EPO clarifies reasons for CRISPR patent ruling

Out-Law News | 16 Nov 2020 | 11:31 am | 2 min. read

The European Patent Office (EPO) has now clarified its reasoning behind the decision to find against the Broad Institute of Massachusetts Institute of Technology (MIT) in the latest round of a major patent dispute concerning rights to commercialise the revolutionary gene editing technology CRISPR.

In January 2020, the European Patent Office's Board of Appeal (BoA) ruled that a European patent owned by the Broad Institute be revoked after it dismissed the institution's claims over its patent's priority date. 

The EPO has now issued its long-awaited written reasoning behind this decision.

Usually, a patent’s filing date is the date at which its validity is assessed. Sometimes, however, the patent may claim an earlier date, the priority date, from a previous patent application disclosing the invention.

In this case, the priority date for the patent was particularly important as there are other many institutions and researchers that claim to have made discoveries on CRISPR prior to the Broad Institute.

In 2018, the EPO's Opposition Division held that the patent in issue was not entitled to its priority date. The original patent application was filed in the US, with four named inventors. However, when the patent was filed in Europe following the international patent procedure, one of these inventors was not included on this subsequent European application.

The Opposition Division therefore held that the patent was not entitled to its priority date and consequently lacked novelty, in other words, because of intervening publications, it was not considered to be a new invention. 

The Broad Institute appealed and argued that the EPO's approach to priority was incorrect and that US law should govern the interpretation of certain provisions when the priority application was filed in the US, as it was in this case.

The BoA dismissed the appeal, and now, having published its written decision, has confirmed that it did have right to decide on priority entitlement. It found that EPO case law on the issue of priority was well established and that it should not deviate from this. It also found that all applicants must be listed on both an initial application and subsequent application to be entitled to priority.

Asawari Churi, a member of the life sciences team at Pinsent Masons, the law firm behind Out-Law, said: "While this decision is perhaps unsurprising, given the EPO's longstanding practice, it provides welcome confirmation on the EPO's approach for priority. " 

The Broad Institute has a number of other patents which are also vulnerable on this same priority point.  Churi said: "It is highly likely that these patents, as well as any other patents affected by the same problem, will also be substantially or wholly revoked." 

However, as Churi notes, this is unlikely to be the last we hear about the CRISPR patent wars.

"The Broad Institute is one of many players with patents and pending patent applications in this field." Churi said. "There are also patents, and patent applications covering later, more specific inventions and platforms. This, and the potential uses of such platforms, means that such disputes are likely to continue for years to come."

CRISPR is a comparatively simple but powerful tool for editing genomes, which enables scientists to change DNA sequences and modify gene function. It has the potential to transform medicine and diagnose, treat and prevent many diseases, and has been used in developing diagnostic kits which may be used to detect infectious diseases such as Covid-19. The technology is estimated to be worth over $5 billion in the next five years.

The Broad Institute has been in a long-running battle over the ownership of rights in CRISPR with other institutions and researchers, including the University of California, Berkeley (UCB), led by professor of biochemistry Jennifer Doudna, the University of Vienna and French genetics professor Emmanuelle Charpentier, in both the EU and US. In October 2020, Charpentier and Doudna were awarded the Nobel Prize for Chemistry for their work on CRISPR.