This week the US Patent Trial and Appeal Board decided that there is “no interference in fact” between the patent application of Jennifer Doudna and University of California and the patents granted to Feng Zhang and the Broad Institute of Harvard and MIT. You can read the full text of the decision here.
Media reaction: Hype!
The immediate reactions put this as a big win for the Broad Institute in as many combative terms as possible. Fight, battle, and war were all used to describe the legal patent interference case being settled and most headlines pronounced the war to be over. Obviously this has been a huge court battle worth enough to merit legal bills going into the tens of millions of dollars, but many experts have noted this is not necessarily the winner-take-all patent fight that many headlines suggest. The interference proceedings were to determine if the set of patents granted to the Broad Institute for CRISPR-Cas9 editing in eukaryotic cells interfere with the patent application from the University of California (UC) that was filed first and tries to generally cover the use of CRISPR-Cas9 in living cells.
This decision does mean that barring a successful appeal at the Federal Circuit Appeals Court, the Broad Institute will get to keep the patents using Cas9 to do genome editing in eukaryotic cells–which includes human cells–so that is key to companies that had licensed those patents to develop human therapeutics. The UC patent application tries to make a broader claim to editing in all living cells, which would naturally include eukaryotic and human cells. If UC gets the patent on the broad use in living cells and the Broad has the patents on use in eukaryotic cells, we may still end up in a scenario in which licensing of both patents is necessary to edit eukaryotic cells. Some good reporting that helped me understand this can be found here, here, here, here, and here. After the initial rush to announce the epic end to this patent battle, time allowed for more nuanced and thorough reporting to lay out the remaining uncertainty and caveats.
Market reaction: Follow the hype!
Following the main narrative of the Broad Institute scoring a big win in its ‘epic battle’, the market traders pushed Editas (aligned with Broad) stock about 30% throughout the day and Intellia (aligned with UC) stock dropped nearly 10%. It’s hard for me to tell how much the decision actually has on the value of these companies because it seems like that will depend on how licensing or cross-licensing options work out for any given application. I’ve yet to find much analysis that could definitively map out how the patent licensing will affect medical innovation using CRISPR-Cas9, but that may still be too variable for anyone to know right now.
There was a lot of discussions of the possible ways this could play out in the biotech and gene editing industries depending on the course that UC takes after the interference defeat. The tweet below from CNBC reporter Meg Tirrell outlines three possible options.
UC Berkeley’s reaction: Unexpected positivity
From the initial headlines, we would expect Berkeley to put out a defensive or negative statement about the decision against interference in favor the Broad’s patents on CRISPR in eukaryotic cells. What we got was a positive take on the patent application that Doudna and Berkeley still have on using CRISRP-Cas9 in any cell. In a conference call Jennifer Doudna said, “They will have a patent on green tennis balls. We will get a patent on all tennis balls.” This analogy relates to the legal idea notions of how patents on a category of thing (genus) and member of that category (species) relate. You can read the US Patent Office’s more thorough explanation here, but the idea is that if you have a patent on a category of thing–like a tennis ball–then someone can still patent a new part of that category–the green tennis ball. But if you have a patent on green tennis balls first, someone cannot go back and patent all tennis balls because in patent language the tennis ball has already been “anticipated” by the “prior art species” (see here for USPTO explanation). However, as UC’s patent application goes forward it’s also possible that it gets restricted to just bacterial cells which would be something like blue tennis balls.
The text above shows that the panel of judges used this notion of genus and species when discussing why there was not interference between the two claims. This is the logic that makes it possible for the University of California to argue for a patent on using CRISPR-Cas9 in all living cells and then have the Broad Insitute get patents for using CRISPR-Cas9 more specifically in eukaroytic cells like human cells. The argument for keeping the Broad patents relied on it not being “obvious” for the CRISPR-Cas9 system that was known to work in bacterial cells or in a test tube to also work in eukaryotic cells. Again, obvious is a term that has a particular specific meaning in patent law aside from what you might naturally call obvious. You can read about the legal definition of obviousness, but for now the Broad’s patent claims were deemed not obvious from UC’s claims. While that’s very good news for the Broad Institute, the University of California seems to think that they’re not shut out since they still have a shot at the genus level patent.
Broad Institute’s reaction: Reserved excitement
The Broad Institute was of course pleased to see the three judges decide that there was no interference between the patents. They put out a statement that “agree with the decision by the patent office, which confirms that the patents and applications of Broad Institute and UC Berkeley are about different subjects and do not interfere with each other.” The Broad’s statement even tried to acknowledge the other researchers’ work and show “deep respect for all of these scientific contributions, including the work from Emmanuelle Charpentier, Jennifer Doudna, and their teams, as well as all of those who continue to advance the field and educate the public about this important technology.”
They likely wanted to avoid anything like the backlash that came from Broad director Eric Lander’s “The Heroes of CRISPR“. The perspective piece in Cell struck many as self-serving and dismissive of work done by others like Jennifer Doudna and Emmanuelle Charpentier. By contrast, the press release and lack of promotion of the decision in their favor tried strike a more humble tone. But even if they don’t want to show it, there were surely reasons for people in the Broad to celebrate this week.
My reaction: Still a little confused
After all of this I’m still a little confused at how this impacts the pursuit and price of therapeutics developed using CRISPR-Cas9, but I’ll keep following the story because it has a lot of potential to affect how medical treatments are developed and how patents are viewed within the research community. We’ll have to wait for UC to decide on their next legal steps and then see how the universities and companies find deals to allow the gene editing tool to be used. Access to using CRISPR at the academic research level should remain unchanged but ability for those projects to turn into breakthroughs in hospitals will depend on the continued legal fallout.
Conflicts of Interest
I am affiliated with the Broad Institute because I work in an MIT lab that also has space within the Broad Institute. I do some lab work within the Broad Institute, have friends in the Broad, and have friends/collaborators from Feng Zhang’s lab. I have no financial interest in any of the companies discussed nor have I worked on any of the Cas9 related research. I do not speak for the Broad Institute in any way and this post only reflects my personal summary of the reactions to the recent patent decision.