Now this is going to be a complicated process indeed: the CRISPR patent dispute is now officially an interference proceeding at the USPTO. This was always a likely path – the main other one would have been for the parties involved to have negotiated some sort of cross-licensing agreement, but that doesn’t seem to be happening.
Even among patent attorneys—generally, friends of the arcane and hypertechnical—interference proceedings are famous for their complexity. The U.S. patent office now grants patents on a “first to file” basis. But before 2013 this was not the case. Historically, U.S. patent law instead recognized that patent rights should go to whoever could prove they were “first to invent” an idea. Because there is a lag between when patent applications are filed and when they are issued—roughly, three years—this gave rise to the possibility that a later inventor could be awarded a patent before the patent office had time to process an earlier inventor’s application. In that circumstance, the later inventor’s patent “interferes” with the earlier inventor’s ability to rightfully obtain theirs.
This is precisely what occurred between Doudna and Zhang, whose patents are covered by the older rule. Doudna, with colleagues in Europe, filed a provisional patent application on her early iteration of the CRISPR editing technology on May 25, 2012; Zhang did the same on December 12, 2012. But Zhang’s attorneys requested that the patent office expedite its review of his application under a procedure—funnily named a Petition to Make Special—that allows inventors a quick up-or-down vote on simplified patent applications. As a result, Zhang was awarded his first patent on April 15, 2014, while Doudna’s patent application remained in limbo. Shortly thereafter, Zhang was awarded over a dozen patents on various forms of the technology.
And this is but a tiny appetizer compared to the legal banquet to come. The original Doudna patent application did not specifically address gene editing in mammalian (human) cells, but that was amended pretty swiftly, and I suspect that one argument is going to be that the extension to such cells was felt to the “obvious to one skilled in the art”. And as that Technology Review article mentions, when the Doudna patent was being examined, a number of third parties popped up claiming (rightly or wrongly) that it was not the first example of the technology, anyway.
Interference proceedings work with a panel of three patent judges, and the amount of evidence they’re going to be hit with, and the complexity of the resulting pile, is going to be quite a site. We can all take comfort, in the months to come, that no matter what our jobs are or how crazy they get, that at least we’re not having to sieve through that heap of cooked oatmeal. Keep in mind that the Doudna and Zhang patents did not come in under the “first to file” patent regime that we have in place now. That would have made things substantially easier right now. Instead, they were filed during the last of the “first to invent” era – in fact, this may be one of the last big first-to-invent interference disputes. That means lab notebooks, emails, group meeting agendas, whatever day-to-day evidence of who thought of what first can and will be introduced into the proceedings. It’ll be a joy.
It looks now like the ruling is set up to be an up-or-down one: either the Zhang patent estate or the Doudna one will win big. Depending on how things go during the interference, though, there’s still a chance that the two sides could strike a deal – the more in doubt the outcome looks, the more motivation there is for that. But there’s another factor at work here: since these patents, there have been many variations and improvements on CRISPR, to the point that you have to wonder a bit if the winner of this dispute will end up winning quite as much as one might think. Will some of these newer, more specific and controllable forms of CRISPR turn out to have more valuable patent rights than the original? You also have to think that there will be specific techniques and tricks that will have to be applied to get the technology to work therapeutically in humans, which takes you into still more new IP space.
No, I think the courts are not through seeing CRISPR cases, not as long as it works as well as it does. At least these later disputes will be first-to-file ones!