The first CRISPR cure might kickstart the next big patent battle
And really, what’s the point of such a hard-won triumph unless it’s to enforce your rights? “Honestly, this train has been coming down the track since at least 2014, if not earlier. We’re at the collision point. I struggle to imagine there’s going to be a diversion,” says Sherkow. “Brace for impact.”
The Broad Institute didn’t answer any of my questions, and a spokesperson for MIT didn’t even reply to my email. That’s not a surprise. Private universities can be exceedingly obtuse when it comes to acknowledging their commercial activities. They are supposed to be centers of free inquiry and humanitarian intentions, so if employees get rich from biotechnology—and they do—they try to do it discreetly.
There are also strong reasons not to sue. Suing could make a nonprofit like the Broad Institute look bad. Really bad. That’s because it could get in the way of cures.
“It seems unlikely and undesirable, [as] legal challenges at this late date would delay saving patients,” says George Church, a Harvard professor and one of the original scientific founders of Editas, though he’s no longer closely involved with the company.
If a patent infringement lawsuit does get filed, it will happen sometime after Vertex notifies regulators it’s starting to sell the treatment. “That’s the starting gun,” says Sherkow. “There are no hypothetical lawsuits in the patent system, so one must wait until it’s sufficiently clear that an act of infringement is about to occur.”
How much money is at stake? It remains unclear what the demand for the Vertex treatment will be, but it could eventually prove a blockbuster. There are about 20,000 people with severe sickle-cell in the US who might benefit. And assuming a price of $3 million (my educated guess), that’s a total potential market of around $60 billion. A patent holder could potentially demand 10% of the take, or more.
Vertex can certainly defend itself. It’s a big, rich company, and through its partnership with the Swiss firm CRISPR Therapeutics, a biotech co-founded by Charpentier, Vertex has access to the competing set of intellectual-property claims—including those of UC Berkeley, which (though bested by Broad in the US) hold force in Europe and could be used to throw up a thicket of counterarguments.
Vertex could also choose to pay royalties. To do that, it would have to approach Editas, the biotech cofounded by Zhang and Church in Cambridge, Massachusetts, which previously bought exclusive rights to the Broad patents on CRISPR in the arena of human treatments, including sickle-cell therapies.
