Adversaries in the legal battle over the rights to the CRISPR gene-editing technology are preparing to fire their initial shots. In two documents filed with the U.S. Patent Trial and Appeal Board last week, lawyers for the Regents of the University of California (UC) and the Broad Institute (BI) in Cambridge, Massachusetts, offered hints at how they will lay claim to the breakthrough technology and its financial spoils. And UC lawyers have made accusations of error and deception that, if true, could invalidate BI’s patents early in the proceedings.
Much of the intellectual property around CRISPR’s simple and precise DNA-slicing mechanism was originally awarded to BI, for discoveries made by molecular biologist Feng Zhang. But UC claimed that its own still-pending patent applications, describing experiments by molecular biologist Jennifer Doudna of the UC’s Berkeley campus, in collaboration with microbiologist Emmanuelle Charpentier, now at the Max Planck Institute for Infection Biology in Berlin, should have received the patent protection instead. Their application was filed before BI’s, but because the BI group sought an expedited review process, it was awarded the key patents first.
UC’s official challenge to those patents, known as an interference proceeding, began in January. And on 3 March, both sides filed lists of proposed motions—requests for judgment on various aspects of the patent claims in dispute. The patent trial board judge still needs to approve these proposals before the motions can be officially filed or considered, but the documents offer initial clues to each side’s tactics, says Kevin Noonan, a biotechnology patent lawyer at McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, Illinois. “This is where you see the strategies on how to either end the interference early, or shape the interference to be in their favor.”
One of the proposed motions, if it pans out, could put an abrupt end to the proceedings, Noonan says. That argument, in the UC filing, hinges on provisions of the 2011 Leahy–Smith America Invents Act (AIA), a momentous change to U.S. patent law that put in place a “first to file” rather than a “first to invent” system. Once the law went into effect, on 16 March 2013, patent protection was determined by who filed a patent first, not who first made the discovery. But applicants filing after 16 March could still fall under the old rules (and compete with applications filed earlier) by asserting that the invention was made before the date of the changeover. That’s what BI did with its CRISPR patents, filed in 2013 and 2014, but claiming a so-called “priority date” of 12 December 2012.
UC claims that the BI patents don’t fall under the old system, because their filings indicate a mix of pre–16 March and post–16 March inventions. Because the filers checked a box indicating that some claims didn’t have this priority date, they can’t compete with Doudna’s patents in the first place, UC lawyers contend.
“I can’t imagine that [BI] would make this mistake, but it’s not impossible,” Noonan says, and if the accusation proves true, “that is Berkeley’s sort of clear-cut, slam-dunk winner.”
The UC filing contains a few other “bombshells,” notes law professor Jacob Sherkow of New York Law School in New York City, including an allegation that Zhang committed “inequitable conduct” by misrepresenting his discoveries in patent applications and laying claim to a technology he didn’t yet possess. The lawyers write that Zhang’s group claimed to have used tracrRNA—an RNA strand that helps to activate the DNA-cutting enzyme Cas9—but that he “never demonstrated in his supporting documents that he was in possession of any claimed methods that made use of tracrRNA.” BI “withheld or misrepresented material information with the intent to deceive” the patent office, UC’s filing claims. The document also claims that some of Zhang’s patent left off several co-inventors who apparently contributed to the work. That accusation could invalidate a patent, though it requires that UC show that the omission was the result of "deceptive intent," not just a mistake, Sherkow notes.
Lawyers for BI, meanwhile offered a list of claims within their patents that they say don’t correspond to anything in the UC patent applications, and therefore are not at risk of being overturned. They also suggest that some UC claims are invalid because they don’t properly describe how to use the technology—a requirement known as enablement.
Which of these motley strategies the two sides will be allowed to pursue depends on a 10 March conference call with the judge. In the months to follow, a decision on these motions could declare an early winner … or push the proceedings into a second phase, where researchers will offer evidence of who really made the inventions first.