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The CRISPR Interference Case

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!

23 comments on “The CRISPR Interference Case”

  1. A Nonny Mouse says:

    Fun, fun, fun having been through this……….. The case is now taught in law school (medichem v. rolabo).

  2. bhip says:

    I am absolutely not a patent attorney & not up on the back story, but why wouldn’t you specifically address gene editing in mammalian cells in the initial patent application? Even if you only did it initially in nonmammalian cells (??), wouldn’t you claim it as a potential use? It is obvious to anyone skilled in the art but why open the door?

    1. NJBiologist says:

      If you claim it works in mammalian cells and then it doesn’t work well there, don’t you lose the entire patent?

  3. Anchor says:

    Not the same but reminds me of passionate and hostile battle between French and the US government for the AIDS virus discovery with Montaigne and Gallo on loggerhead during the Reagan administration. It was mutually settled but Montaigne walked off with Nobel! Gallo’s complaints (and protest) went unheeded. Wonder if any Hollywood movie came out that feud? CRISPER too headed in the same direction but within the US (hopefully).

  4. watcher says:

    It’s always seem to me that first to file is easier for the Patent Office, but often no fair to the actual first inventor who might not be so savvy on patent law. Would made sense that programs granting degrees in chemistry now should include instruction on patent law.

    1. Isidore says:

      Actually “watcher” makes a very interesting point: Do graduate schools these days require or even offer any instruction in patent law to students in the sciences? They certainly did not when I received my PhD two-and-a-half decades ago. And if not, do individual PIs take it upon themselves to educate their students and post-docs on the subject? As I recall only those relatively few students who did work deemed by the institution worth pretending became involved in the process, in fact one of my lab mates enjoyed it so much (!) that after receiving a PhD in Chemistry he went to work for a law firm as a technical consultant or such, and eventually received a law degree and has been doing patent law since.

      1. Sofia says:

        I had the insight during my professors patent discussions with the school to ask if I could drop by and goodness what a wealth of info that turned out to be. For the most part, though, students are blissfully ignorant of the fact that their work can be patented or that there are inventors rights. Most of the time they assume anything they develop belongs to the advisor or the school – which may or may not be the case depending on institution.

  5. Anon says:

    It’s obvious to me who will win this one: the lawyers (as usual).

  6. tally ho says:

    let the games begin.,,

    given that the whole world is using CRISPR now and that kits are commercially available, do CRISPR practitioners bother to license anything? i.e. will Doudna vs. Zhang be relevant to current business as usual? or is this more about who’s going to get a Nobel Prize?

  7. will says:

    Anchor – the movie “and the band played on” includes the dispute as part of a story arc of HIV in the 80’s.

    watcher – first to file harmonizes US law with the rest of the world, which is probably a good thing, also benefits large corporations who can afford to file early and often, at the expense of individual inventors and the like (although people can argue about this)

    1. Mark Thorson says:

      Agree that harmonizing the U.S. patent system with the rest of the world is a good thing. And I’d argue that this actually gives some individual inventors an edge. Some of us are very skilled at writing our own patent applications, so our only cost is a filing fee. Have the idea on Monday, file on Tuesday, and maybe you beat some big company by a day or more. When they write their patent, they’ll discover your prior art. Now that “first to invent” is out the window, they have less wiggle room for claiming priority. Your filing date is a hard rock they can’t move. I once worked for a giant corporation and discussed with one of their lawyers a prior art patent by an outside party that might have affected our work. He told me that if the patent had been issued by the patent office, his department would assume it was valid and we would try to negotiate a license if we needed one. They were prepared to fight, but they weren’t looking for a fight. The exception would be if I had some prior art that clearly anticipated the troublesome patent, and even then they’d try negotiating first. Things might be different in the pharma industry, where patents are more of an all-or-none type of thing, but then again CRISPR is a technique, not a drug.

      1. steve says:

        I have to disagree. First-to-file favors big companies (who have the resources to file quickly and often) versus small companies and individuals (who don’t). This was well-studied by Abrams and Wagner who compared what happened to the number of patents submitted in Canada by individuals when they changed to first-to-file versus the US (see Fig 4 on p. 546 at

      2. newnickname says:

        “Have the idea on Monday, file on Tuesday, and maybe …” Unless they’ve changed other aspects of the patent rules, you can’t patent IDEAS. Once again, big companies prevail over small entities because they have the resources to achieve reduction to practice, file quickly and then have the time to further expand their hold on the field. Contrary to the other respondent, I have heard stories of big companies pretty much robbing small entity patent holders blind by the threat of a lawsuit. Defending a patent against a challenge can bankrupt a small entity … then the big company just swoops in and buys the portfolio for a few measures of a song. If a small entity DOES sell or license to a big company, rest assured that the big company will find every possible way to file new patents to reduce the licensing fees to zero.

  8. mike b. says:

    And here I thought we did science not to become rich or famous, but to make the world a better place. Silly me.

    1. bad wolf says:

      @mike b: Glad to hear you can feed yourself on your own sense of smug self-satisfaction.

      1. Massimo Sandal says:

        Last time I checked, you didn’t need to be rich and famous to feed yourself. Most scientists can feed themselves comfortably.

  9. steve says:

    Aside from the issue with first-to-file that I mentioned earlier, the other issue that should be noted is that these are all methods patents. These are notoriously weak as an interested party can almost always invent around a methods patent. If someone had composition of matter on one of the enzymes then they might have something; with just methods patents it’s likely that both patents will eventually be superseded.

  10. Albert says:

    Do I understand it correctly that this fight is about US patents only? I assume Doudna and Charpentier (the latter being French) applied for it in Europe as well and there Zhang and colleagues have no chance. Of course it’s still a potentially very important fight.

    As for Nobel prize I think it will be either Doudna and Charpentier or all three.

  11. Picky Pixie says:

    “Quite a site” -> “quite a sight”

  12. anon says:

    Would the reported flurry of emails sent by the US patent office to MIT concerning their CRISPR filing be subpoenable?

    I am sure many would be very interested in knowing what those emails said.
    Probably best to seize them now before they mysteriously are lost due to a computer malfunction.

  13. Pingback: Discovering CRISPR

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