What the CRISPR Patent Decision Means for Gene Editing

The U.S. Patent Office has finally ruled on the century’s biggest biotech discovery.

The biotech trial of the century is over—for now. On Wednesday, the U.S. Patent and Trademark Office decided in favor of the Broad Institute, which has been battling the University of California for the patent over CRISPR, a widely hyped gene-editing technique with applications in human medicine, agriculture, and beyond.

The ruling lets the Broad’s original CRISPR patents stand. Scientists based at the UC Berkeley and the Broad published papers about CRISPR’s use in gene editing in 2012 and 2013, respectively, and the two institutions promptly filed for patents. The Broad was awarded the first of a series of patents in 2014.

UC struck back, contending that the Broad’s patents “interfered” with its application—meaning the patents had overlapping claims—which set in motion the “interference proceeding” that ended today. UC said in a statement and it “respects” the decision but would consider legal options including an appeal. The ruling of no interference also means UC’s still pending patent application is up for approval again, though it’s unclear how such a patent, if approved, would interact with the Broad’s. For now, the Broad is ahead.

That’s a lot of legal wrangling—motivated by a lot of money at stake for the Broad and the University of California. If CRISPR is as widely applicable in biotech as many expect, whoever holds the patent could end up with millions of dollars in licensing fees from companies that want to use the technique to develop new therapies or products. There is precedent: An older genetic-modification technique from the 70s has netted Stanford and UC $255 million in licensing fees.

The stakes are heightened by how quickly companies have moved to license CRISPR patents and go public in $100 million IPOs—even as the very patents they rely on are in dispute. Intellia and CRISPR Therapeutics, which licensed UC’s patent, may be in a bind. Editas Medicine, on the other hand, which has an exclusive license on the Broad’s patent when it comes to human-therapy applications, is the biggest winner. Assuming the patent situation does not change, Editas will be the major player in human CRISPR therapies in the foreseeable future.

A host of big, established companies like DuPont and Monsanto have also licensed CRISPR technology for applications like agriculture. For these companies, the patent decision is not as big a deal. Editas’s human therapies aside, Broad is licensing its CRISPR patent non-exclusively, which means an ag company left in the lurch by the patent decision could probably just apply for a new non-exclusive license from the Broad.

I’m reminded of a conversation I had some months ago with Mario Biagioli, a historian of science at UC Davis, about disputed inventions. He spoke with the equanimity of an academic who can stay above the fray. When it comes to patents, he said, the point is to incentivize inventions. “The goal is that the invention is made by somebody, so who gave us that invention is not crucial,” he told me. That’s one way to see it.

In any case, it’s true that regardless of the outcome of the patent dispute, there would be no shortage of companies looking to commercialize CRISPR.