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Special report: The CRISPR/Cas 9 patent battle

Charpentier and Doudna

In 2012 two scientists, Jennifer Doudna at the University of California, Berkeley, and Emmanuelle Charpentier at the University of Vienna and the University of Umeå, published their ground-breaking findings about the mechanisms behind the CRISPR/Cas 9 system.

Text by Pia Andrea

Although Jennifer Doudna and Emmanuelle Charpentier were the first to discover, and also the first to apply for a patent on the CRISPR/Cas 9 system, they found themselves outflanked by the scientist Feng Zhang at MIT, Broad Institute, who quickly after handing in his patent application was granted a patent for CRISPR/Cas 9. The subsequent patent battle was extended and appealed at several levels.

“In Doudna’s and Charpentier’s published article from 2012 it is presented how the CRISPR/Cas 9 system works in certain bacteria. They predicted that CRISPR/Cas 9 could be used for gene editing, but the article only shows how the system works in bacteria. They showed how bacteria are using this system to defend themselves against foreign DNA, for example from different viruses,” says Linus Plym Forshell, Patent Engineer and Information Specialist at the Swedish Patent and Registration Office (PRV).

Bacteria vs more complex organisms

On March 15, 2013 Doudna and Charpentier filed a patent application in the U.S. for the CRISPR/Cas 9 system as a tool for gene editing. But Zhang also filed a patent application in the U.S. during 2013. Feng’s application was approved in April 15 2014. Doudna and Charpentier opposed the decision, since they had filed their application seven months earlier than Zhang, and they considered that they were the first to apply for a patent on the CRISPR/Cas 9 system.

“When someone objects to a granted patent an investigation is made by the responsible patent authority,” explains Plym Forshell. “So the U.S. patent authority, USPTO, initiated an investigation to throw light on how the different patent applications differed from one another and if Doudna’s and Charpentier’s patent application somehow was an obstacle for Zhang’s application and approved patent. In that investigation they concluded that Doudna’s and Charpentier’s application seeks protection for the CRISPR/Cas 9 system itself but it is not limited to a specific organism that the system could work in.

“They showed that it worked in bacteria, in the natural system, but it is a completely different thing to make it work in more complex organisms,” says Plym Forshell.

USPTO’s ruling was that at the time of Zhang’s patent application there was nothing else that with conviction could show that CRISPR/Cas 9 would work in more complex organisms. Doudna and Charpentier had not shown that. Zhang on the other hand had shown how the system works in more complex organisms, such as plants and animals, and thereby he was granted the patent for that.

Great commercial interest

So the USPTO rejected Doudna’s and Charpentier’s objection and Zhang got to keep his patent. They appealed the decision to the next authority, the U.S. Court of Appeals for the Federal Circuit. An investigation of USPTO’s judgement was performed and they found that the USPTO had reached a correct verdict, so this authority also rejected the objection against Zhang’s approved patent.

“There is a great commercial interest in this discovery and today both Doudna and Charpentier, as well as Zhang, hold several patents in many different countries. Large international companies have paid licenses to be able to use the technology in these patents. When we at PRV a couple of years ago did business intelligence research on the patents around the CRISPR/Cas system we noticed that already, since the start in 2013, this field of technology has grown explosively and it will probably continue. This is a revolution within gene technology that provides possibilities to among other things cure diseases and alter plants so that they are more resistant. But as with all gene technology it is a question of morals and ethics, which could limit what we in the end will have permission to perform with this technique, regardless of if you have a patent or not,” concludes Plym Forshell.

Facts

CRISPR/Cas9 is a machinery that naturally occurs inside certain bacteria. Its purpose is to destroy foreign DNA chains, for example virus DNA. This discovery enables possibilities to change the DNA of organisms. This was a revolution within genetic engineering and the discovery could someday be awarded a Nobel Prize.

Photo of Emmanuelle Charpentier (left): Hallbauer&Fioretti. Photo of Jennifer Doudna (right): Wikipedia

 

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