The lawsuit is over
The discoverers of CRISPR/Cas9 were left without a patent for the technology in the USA
Polina Loseva, N+1
The US Patent Testing and Appeals Board has ruled on a dispute between the discoverers of the CRISPR/Cas9 system and those who adapted it to genome editing in human cells, a press release from the Broad Institute Statements and background on the CRISPR patent process reports. Now the patent for the use of this technology belongs to the Broad Institute, and not at all to those who were awarded the Nobel Prize for CRISPR/Cas9 in 2020. And this can become a huge problem for medical companies that have signed contracts with Nobel laureates.
"Genetic scissors" CRISPR/ Cas9 did not immediately appear in the arsenal of molecular biologists in the form in which they are used today. The history of their invention was formed in several stages.
In 2012, Jennifer A. Doudna from the Berkeley Institute of California and Emmanuelle Charpentier from the Max Planck Society Institute for Infectious Diseases discovered a virus protection system in bacteria: a system of repeats in the genome (CRISPR) and an enzyme that cuts viral DNA (Cas9). They also learned how to use this method in order to make changes to any place in the bacterial genome. And almost simultaneously with them, another group of scientists from Lithuania came to the same conclusions and results.
After that, both Dudna, Charpentier, and other researchers began to refine the CRISPR/Cas9 system so that it could be applied to eukaryotic cells, including human cells. The teams of George Church from Harvard University and Feng Zhang from the Massachusetts Institute of Technology were the first to do this in 2013.
When it became clear that the technology worked, biologists adopted it for various experimental tasks. And geneticists have thought about how it can be modified and begin to be used in medicine. But in order to register such improvements as a medicine, the permission of the inventor of the technology and the patent holder for it is necessary. And as to who should be considered the "father" of CRISPR/Cas9, the opinions of different instances differed.
Representatives of Dudna and Charpentier (or rather, the University of California, the University of Vienna and Emmanuel Charpentier personally) have registered a patent for a genome editing method. Representatives of Zhang and Church (or rather, the Broad Institute, which unites Harvard University and the Massachusetts Institute of Technology) received a patent for a method of editing the genome in eukaryotic cells.
In 2015, the side of Dudna and Charpentier stated that there is a conflict between these patents — the second technology, in their opinion, is part of the first. The European Patent Office agreed with this, so in Europe they are considered the holders of the patent for the CRISPR/Cas9 technology. But in the United States, the Board of Patent Trials and Appeals considered that genome editing in eukaryotes is a separate technology, and ruled in favor of Zhang and Church. Representatives of Dudna and Charpentier challenged this decision and, among other things, stated that Zhang had received some secret information about their developments and only thanks to this he was the first to debug editing in eukaryotic cells.
During the time that the proceedings were going on, the Nobel Committee announced its decision. Jennifer Dudna and Emmanuel Charpentier became laureates of the Chemistry Prize in 2020, while neither Lithuanian scientists nor employees of the Broad Institute were noted by the committee.
Now the Board of Patent Trials and Appeals has issued its verdict. According to him, the patent in the United States remains with the Broad Institute. This concludes the patent disputes, then the University of California, the University of Vienna and Emmanuel Charpentier can only file a complaint with the court.
The patent decision will affect not only the earnings of CRISPR/Cas9 "mothers", but also the budget of companies that use this technology. Those who have signed a contract with the Broad Institute benefit from this decision, and their shares are already growing. This is, in particular, the company Editas Medicine, which for the first time applied genome editing in humans in vivo. We talked about the fact that this method was used to treat vision loss in people, and in some patients it really got better.
Among the victims of the Council's decision are those who counted on a contract with the losing side. They will now have to negotiate and make a deal with the Broad Institute. This is, for example, CRISPR Therapeutics — this company is known for its first results against blood diseases, beta-thalassemia and sickle cell anemia. And Intellia Therapeutics — its employees were the first to test the introduction of the CRISPR/Cas9 system intravenously.
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