This essay appears in today’s edition of the Fortune Brainstorm Health Daily. Get it delivered straight to your inbox.
The patent fight billed as the “Ali-Frazier Fight of Biotech,” and a “clash of titans,” and the “last great priority dispute of the ‘first-to-invent’ era of US patent law” (um, okay, that final image is perhaps less evocative) had its first and only hearing before judges yesterday—and the line to get a glimpse of the brief proceedings wound its way around the lobby Christmas tree in the U.S. Patent and Trademark Office building in Alexandria, Virginia (a view of which can be found here, in lawyer Jacob Sherkow’s enthusiastic Twitter feed).
The battle, as I mentioned in my Oct. 26 post, is over who invented the revolutionary gene-editing technique known as CRISPR–Cas9. On one side are the Regents of the University of California and the University of Vienna (representing scientists Jennifer Doudna and Emmanuelle Charpentier, respectively); on the other is the Broad Institute of MIT and Harvard University (representing Feng Zhang). And, as I noted in the earlier post, the stakes are positively enormous, potentially affecting billions of dollars in future revenue, to say nothing of the valuations of several companies that have already launched to take advantage of this approach.
Doudna and Charpentier filed their patent applications first. Zhang filed later but managed to expedite his application and was actually awarded the patent. Team Doudna and Charpentier then filed what’s called an “interference” to invalidate Zhang’s claim—which was put in motion (er, “declared”) by the USPTO in January. (There’s more here on that Declaration from biotechnology patent lawyer Kevin Noonan at the terrific site Patent Docs.
No one doubts that Doudna and Charpentier announced their CRISPR–Cas9 discovery first—a revelation that ignited excitement in the scientific world. (Just do a Google search for “biotech discovery of the century.”) At issue is where they demonstrated CRISPR’s utility—in bacteria—and what that implies. Zhang, by contrast, showed specifically how the technique could be used in the more complex (eukaryotic) cells of rhododendrons, rodents, and humans. And the question now before the USPTO is whether Zhang’s discovery was an “obvious” extension of Doudna’s and Charpentier’s, or something truly novel and—if anything—more relevant to the bulk of scientific and medical applications now in the works. (The aforementioned Sherkow, an associate professor at New York Law School, has a great take on the cinematic twists and turns of the case—including some curious legal strategies and the mysterious role of an anonymous third party—at Stanford Law School’s infrequent but excellent Law and Biosciences Blog.)
To read the tea leaves—which is to say, the seemingly skeptical questions by the judges to the UC lawyers—Team Doudna/Charpentier had a rough day yesterday. The sense (again, to those who were interpreting questions and tone) was that the judges were less hospitable to the notion that Zhang’s work was a mere (and direct) extension of the UC team’s.
But whatever the merits of this specific case—and however the three judges rule—there is a broader issue that speaks to the reason we have patent laws in the first place. The ultimate aim of these invention protections is to accelerate the process of discovery and to expand the scope of public knowledge as quickly as possible.
One hopes that, whatever the USPTO decides in the Thrilla of Virginia, it doesn’t put a chill on scientific sharing. The biggest danger is that researchers will end up feeling ever warier of publishing their findings until they have the widest potential application. Why tell people where the oasis is, after all, if others will rush ahead to fence it off? Importantly, that’s NOT what I’m suggesting that either party has done in this case. But if that’s the message that comes out from the CRISPR ruling, then all of science will have lost.