A special board of the US Patent and Trademark Office has reignited the long-running patent fight over who invented the groundbreaking CRISPR-Cas9 gene editing system.
Nearly a year ago, the matter seemed put to rest after a federal court upheld a ruling of the same patent office board. The court validated a key 2014 patent issued to the Broad Institute in Cambridge, MA, because it did not compete—or in PTO-speak, “interfere”—with work by rival scientists at the University of California, Berkeley, and two European universities that was published in their seminal 2012 paper.
According to last year’s ruling, Broad researchers led by Feng Zhang showed how to edit the DNA of a eukaryotic cell—that is, anything belonging to an animal, plant, algae, or fungus. The Berkeley group, led by Jennifer Doudna and Emmanuelle Charpentier, did not specify a type of cell in their seminal work published in 2012.
But the ruling left unanswered an important question: Who invented CRISPR-Cas9 editing in eukaryotic cells? The question could have financial and strategic ramifications for biotech companies using CRISPR to develop medicines and other products. Various firms have aligned themselves with one of the two sides. For example, Editas Medicine (NASDAQ: EDIT) and Beam Therapeutics are key licensees of the Broad. Intellia Therapeutics (NASDAQ: NTLA) and CRISPR Therapeutics (NASDAQ: CRSP) are tied to the Berkeley camp via a research company that Doudna founded earlier this decade.
CRISPR Therapeutics became the first known firm to put an experimental CRISPR medicine into humans this year, in a study to treat the blood disease beta-thalassemia.
Regardless of who eventually can claim invention of CRISPR-Cas9, the skills to use it unhindered have spread around the world. Its use has taken a much darker turn, as well. Last fall, a Chinese scientist revealed that he edited the DNA of the embryos of twin girls with the goal of giving them immunity to HIV infection. His claim was met with charges of recklessness and fear that he has done more harm than good to the girls. More recently, a molecular biologist in Russia revealed his plans to implant gene-edited embryos in women in an experiment that targets the same gene that the Chinese scientist did.
The special board, known as the Patent Trial and Appeal Board, today declared an interference between the two sides. In other words, there’s enough overlapping material in the various patents and applications that the PTO wants to sort it out.
In a statement issued by UC Berkeley, its outside patent counsel Eldora Ellison said, “We are confident that the USPTO will ultimately recognize that the Doudna and Charpentier team hold the priority of invention specific to eukaryotic cells, as well as other settings covered by previous patents.”
A statement released by the Broad Institute said the new interference, triggered by the patent office, “challenges the validity of UCB’s eukaryotic claims,” with the burden of proof resting on the Berkeley side.
In an interview, Ellison challenged that notion. The two sides will be arguing over many things in the first phase of the interference process, including the PTO’s choice of material from each party that is relevant to the case. (Somewhat akin to lawyers in a criminal trial asking the judge to dismiss evidence.) The party required to show burden of proof, said Ellison, can “flip flop” after the first phase.
The two sides and the judge are first scheduled to talk on Aug. 5. The first part of the process could take eight months, according to PTO documents.