Wednesday, March 11, 2015

CRISPR is high profile in science, patents; competitor labeled a mere second comer

IPBiz has discussed the Solazyme and Nicolo matters wherein IP arrangements went bad.  The
Editas collaboration on CRISPR technology is another example of collaborative fallout.

The Scientist discusses CRISPR


CRISPR (clustered, regularly interspaced, short palindromic repeats) is named for particular DNA loci that are found in many archaea and bacteria. CRISPR works with associated nucleases, including Cas9, to protect the cells from viral infection by inserting short snippets of viral DNA into the CRISPR cassette. By combining the Cas9 nuclease with a short guide RNA that’s custom-designed to bind a specific target, CRISPR/Cas can easily edit any gene you want. Just in the past year, for example, it has allowed researchers to cure a rare liver disease in mice, to excise HIV-inserted genes from human immune cells, and to block HIV from entering blood stem cells. CRISPR/Cas is easier than the other nuclease-based editing technologies, says John Schimenti of Cornell University; scientists are basically a reagent catalog and a round of PCR away from having everything they need to utilize CRISPR.


MIT Tech Rev had addressed some of the patent issues


The control of the patents is crucial to several startups that together quickly raised more than $80 million to turn CRISPR into cures for devastating diseases. They include Editas Medicine and Intellia Therapeutics, both of Cambridge, Massachusetts. Companies expect that clinical trials could begin in as little as three years.
Zhang cofounded Editas Medicine, and this week the startup announced that it had licensed his patent from the Broad Institute. But Editas doesn’t have CRISPR sewn up. That’s because Doudna, a structural biologist at the University of California, Berkeley, was a cofounder of Editas, too. And since Zhang’s patent came out, she’s broken off with the company, and her intellectual property—in the form of her own pending patent—has been licensed to Intellia, a competing startup unveiled only last month. Making matters still more complicated, Charpentier sold her own rights in the same patent application to CRISPR Therapeutics.

The patent came as a shock to some. That was because Broad had paid extra to get it reviewed very quickly, in less than six months, and few knew it was coming. Along with the patent came more than 1,000 pages of documents. According to Zhang, Doudna’s predictions in her own earlier patent application that her discovery would work in humans was “mere conjecture” and that, instead, he was the first to show it, in a separate and “surprising” act of invention.

The patent documents have caused consternation. The scientific literature shows that several scientists managed to get CRISPR to work in human cells. In fact, its easy reproducibility in different organisms is the technology’s most exciting hallmark. That would suggest that, in patent terms, it was “obvious” that CRISPR would work in human cells, and that Zhang’s invention might not be worthy of its own patent.

Also, from The Independent, April 26, 2014:

Patent attorneys are now poring over the rival patent applications, in particular the claims relating to who has priority over a key element of the Crispr technique called Cas9, a bacterial gene for an enzyme that snips both strands of the DNA double helix at the same place - a key feature of the gene-editing process.

Professor Charpentier said that she identified Cas9, the most important discovery behind Crispr, when she worked at Umea University in Sweden, before she teamed up with Professor Doudna to co-author a scientific paper on Crispr-Cas9, published in August 2012.

Professor Charpentier, who is now at the Hannover Medical School in Germany, said that Cas9 was, in fact, described for the first time in an earlier scientific paper, published in Nature in March 2011, under its former name of Csn1.

"I was the scientist who described the technology and I kept the intellectual property when I was in Sweden??? Editas does not have access to the intellectual property of the patent where I'm the co-inventor," Professor Charpentier said.


From a press release in November 2014:

Cas9 can be programmed to use guide RNAs to target the protein to a specific sequence within double-stranded DNA, enabling simple, flexible targeting of nearly any site in a given genome. Caribou's technologies are based on research into the biology of CRISPR systems carried out by the Doudna Lab at the University of California, Berkeley, and their collaborators. At the core of Caribou's extensive CRISPR technologies IP portfolio is an exclusive license to the foundational CRISPR-Cas9 work from the University of California and the University of Vienna. This work was recently recognized by the award of a Breakthrough Prize to Caribou co-founder Jennifer Doudna, Investigator, Howard Hughes Medical Institute and Professor, U.C. Berkeley and her collaborator Emmanuelle Charpentier, Helmholtz Center for Infection Research and Umeå University.


From a press release in December 2014:


Editas Medicine, a leading genome editing company, today announced that they have entered into an exclusive joint license agreement with the Broad Institute of MIT and Harvard and Harvard University to access intellectual property and technology related to the CRISPR/Cas9 and TALE genome editing systems. The license allows broad utilization of the technology developed by Editas founders, Feng Zhang, Ph.D., of the Broad Institute, and George Church, Ph.D., and David R. Liu, Ph.D., both of Harvard University, for the prevention and treatment of human disease.

“Feng Zhang, George Church and David Liu are on the leading edge of the genomic medicine frontier, and it’s a privilege to work with them and to be allied with world-class institutions like the Broad and Harvard. We all share the goal of translating this cutting-edge science into breakthrough medicines for people with genetically-driven diseases,” said Katrine Bosley, chief executive officer, Editas Medicine. “At Editas, we are committed to broadly developing the science of genome editing, and we seek to fully enable the potential of the technology – through our own work and in collaboration with academic and industry partners.”

** US 8,945,839 issued on February 3, 2015. A "Track I" request had been made on 18 April 2014. A final rejection was issued on 18 Nov. 2014, with claims 1-28 rejected as anticipated over Jinek, WO'772 (later identified as Doudna). There was an issue of whether or not the priority documents to WO 2013/176772 supported the later disclosure. In this, there was an issue that the patent applicant had presented only arguments of counsel, with the examiner citing to In re Huang, 100 F.3d 136, 139 (CAFC 1996 ) and In re De Blauwe, 736 F.2d 699, 705 (CAFC 1984 ). Applicant brought up arguments made to the EPO about a Jinek journal publication, which were not of interest to the USPTO.
In a response filed 1 Dec. 2014, applicant was especially harsh to the Doudna application: "Doudna is nothing more than a mere 'second comer' and had no CRISPR-Cas invention prior to Feng Zhang."


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