the genomes of eukaryotes — organisms whose genomes are enclosed within a cell nucleus, including all plants and animals — based on the research of Broad biologist Feng Zhang. UC’s patent applications also cover the use of CRISPR in eukaryotes, based on the work of UC Berkeley biochemist Jennifer Doudna and her collaborator Emmanuelle Charpentier.

UC and the Broad already went through an interference proceeding that went all the way to federal appeals court, with the Broad prevailing.

That history made patent experts react almost identically to this latest development. “Here we are again,” said attorney Kevin Noonan of the Chicago law firm McDonnell Boehnen Hulbert & Berghoff LLP, who specializes in biotech patents. “I can only imagine that this will go on, and on, and on.”

Both the Doudna and Zhang teams did their research under a system that awarded patents based on who was the first to invent (the current system, in place since 2013, awards patents based on who was the first to file). The interference proceeding will entail motions filed with the patent office, which will likely take a year, and then possibly a hearing. At some point, the patent office will therefore have to determine who was the inventor of CRISPR genome editing in higher organisms — not bacteria, and not DNA floating freely in a test tube.

“Now we’re having the fight over who invented CRISPR in eukaryotes,” said Eldora Ellison of Sterne Kessler Goldstein & Fox, who represents UC. The declaration of interference, she said, “means that the patent office has recognized that it has a duty to determine who invented this important invention. The fact that the Broad has patents does not resolve that question.”

The answer to that question would reverberate well beyond the potentially billion-dollar market for CRISPR therapies. Those are being developed by at least three companies, including Editas Medicine, CRISPR Therapeutics, and Intellia Therapeutics. The outcome could also affect who the science record books, to say nothing of the Nobel Prize committee, recognizes as the inventors of this revolutionary technology.

In a statement, the Broad said, “We welcome this action by the [patent office], which has previously ruled that the claims of the Broad patents, issued for methods for eukaryotic genome editing, were properly granted.”

Unlike the last interference, which UC requested, neither party asked for this one. But that can be done “indirectly,” Noonan said.

“The interesting thing in terms of the [University of California] strategy is that they seem to have filed a bunch of patent applications intended to provoke an interference,” by describing the use of CRISPR in eukaryotes even though the UC team was not the first to achieve that, Noonan said.

“If you write the [patent] claim the right way, and the patent examiner is aware that the Broad’s patents [on that invention] exist, it wouldn’t take a genius examiner to say, aha,” he said.

The patent office has designated the Broad as the “senior party” in the interference and UC as the “junior party.” That means the Broad, with patents in hand since 2014, is presumed to be the rightful, first inventor. UC therefore has to prove its case to the patent office.

This story was originally published by STAT, an online publication of Boston Globe Media that covers health, medicine, and scientific discovery.