CRISPR skirmishes at the USPTO are fostering uncertainty in the gene-editing space and putting licensees on edge as they wait to see who will own what when the dust settles.
Last summer, the scuffle between the two largest CRISPR patent owners – the University of California Berkeley and the Broad Institute – was reignited when the USPTO posted documents declaring interference between their patents – meaning that they might cover overlapping IP.
A month later, biotech company Sigma-Aldrich filed an interference petition and added another player to the mix; although said petition was dismissed by the Patent Trial and Appeal Board in September.
And this month it was announced that UC Berkeley now has the largest CRISPR-Cas9 portfolio, after a five-week spate of patents for the gene-editing technology being awarded to the university by the USPTO.
In-house sources say they are hesitant to go ahead with licensing deals while these patent wars continue because licensing decisions must be informed by factors such as which entities own what, how broad certain technologies are and where the application overlaps are.
“It is always positive for the rest of the community in this space to know who owns what patents so we can go ahead with licensing decisions,” says the head of IP policy at a pharmaceutical company in the US. “Finality and clarity is needed in the long run.”
Limagrain head of IP Franck Coutand in France adds that the lack of clarity could delay the adoption of CRISPR technologies in agriculture as well because stakeholders will not want to take a licence until they find out where they need to get one.
“I’m not sure anyone knows who to pay at the moment,” he says. “Lots of people and companies don't have any problems getting licences for the things they need, but if they don’t know where to get good tools, that uncertainty leads to speculation.
“It forces them to wait and see who the owner will be. It is difficult to know precisely when the dust will settle.”
He adds that agricultural players, and perhaps human therapeutics players too, do not want to have to pay twice for the same rights.
Laurie Hill, vice president of IP at Genentech in California, says that most therapeutic players are similarly waiting to see how and when the matter will sort itself out.
Sources noted in an article published by Patent Strategy last February that the lack of clarity surrounding who owns which patents is a key reason why a CRISPR patent pool is unlikely to emerge any time soon.
CRISPR – which stands for clustered regularly interspaced short palindromic – was first identified as a cheap, effective and usable gene-editing tool in 2012. That discovery led to a patent boom in 2013 and an increasing number of year-on-year applications.
Innovation momentum
Despite the uncertainty surrounding CRISPR patents, in-house sources are confident that innovation will continue.
For those players in the human therapeutics and agricultural industries that have already taken a licence, it should not be too difficult to change those arrangements as the CRISPR-Cas9 patent ecosystem alters.
“We’re not hugely worried about whoever comes out with which patents,” says the US pharmaceuticals head of IP policy. “If we have to make changes to licensing arrangements, as you always do when IP changes hands, then we will.
“I cannot comment on what licences we have, of course, but to the extent that we have licences that are impacted by these patent office skirmishes, those changes will not fundamentally disrupt work in the CRISPR space.”
Sources add that while the patents owned by UC Berkeley and the Broad Institute are important patents because they are early rights surrounding the gene-editing technology, they are not the only CRISPR-Cas9 patents out there. Other smaller players, including Duke University, have IP that is not affected by the patent office wars.
Furthermore, some businesses are exploring other forms of CRISPR beyond Cas9, including Cas12, in an effort to find an even better gene-editing tool that falls outside the UC Berkeley and the Broad’s reach.
As such, innovation in this space is likely to continue. The US pharma head of IP policy points out that organisations are interested in advancing CRISPR technologies, and that so long as the impetus is there, these skirmishes at the patent offices are very unlikely to completely derail efforts.
