Patent dispute clouds new gene editing technology CRISPR

Two groups claim ownership of the patents applicable to CRISPR – clustered regularly interspaced short palindromic repeats – which has shown potential to help medical researchers remove genetic aberrations behind many diseases. 

A coalition of the University of California, University of Vienna and Umeå University in Sweden is in dispute with the Broad Institute of MIT and Harvard, a specialist biomedical research facility, over the patent rights to CRISPR. Courts and patent offices across the world are considering the groups' respective rights in the technology in a legal process that does not look like ending soon.

The battle to control how CRISPR is applied is likely to be highly lucrative to the winner. Its potential commercial application is valued in the billions of dollars.

Already CRISPR has shown potential to treat diseases such as sickle cell anaemia, Duchenne muscular dystrophy, haemophilia and cystic fibrosis, as well as to enable genetic modification of plants and animals and assist in pest control. A number of research bodies are currently working to further characterise and refine CRISPR, reflecting the fact that it is an almost universally applicable tool capable of being customised easily, quickly and economically.

Establishing the right to control the use of the technology is therefore a major priority for both the University of California coalition and the Broad Institute.

Because CRISPR has many direct commercial applications, research and development (R&D) has not been stifled by the ongoing patent dispute. However, the dispute is a muddying factor.

One potential outcome is that both the University of California coalition and the Broad Institute could succeed with legal action that invalidates, or at least narrows the scope of, the others' patents and prospective patents for CRISPR technology. This would mean that both groups could lose control over which other companies could enter the market.

While the removal of patent shackles would be welcomed by some, for example those who wish to have unfettered access to the technology, the companies and   investors affiliated with the University of California coalition and the Broad Institute have spent significant time and effort developing the technology and would not welcome that outcome.

Further, the loss of patent protection could make companies less inclined to invest in developing CRISPR further. This could mean the full potential of the technology remains untapped.

It is possible that the groups behind CRISPR technology could end up with different patent rights in different jurisdictions.

For instance, although the majority of the patent applications made by the University of California coalition are still undergoing examination in Europe, two patents have already been granted to it in the UK. On the other hand, the Broad Institute has already secured a number of patents in Europe.

China, which is a serious contender in the race to further develop CRISPR, has not granted patents to either of the two parties. However, patents covering CRISPR applications have been awarded to a number of Chinese applicants.

Patent applications filed by other research groups may also be relevant. Less high-profile applications include those filed by Toolgen and Sigma Aldrich. In the US, one of the Toolgen patent applications was rejected on the basis that it failed to describe the invention. However, equivalent applications in Korea and Australia have been granted.

This chequered patent landscape could therefore lead to different groups having monopoly positions in different parts of the world. Those groups would then have to collaborate to reach different markets.

There are a number of further issues relating to the licensing of CRISPR technology to consider too.

Although both the University of California coalition and the Broad Institute have licensing agreements in place with third parties for use of their technology, most of the groups' patents and patent applications have multiple applicants. Due to differences in the rights of co-applicants/co-owners in different territories, this could add an additional layer of complexity to an already complicated situation.

For example, under US patent law, each patent owner has the right to grant licences without the consent of co-owners. In contrast, under UK law, a co-owner must seek consent of the other co-owners in order to do so. Such a situation could necessitate the formulation of bespoke licensing strategies in different territories.

So-called reach-through royalties could also be of concern. This is where technology owners demand royalties on any marketable product created using their technology. The inclusion of such claims in the patents could mean that third parties may be forced to obtain licences to patents they had not previously considered relevant.

One potential outcome, which could simplify licensing while respecting the patent rights of multiple parties, would be the formation of a patent pool where patent holders come to an agreement to license one or more of their patents to one another or to third parties through a centralised licensing mechanism. Such patent pools, which are common in the technology sector, could make access to important patents easier. Already, world licensing company MPEG LA is inviting holders of CRISPR patents to pool their rights and participate in the creation of a global CRISPR joint licensing platform.

Further ethical issues could also arise, however, particularly as further work is done to explore the potential for CRISPR to make inheritable modifications to DNA and the creation of novel life forms with specific traits.

As with any powerful technology, regulatory oversight is likely to be necessary for CRISPR. The ease with which the technology can be employed may make its control more challenging than usual. Ultimately, any victor in the patent disputes may find itself having to protect the ethical interests in the technology and essentially be obliged to act as a gatekeeper of its application.

Thus, despite the obvious commercial attraction of prevailing in the ongoing patent battles, the requirements of having to play such a role are likely to be unattractive to companies engaged in the development of CRISPR tools, as this could introduce a legal and reputational risk to those entities.

The ongoing battle to control CRISPR could, of course, lose importance if future discoveries or improvements supersede the existing way in which the technology is used. It might also be possible for researchers to work around existing patents to take the next inventive step in the application of the technology. Where new processes are found, they too could qualify for patent protection and be the subject of further disputes in the market.

In addition, CRISPR could be superseded by alternative genome editing technologies. In this regard, NgAgo, a DNA-guided endonuclease, has already shown some promise and is under investigation.

Currently, there is no end in sight to the dispute regarding the ownership and validity of the key patents protecting CRISPR. Given that the major parties appear to be well funded, and considering the number of parties who have or are likely to stake a claim to the CRISPR technology, it appears likely that this battle will rage on for some time.

It might be that the battle to control CRISPR is eventually settled out of court. Until then, the dispute is likely to be a cloud over the way the gene-editing technology is used, developed and licensed. 

Asawari Churi is a trainee patent attorney at Pinsent Masons, the law firm behind Out-Law.com and a former research scientist in molecular biology. A version of this article was first published by Bio-science Law Review.