How’s this for strange? What’s likely the most important biotech patent battle of the decade is now being fought under outmoded rules that the U.S. Congress, in a rare spasm of common purpose three years ago, agreed roundly were due for a once-in-a-lifetime overhaul.
The fight is over CRISPR/Cas9, a potential Nobel-winning biotech discovery, and shorthand for a new way to edit and otherwise modify genomes. As a biologist’s research tool, it’s already invaluable. As a medicine, it could fulfill the promise of gene therapy, snipping out faulty genes that cause disease, perhaps replacing them with new, improved ones.
Who invented it and when is the subject of the fight which, like battles over other once-in-a-generation biotechnologies such as RNA interference, monoclonal antibodies, and polymerase chain reaction, could have consequences that resound for decades.
President Obama signed the America Invents Act—a reboot of the U.S. patent system—in 2011. The old system awarded patents to those who were first to invent; the new system rewards those who are first to file a patent application. Because of the grinding gears of putting laws in place, the CRISPR/Cas9 case revolves around the old paradigm—who was first to invent key aspects of the technology. Yet as we’ll see, some aspects of the new rules apply, too. Patent strategy is tricky enough as it is, but this is like playing three-dimensional chess on two different boards.
“There’s a lot of speculation about what can happen and lots of permutations,” says Chelsea Loughran, a patent attorney with Wolf, Greenfield & Sacks in Boston. (Loughran and her colleague Pat Granahan have been tracking the CRISPR/Cas9 IP situation for some time but have no ties to any parties involved.)
The scrum is all the more intense because the technology is fast to build and easy to use. Within a couple years of its invention, it has caught on across the world with scientists who want to cut out or replace genes in organisms from bacteria to mice to monkeys. Work in human cells is starting to emerge, too. New ideas and new uses seem to pop up every day.
“The time frame is so compressed here,” says Caribou Biosciences chief scientific officer Andy May. “The foundational work and the improvements are happening so much closer than in previous instances [of new biotechnologies]. Usually those improvements take many years to develop.”
In a conversation last week, May stressed to me he couldn’t talk about anything patent-related. As I wrote about last month, Caribou has teamed up with Intellia Therapeutics of Cambridge, MA, one of three for-profit startups in the race to turn CRISPR/Cas9 into the latest form of gene therapy. Intellia has exclusive license to Caribou’s suite of CRISPR/Cas9 technology for human therapeutic use.
Caribou’s IP stems from the University of California, Berkeley, where biochemist Jennifer Doudna worked on a crucial idea with others at Berkeley and beyond. They took a defense system that bacteria deploy against viruses, first discovered a quarter-century ago by Japanese researchers, and made key changes that turned the system into a gene-modification tool. They published their work in Science in 2012.
They filed a patent application in March 2013, just before the system switched from first-to-invent to first-to-file. The patent has not yet been granted.
Doudna’s co-inventor, Emmanuelle Charpentier, who has posts at institutes in Sweden and Germany, assigned her portion of the rights not to Caribou but to Crispr Therapeutics, a group founded by Versant Ventures in London. (I wrote about Charpentier’s decision and much of the background of the story for Start-Up earlier this year.)
Here’s where things get a bit twisted around. Until recently Doudna had ties
