CRISPR: A twist in the tale in the ongoing patent battle in Europe

CRISPR mediated gene editing technology is an efficient and highly selective technique that allows the DNA of organisms to be easily and precisely modified. It is undoubtedly one of the biggest breakthroughs in biotech in recent years. Indeed, Jennifer Doudna, and Emmanuelle Charpentier, were jointly awarded the Nobel Prize for Chemistry in 2020 for its discovery, with the Committee not only describing it as “one of gene technology’s sharpest tools” but also stating that:

“There is enormous power in this genetic tool, which affects us all. It has not only revolutionised basic science, but also resulted in innovative crops and will lead to ground-breaking new medical treatments”.

Unsurprisingly given its game changing nature, since its discovery there has been a great deal of activity and interest in CRISPR-mediated gene editing across multiple sectors. As a result, not only have many patent applications been filed – and subsequently granted – to the underlying technology, but they have also been the subject of a series of high-profile ownership disputes. Institutions including Vilnius University (who filed first but have an invalid priority claim), the University of California/University of Vienna/Charpentier (‘CVC’; who have the earliest priority date, and who include Jennifer Doudna, and Emmanuelle Charpentier, among the inventors), the Broad Institute/MIT/Harvard (‘Broad’), Sigma, and Toolgen, have all filed applications to various aspects of the underlying technology.

Over the course of the ten years since applications were first filed, the parties have been locked in numerous patent disputes in both Europe and the US.

As we previously reported (here and here) CVC initially appeared to have the upper hand in Europe, with the European Patent Office (EPO) maintaining two of their patents related to the use of CRISPR in eukaryotes, EP2800811 and EP3401400, at first instance. In contrast, Broad, who filed later but who obtained a first granted patent more quickly due to an aggressive filing and prosecution strategy, lost one of their patents, EP2771468, which was also related to the use of the system in eukaryotes. The patent was revoked because the claims were found to lack priority and, thus, to lack novelty.

Meanwhile, the reverse is currently the case in the US. The Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (UPSTO) ruled that Broad owns the intellectual property for the use of the CRISPR technology in eukaryotes. In the decision, the PTAB acknowledged that CVC developed the CRISPR system in 2012. However, they ultimately concluded that whilst CVC had hoped that the system would work in eukaryotes at that time, they “did not have a definitive and permanent idea of how to achieve that result as of that date”. In another blow to CVC, the PTAB found their claims to the use of CRISPR in eukaryotes to be unpatentable.

However, the story does not end there, and there has now been another twist in the tale.

Although EP2800811 and EP3401400 were maintained at first instance in Europe, the decisions were appealed. An oral hearing before the Board of Appeal was scheduled for later this month. However, in a major development, CVC have now requested voluntary revocation of the patents. As such, the patents will be revoked without the parties having opportunity to argue their case, and the hearing has been cancelled.

The EPO recently issued its preliminary opinion ahead of oral proceedings. It was the initial view of the Board of Appeal that the claims of the patents were not entitled to the claimed priority date. As such, the claims were thought to lack novelty and inventive step in view of a scientific paper co-authored by Doudna, and Charpentier, that was published in 2012 (Jinek et al, ‘A programmable dual-RNA-guided DNA endonuclease in adaptive bacterial immunity’, Science, 337 (6096): 816–821). The paper described the use of a ‘single guide’ RNA in prokaryotes for the first time. The Board of Appeal were also of the preliminary opinion that the patents were not sufficiently disclosed because they lacked information on important technical features meaning that a person skilled in the art could not work the invention.

In their letter to the EPO requesting revocation, CVC insist that the claims of the patents are valid. Nevertheless, by not defending the patents, and instead voluntarily giving them up, it appears that they have avoided an adverse decision from the Board of Appeal, which would have been binding (assuming, of course, that they were to be unsuccessful in changing the preliminary opinion). By avoiding such a decision, CVC may have mitigated the effect that it would have inevitably had on related cases.

It is worth noting that CVC withdrew its approval of the text as granted. As such, although the EPO is technically within its rights to assess the facts of its own volition, in this case there is nothing on which it can base a substantive decision. This is because there is no text approved by the Proprietor in respect of which it could make a decision upon.

As well as adding a further twist in the long-running CRISPR patent saga, the present case perhaps highlights that not all victories are equally as sweet. Although revocation is the outcome the opponents were hoping for, of course, there has been no substantive decision from the EPO to that effect. Conversely, whilst CVC have lost the patents at issue, they have avoided the possibility of the Board of Appeal issuing a negative decision which could have had knock-on effects for their related patents.

As ever, it is very unlikely that this is the last we have heard on the matter.

Sarah Gibbs, Appleyard Lees