Gene therapy has been the promised land for a long time in biotechnology. More precise tools has been searched for as too be able to provide more precise tools and ultimately provided human gene therapies. A new tool based on a bacterial CRISPR-associated protein-9 nuclease (Cas9) from the bacteria Streptococcus pyogenes is now being applied in almost every major genetic research laboratory. It has a tremendous potential both as a research tool and to provide commercial applications.
The functions of CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) and CRISPR-associated (Cas) genes are essential in adaptive immunity in select bacteria, enabling the organisms to respond to and eliminate invading genetic material. Thus, the possibilities for this new tool is enormous as one continue to characterize the tool and develop usages. This new technology/tool is set to become a patent battleground as companies has started to position themselves over who will control the tool and its products.
According to a search in the patent database from Thomson Innovation there are currently 267 patent application comprising the CRISP-Cas9 technology. As can be observed from the statistics there are 3 major players sticking out who are currently trying to gain control over the IPR position when it comes to the new tool:
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Several organizations have filed both US and PCT (international) patent applications) However, Feng Zhang, a scientist at the Broad Institute at MIT, and his research team was the first to obtain a granted patent on the technique after submitting lab notebooks as prove they invented it first. Recently the University of California has asked the U.S. Patent & Trademark Office to decide who was first to invent the powerful gene-editing tool, CRISPR-Cas9.
But it is not only academic. Recently both Celgene, GSK and Novartis joined the battle. All fighting to get control over new therapeutic tool. In this press release the CRISPR Therapeutics launch were announced, based on the work by one of the original publisher of the tool. Shortly after the Zhang patent was issued, the Swiss biopharma firm CRISPR Therapeutics was established with a $25 million investment to leverage CRISPR-Cas9 technology developed by Emmanuelle Charpentier, a French visiting scientist at the at UCMR, Umeå University in Sweden which is also a professor at the Hannover Medical School in Germany. In Science in 2012 Jennifer Doudna at the University of California and Charpentier co-published for the first time the CRISPR-Cas9 and are now both backing new ventures. Charpentier claiming she has no obligations to UC Berkley so this ought to be interesting! Last November, Editas Medicine, which Feng Zhang at MIT co-founded, was launched with a $43 million investments. This has led to an emerging fight between the California/West Coast group and the Massachusetts/East Coast environment as well as between the pharma industries.
In the meantime, numerous firms, including Thermo Fisher Scientific's Life Technologies, Sigma-Aldrich, and Origene offer products based on the CRISPR-Cas9 system, and in lately also Taconic launched a CRISPR gene editing technology for mouse and rat models after securing a license from the Broad for Zhang's technology.
The golden question will be the control positions. Ownership of the intellectual property behind the CRISPR-Cas9 technology is clearly inducing a major patent fight between the most prominent scientists in the field as indicated above as well as the pharma industry. Neither, MIT, Harvard or UC Berkley are known to avoid picking a fight. Who will obtain the financial rewards if CRISPR revolutionizes the pharmaceutical industry and launches a new era of human medicine? The single institution, the pharma industry, both or the actual individual user of new therapeutic products? This remains to be seen.
Knut J. Egelie
IPIN - Intellectual Property Institute of Norway