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“More haste less speed” doesn’t work for patents
Written by: Hanna Fleisher

Dear friends, we continue the series of posts about the breakthrough CRISPR-Cas9 technology. This time we focused on the judicial aspect and, to begin with, we will recall the background.

The pioneers of CRISPR-Cas9 are two teams: Emmanuelle Charpentier and Jennifer Doudna with their institutes and subsidiaries, including CVC, and Feng Zhang with its affiliates, including the Broad Institute. Moreover, Charpentier and Daudna conducted research on the CRISPR-Cas9 system on prokaryotes, and Zhang – on eukaryotes. Although prokaryotic cells were the subject of the study, CVC’s patent applications attempted to obtain the broadest possible monopoly, so they covered all cell types – eukaryotic cells including. In contrast, the Broad Institute limited oneself only to the real research objects – eukaryotes. Therefore, for a long time there has been a patent battle between CVC and the Broad Institute for the right to use the CRISPR-Cas9 system in eukaryotic cells, during which CVC tried, firstly, to prove the obviousness of using CRISPR-Cas9 in eukaryotes, and, secondly, to demonstrate evidence that they had been already investigating CRISPR-Cas9 in this type of the cells before the filing date of the competitive application.

In the case of CVC vs. Broad the right of priority remains with the party that first provides the practical implementation of the invention. Therefore, during the trial, CVC had to give evidence of the practical implementation of those aspects of the invention that relate to eukaryotes. Namely, not only to conduct the experimental work, but also to show that it was successful. At this stage, CVC was not able to provide convincing material.

Specifically, on June 28, 2012, Dr. Florian Raible, who at that time was the head of the research group at the Center for Molecular Biology at the University of Vienna, sent a letter to Dr. Emmanuelle Charpentier, in which he expressed his interest in CRISPR technology and its approbation in fish models, in particular in vivo (i.e., inside a living organism). On June 29, 2012, Dr. Jennifer Doudna approved the experiment.

The essence of the study was to edit the rx3 gene, which is responsible for the formation of the eyes, because it was known that mutations in the rx3 gene give a specific phenotype of eyeless fish.

In July 2012, the first experiment was conducted, that did not give the expected phenotype, but the second experiment, conducted a month later, was more successful. So to speak, only one embryo out of 30 (!) showed a phenotype without the eyes. Florian Raible presented the results at several exhibitions and was positive – the experiment with fish showed that there was a successful site-specific cleavage of DNA in the zygote, which was introduced with the CRISPR-Cas9 system.

Florian also shared his results with Dr. Chilinski, who, in turn, forwarded them, with his commentary, to Dr. Charpentier on August 9, 2012. It was in Dr. Chilinski comment that representatives of the Broad Institute found a loophole, which they emphasized in their subsequent defense. There is no point in quoting the letter in full, but note that Dr. Chilinski used cautionary terms such as “potentially good news,” “there is a hint that it might work,” and “not to get too excited.” In addition to the fact that Dr. Chilinski openly did not call the experiment a success, he also noted that the object was Medaka fish, not Danio. In general, many materials were still considered and passionate discussions were conducted, which led to one result – CVC failed to prove that by 12.12.2012 (the filing date of the competing patent application) they were able to conduct successful experiments with the CRISPR-Cas9 system on eukaryotes.

So, dear scientists, the saying “more haste less speed”, as we can see, does not always work in a positive direction.

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