Broad Institute in the raging CRISPR patent battle with University of California (UC) recently lost their European patent through a simple filing error. How did this come about? And how do you prevent this from happening to you?
Let’s quickly look at CRISPR, and why it’s such a hot and contentious topic at the moment, and then what the patent lawyers did wrong.
The tables might have just turned in Europe, when the European Patent Office decided last January to revoke a granted patent in the heated CRISPR battle, due to an incorrect chain of entitlement. CRISPR/Cas9 is a novel gene-editing tool involving “molecular scissors” (Cas9) guided by a “molecular sat-nav” (a guide RNA) to a gene of interest. Whilst questions remain surrounding the ethics, the safety and the legislation of genetic editing, this technology holds much promise for agriculture and medicine. In particular, hereditary diseases, such as cancer, could soon be a thing of the past, particularly in light of recent, encouraging scientific progress where the precision of the technology was found to be improved.
The gene-editing potential of CRISPR technology was recognised as early as 2008 but it was only in June 2012 and January 2013 that the technology was successfully used to alter DNA, first in vitro, then in human cells. Although researchers initially attempted to collaborate, the group rapidly broke up, resulting in the formation of multiple spin-offs and a fierce patent battle between those represented by University of California (UC) and those by the Broad Institute.
Thus far, the Broad group has been prevailing in the United States. In Europe, it is a different story. On 17 January 2018, the European Patent Office (EPO) revoked a key patent granted to the Broad group (EP 2771468), which claimed priority from US patents, the first of which was filed in December 2012. The reason? A discrepancy between the applicants on the patent and those listed on the priority documents.
In the United States, a patent application may be filed in the name of the inventor. When there is an assignment from the inventor to the new applicant occurring after the filing date, the assignment does not need to occur before filing a PCT application. This is because US law only requires a subsequent application claiming priority from an earlier application to have at least one joint inventor in common, i.e., not all inventor-applicants need to be listed when filing the PCT.
In Europe, however, all the applicants need to be included on a patent application at the time of filing. Should this not be the case, then claiming the priority of an earlier application is invalid.
In this case, priority documents included Luciano Marraffini as an inventor, but he was excluded from the subsequently-filed PCT document upon which the now revoked European patent was based. Furthermore, there appears to be no assignment of his rights to the Broad Institute, the applicant, prior to the PCT filing. Therefore, Luciano Marraffini was an inventor and applicant on the priority document, but did not transfer his rights to the Broad group before the PCT was filed. This means that, under European patent law, one of the applicants of the priority documents was missing at the time of filing the subsequent PCT. In essence, the chain of entitlement was not clear and the claim to priority was invalid.
As EP 2771468 could no longer rely on the earlier priority date, the EPO then found that intervening disclosure had occurred. This means that material, disclosed within EP 2771468, was already known at the time of the European filing. Therefore, EP 2771468 was no longer a valid patent.
The decision to revoke EP 2771468 could give UC the upper hand in Europe. However, the Broad group intends to appeal this decision, so the patent battle is far from over.
What lessons can be learnt from this saga?
- Firstly, perseverance can lead to major breakthroughs down the line.
- Secondly, have the proper chain of entitlement in place at the time of filing. Particularly in territories outside of the USA, failure to do so may not be rectifiable, and can be the difference between being able to claim priority or losing out to a competitor.