It’s baaaaack, that reputation-shredding, stock-moving fight to the death over key CRISPR patents. On Monday morning in Washington, D.C., the U.S. Court of Appeals for the Federal Circuit will hear oral arguments in University of California v. Broad Institute. Questions?
How did we get here? The patent office ruled in February 2017 that the Broad’s 2014 CRISPR patent on using CRISPR-Cas9 to edit genomes, based on discoveriesby Feng Zhang, did not “interfere” with a patent application by UC based on the work of UC Berkeley’s Jennifer Doudna. In plain English, that meant the Broad’s patent, on using CRISPR-Cas9 to edit genomes in eukaryotic cells (all animals and plants, but not bacteria), was different from UC’s, which described Doudna’s experiments using CRISPR-Cas9 to edit DNA in a test tube—and it was therefore valid. The Patent Trial and Appeal Board concluded that when Zhang got CRISPR-Cas9 to work in human and mouse cells in 2012, it was not an obvious extension of Doudna’s earlier research, and that he had no “reasonable expectation of success.” UC appealed, and here we are.
What’s the morning line? UC has its back to the wall. As in an appeal of a criminal case, this appeal is all about the law and whether the patent office interpreted and applied it correctly; there won’t be any dramatic new evidence. UC’s lawyers “won’t whip out a document and say aha!” said biotech patent attorney Kevin Noonan of McDonnell Boehnen Hulbert & Berghoff. Instead, UC will have to persuade the judges that the patent board ignored evidence, that its decision was not based on what a reasonable person would consider “substantial evidence,” or that it misapplied the law on obviousness or expectation of success.
Why are “obvious” and “expected to succeed” so important?Because PTAB’s conclusion that Zhang’s CRISPR invention was neither obvious nor a sure thing sealed the win for the Broad. The best line of attack for UC will therefore be that the patent board misinterpreted case law on the meaning of “obvious” and “reasonable expectation of success,” said intellectual property expert Jacob Sherkow of New York Law School. PTAB leaned heavily on Doudna’s own words about how hard it would be to make CRISPR work in human cells. UC might cite case law to argue that her comments (which are very typical for cautious scientists) shouldn’t count, and that PTAB’s ruling that the Broad’s patent is valid “was therefore predicated on an erroneous conclusion of law,” Sherkow said. UC’s best chance of success is to persuade at least two of the three judges that the patent board misapplied case law in its application of the “obviousness” idea in a way “that was too generous to the Broad,” said patent expert Dmitry Karshtedt of the George Washington University Law School.
Does UC have a shot? Not much of one, said the experts consulted by STAT. Persuading the appeals court that the patent board messed up on the law “is an incredibly tough barrier for them to break through,” Sherkow said. Noonan said UC “has some heavy lifting to do,” especially since a Supreme Court decision said “the federal circuit has to give deference to the factual determinations” of a panel like PTAB. According to GWU’s Karshtedt, “Given that the PTAB decision was lengthy and seems well-reasoned, deference seems likely.”
Does UC have any reasons for optimism? UC ditched its previous legal team and went full-on nuclear, legal-firepower-wise, by hiring Donald Verrilli. As solicitor general under President Obama, Verrilli saved Obamacare not once but twice before the Supreme Court, won the marriage equality case there, and got SCOTUS to invalidate patents on human genes. In other words, the guy has won tough cases before. He’ll be arguing against Raymond Nimrod of Quinn Emanuel for the Broad. Each gets 15 minutes, including answering judges’ questions.
When will I know if I need to short Editas Medicine or Intellia Therapeutics? When you know which three judges are hearing the case. No one knows which three (of 18 on the court) it is until they stride into Courtroom 201 at 10 a.m. EDT. If one is Judge Raymond Chen, the Broad likely has one sure vote: He worked at the patent office for 15 years and is regarded as deferential to it—that is, unlikely to overturn its pro-Broad decision. Advantage: Editas (EDIT), co-founded by Zhang and exclusive licensee of the Broad’s patents for human therapeutic use. If it’s judges Alan Lourie, who spent decades as a corporate patent lawyer, or Timothy Dyk, also an ex-corporate guy and patent expert, that might be good for UC and therefore Intellia (NTLA), co-founded by Doudna and exclusive licensee of her (yet-to-be-issued) CRISPR patents. The judges’ questions can offer clues to how they’re leaning. (Since the court requires observers to turn off all electronics, STAT won’t be live-tweeting the proceedings, but check our home page on Monday for the recap.)
When will we have a decision? In as little as a week if the judges regard the case as meh, with no need to establish precedent and therefore write a long, complicated opinion. But that seems very unlikely. “This is an important, high-profile case,” said Karshtedt, who therefore expects a thorough, lengthy opinion. That probably mens in 60 to 90 days.
And then it’s over, right? The losing side will have at least 60 days to appeal to the Supreme Court, which would decide sometime after October whether or not to take the case. Betting? “The Supreme Court won’t touch this,” Noonan said. Maybe then we’ll have serious settlement talks.