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New decisions in Europe and the US in CRISPR/Cas9 patent dispute

23 March 2022

CRISPR/Cas technology, also known as “genetic scissor”, is one of the most targeted and promising tools in gene technology. It allows targeted and extremely precise modification of the DNA in humans, animals, plants and microorganisms. Therefore, it revolutionized genetic biotech as well as research.

It is expected that this method will provide substantial possibilities to fight back severe diseases such as autoimmune disorders and cancer as well as hereditary diseases like transthyretin amyloidosis (hATTR) or in the treatment of viral infections (e.g. HIV and hepatitis virus). 

Emmanuelle Charpentier and Jennifer A. Doudna were awarded the Nobel Prize in Chemistry 2020 for their discovery of the gene editing technique and the University of California (Berkeley) has filed several patents to protect this cutting-edge technology. On the other hand, the Broad Institute Inc. of the Massachusetts Institute of Technology (MIT) also filed patent applications for CRISPR/Cas related findings of Feng Zhang. 

Since then a long-running dispute around the CRISPR/Cas patents and the ownership of this revolutionary technology began and spread from the U.S. to Europe. 

European Opposition Proceedings 

One of the patents in dispute in the EU is EP 3 401 400 (EP’400). It protects “Methods and compositions for RNA-directed target DNA modification and for RNA-directed modulation of transcription”. EP’400 is one of the patents relating to Emmanuelle Charpentier, the Regents of the University of California as well as the University of Vienna, all of them being mentioned as applicants and proprietors of the patent.

Four opponents (including strawmen) had opposed EP’400 at the European Patent Office (EPO) claiming inter alia lack of novelty as well inventive step. It was also argued that neither interventions in the human germ line nor the commercial use of embryos were clearly excluded in EP’400, although this were required by the law. 

The oral hearing in the opposition proceedings started on 29 November 2021 and was adjourned on 1 December 2021 by the Opposition Division of the EPO (OD) until 21 February 2022. The OD was of the opinion that the main request and several auxiliary requests lacked novelty, while other auxiliary requests did not meet the requirements of Article 53(a) EPC. However, at the end of the hearing, the OD upheld the patent in amended form according to the auxiliary request 10 as filed on 1 December 2021. 

The amended claim 1 as upheld clarifies that the protected “method is not a process for modifying the germline genetic identity of human beings”, which addresses the arguments raised under Art. 53 EPC in accordance with Rule 28 (1) (b) of the Implementing Regulations to the Convention on the Grant of European Patents

U.S. Decision

The U.S. Patent and Trademark Office (USPTO) too has just decided one more case in the patent fight between the group around University of California on one hand and the group around the Broad Institute on the other. Also in this case, a number of CRISPR/Cas patents owned by the Regents of the University of California, the University of Vienna and Emmanuelle Charpentier were in dispute. 

Contrary to the OD, the USPTO found in its decision of 28 February 2022 certain claims “unpatentable under 35 U.S.C. § 102(g)”. The USPTO further held that the Broad Institute, Inc., the MIT and President and Fellows of Harvard College have priority over the Regents of the University of California, the University of Vienna, and Emmanuelle Charpentier “with respect to Count 1 – a single RNA CRISPR-Cas9 system that functions in eukaryotic cells”. That means the USPTO acknowledged – for now at least, since there will doubtless be appeals – that the Broad Institute and their scientists deserve recognition. 

Conclusion

The tremendous amount of documents filed during the opposition proceedings (more than 400 documents are included in the EPO file) shows that there is much more at stake than ethical principles. 

According to a Forbes press release, the business around CRISPR/Cas (tools) is worth billions of dollars. Publicly available information confirms that several companies are using CRISPR/Cas technology and tools already. Many of those companies have entered into licensing agreements and even a worldwide CRISPR-Cas9 licensing pool is discussed. 

With so much at stake, it can therefore be expected that the fight over the CRISPR/Cas will be continued and the decision of the OD will likely soon be appealed.