Recent patent wars over CRISPR technology platforms have made patents for these technologies less valuable.
In-house sources say that because patents for CRISPR/Cas9 gene-editing technologies have been subject to dispute between different universities and research groups, innovators in the space do not know who to turn to for a licence.
For American biotech and agriculture firms, the US disputes make any hope of a patent pool unlikely.
“I’m not sure a patent pool will happen because there is still some bad blood between universities and they are fighting it out,” says Reggie Gaudino, president and director of IP at Steep Hill Labs, a California-based cannabis testing company.
He says that ongoing battles between the University of California, Berkeley and the Broad Institute of MIT and Harvard have created uncertainty.
The research manager for IP at a Dutch biotech company adds: “The first CRISPR/Cas9 technology was claimed by something like six different groups. These groups are still fighting five years later over who has the rights to this and there is something like 1,600 patents filed.
“It’s a jungle. It would be very difficult for us to know which party to go to for a licence,” he adds.
Gaudino says that “it’s not even close to being over,” adding: “Everybody’s patents might be invalidated anyway.”
And with the pace of technology moving faster than innovators can file patents, many in the industry are questioning whether patents are worth the money and resources it takes to get them. “The technology is moving on because every few years something new comes out,” says Gaudino.
Across the pond
In Europe, in-house counsel say a December ruling from the Court of Justice of the European Union (CJEU) that plants produced through mutagenesis fall under the regulatory framework of the EU Genetically Modified Organisms (GMO) Directive has dampened the appetite for CRISPR patent pools.
“These new rules affect us because regulatory costs are very high and the market for GMOs in Europe is very limited. Of 28 member states, 19 have opted out of GMO cultivation,” says Petra Jorasch, manager of plant breeding and innovation advocacy at Brussels-based Euroseeds.
“So in Europe companies will most likely not use CRISPR, especially small and medium companies. Bigger companies will move their R&D out of Europe and change the focus of product development.”
The inability to commercialise products derived from CRISPR technologies in Europe means that many in the industry will use more traditional methods of mutagenesis instead of the gene-editing platforms.
“In Europe, anyone using CRISPR gene-editing platforms would have to declare if they want to bring the product to market. As of today there will not be products because of this ruling. You will continue to have people exploring it and using it, but mostly outside of Europe,” says the head of IP at a French agro company.
He says that even without the CJEU ruling, licences for CRISPR patents would not align with most agricultural companies’ business models.
“If you applied the same business model you have in chemicals and medicine, it would be too expensive for agriculture. In pharma you can have one drug that makes 40 or 50 billion dollars. But the seed business is very small and we could not afford the same licences. We are just not on the same scale.”
Money aside, he is not convinced that those who have patents to the various CRISPR platforms would pool them together, even though “a pool where people could find one single ticket and work with the technology would be great.”
“Just because it is a great piece of technology, not everyone wants to share a piece of the cake,” he says. He adds that because there are many different patents in the sector, a pool would be an easy way for small companies to know where to get a licence. But again, he adds: “You need to navigate the patent maze, and that is where things get very tricky.”
Stunted growth
Although the CJEU ruling prohibits European biotech and agro companies from marketing products created using CRISPR technologies, it does not prohibit them from patenting them.
But unfortunately for those in agriculture, even with the ability to patent the technology, European opportunities are stunted because of the court’s decision.
“The CJEU decision makes European seed companies much less attractive. Russia even announced they would deregulate and allow CRISPR,” says the research manager for IP at the Dutch biotech company.
“There is no scientific argument against GMOs. The fact that you are playing in a lab is sufficient enough to say it is a GMO. The regulatory hurdles are too costly so it’s too expensive for companies to produce CRISPR products for the European market,” he adds.
In order to get products to market which use CRISPR gene-editing platforms, reforms would need to be made to the European GMO Directive.
Ángela Martínez, manager of IP and legal affairs at Euroseeds, says: “We would want to see products created by any form of mutagenesis excluded from the GMO Directive. That would keep all these plants into the conventional breeding system and they would still be regulated as conventional varieties and go to market.”
She adds decisions to patent will be made on a case-by-case basis on plants developed by the new targeted mutagenesis techniques like CRISPR.
“The simple recreation of a natural mutation will most probably not fulfill patentability criteria. In addition, if other parties can easily invent around a patent, there might be no business care.”
Agricultural companies aside, the losers of the ruling potentially include all Europeans.
“The CJEU ruling that CRISPR falls under the umbrella of GMOs reduces the competitiveness of the agricultural sector and the choice for European farmers on available products. Our food and agriculture systems are less diverse and sustainable,” says Jorasch at Euroseeds.
Until American patent disputes are settled and European reforms made, the likelihood of any CRISPR patent pools emerging seems a distant prospect.
