HEALTH

Who Owns Gene Editing? A Winner In High-Stakes Patent Battle Decided

MIT, Harvard scientists win 13 disputed patents related to revolutionary technology

HEALTH
Illustration: Diana Quach
Feb 16, 2017 at 1:56 PM ET

A war over one of the most innovative bioengineering technologies developed in recent times has had its first battle settled. And it may cost the losers a huge chunk of the profits to eventually be made from it.

On Wednesday, the federal Patent Trial and Appeal Board issued its 51-page ruling on the ownership of more than a dozen patents related to the gene editing technology known as CRISPR-Cas9. It held that the patents rightfully belonged to MIT’s research center the Broad Institute and Harvard University, which originally filed them, rather than to the University of California, which sought to have the patents retroactively awarded to them.

The decision marks a pivotal point in a long-standing feud over which scientists deserve the bulk of the credit for making CRISPR a reality.

The debate over CRISPR’s patents is a weighty, complex one, as publications like STAT News have diligently detailed. But the short of it is that in 2012, biochemist Jennifer Doudna and her team at University of California, Berkeley published the first research showing that a rudimentary immune system used by many bacteria — CRISPR — could theoretically be used to edit any cell’s genes on command. Several months later, however, the Broad Institute, led by scientist Feng Zheng, was the first to use CRISPR to actually edit mouse and human cells.

Doudna and UC Berkeley were the first to file patents on the real-world applications that would emerge from CRISPR, but didn’t receive preliminary approval from the Patent Office until after the 13 patents requested by Zheng and the Broad Institute were granted, thanks to the Institute paying extra to have their application fast-tracked. UC Berkeley argued that this go-around represented an interference of their rightfully deserved patents, and earned an opportunity to dispute the patents obtained by the Broad Institute in January 2016.

Lawyers for the Institute claimed that Zheng’s use of CRISPR in human cells represented a clear and innovative advance of the technology, entitling them to the patents for any application related to its use in basically every non-bacteria animal. UC had argued that just about any scientist with reasonable expertise would have eventually made the leap to human cells, and that their pending patents related to using CRISPR in all cells superseded the Broad Institute’s ones.

More Scientists Will Soon Begin First Human Gene-Editing CRISPR Trial

Far from an arcane legal struggle, the Patent Office’s decision to agree with the Broad Institute and leave things as they were carries big implications. Several biomedical companies, including those founded by Zheng and Doudna, have already licensed patents obtained by either. And when the eventual drugs and therapies developed from CRISPR reach fruition, it’ll likely affect how much of a profit each respective patent holder stands to make. Already, there are clinical trials aiming to use CRISPR to treat everything from lung cancer to devastating genetic diseases.

In a statement made after the decision, UC Berkley said it respected the Patent Office’s decision and that it fully intends to finish the process to have its pending patents approved. At this point, though, the university hasn’t decided yet whether they will pursue an appeal.