The Patent War revolving around CRISPR

The CRISPR/Cas system was originally discovered by Nakata and his research group from Osaka University, Japan, in 1987 in prokaryotes. Thereafter, in 2012, the first attempts of in vitro gene editing attempts were documented. Numerous CRISPR/Cas systems and their variants have been discovered since then and have been applied for gene editing in different organisms.

Although initially, there were no disputes, later the realisation of the commercial potential of CRISPR/Cas led to an ugly legal battle over the intellectual property rights. Competing interests for academic credit, loyalty, personal profit, media attention, Nobel Prize dreams also became intense. The involvement of the respective universities (from where the researchers hailed) in the legal battle over intellectual property related to CRISPR/Cas9 further complicated the situation.

In June 2012, Jennifer Doudna, a molecular biologist from the University of California, Berkeley, and Emmanuelle Charpentier, then a professor at the University of Vienna, and now a professor at the Max Planck Institute for Infection Biology in Berlin published the first evidence that CRISPR/Cas9 system could be used to edit non-bacterial DNA. About 7 months later, George Church from the Harvard University and Feng Zhang from the Broad Institute published their own research to show that the CRISPR/Cas9 system could be used to edit the human genome. Subsequently, on December 12, 2012, the Broad Institute, and its collaborators, i.e., Harvard Institute, and Massachusetts Institute of Technology (the Broad team) filed a patent application for the use of CRISPR/Cas9 in plants and animal cells, and in April 2015, the Broad team received the first patent that they had applied for. This sparked a legal battle over the patent received by the Broad team and one that was applied by the University of California and the University of Vienna (the UC team) in May 2012 for the use of CRISPR/Cas9 in plants, animals, and human cells.

In 2016, U.S. Patent and Trademark Office (USPTO) initiated interference proceedings to determine whether the Broad team’s patent interferes with that of the UC team, and the Patent Trial and Appeal Board (PTAB) did not find any subsequent interference between both the patent claims. Later in May 2017, European Patent Office (EPO) granted the first EU patent to the UC team that would be applicable in the EU comprising of more than 35 countries for the use of CRISPR/Cas9 genome editing in plants, animals, and human cells.

However, this did not settle the dispute and the UC team appealed against the PTAB decision in July 2017. Thereafter, in February 2018, the UC team was granted a patent for the use of a version of the CRISPR tool that was easier to be used within any type of plant or animal cell or even outside a cell. In September 2018, the US Court of Appeals concluded that both the patents granted to the Broad team and UC team were separate. Nonetheless, the dispute continued. Subsequently, the UC team filed several patent applications related to the guide RNA that could be used along with Cas9 to cleave DNA at desired sites and also related to CRISPR-based suppression or activation of gene expression. The UC team was granted these US and EU patents.

On September 10, 2020, the PTAB ruled that the Broad team’s already granted patent had a priority over the use of the CRISPR system in eukaryotes, including lab-grown human cells or cells extracted from humans directly. In this major decision, PTAB also acknowledged the UC team’s role in CRISPR/Cas9 research and that CRISPR/Cas9 is an important component of the CRISPR genome editing tool kit. To date, a total of over 740 CRISPR patents have already been issued