On June 12, 2018 – Berkeley was granted a patent on using CRISPR/Cas9 to edit single-stranded RNA. On June 19, 2018 – Berkeley was granted a second patent, covering the use of CRISPR-Cas9 gene editing with formats that will be particularly useful in developing human therapeutics and improvements in food security.
Reporter and Curator: Aviva Lev-Ari, PhD, RN
UPDATED on 6/6/2019
What is the future of CRISPR IP rights?
Most likely, a complex one. Genomic breakthroughs are on the rise as CRISPR unlocks the secrets of the human genome. The CRISPR-Cas9 IP battle seems settled for now. And there is no indication that Cas12a will kick up nearly the same kinds of patent fights. But that is no guarantee for the future. With a potential worth of billions of dollars, CRISPR has the capability to break scientific partnerships as easily as it does DNA.
The best way to stay out of the IP rabbit hole is to use CRISPR for research or non-profit purposes. But even commercial companies looking to build CRISPR-based platforms should carefully review the relevant licenses from each institution, especially as there are often non-exclusive options for certain kinds of CRISPR products and services. Unsurprisingly, the most complex CRISPR IP rights seem to center around therapeutics. But other industries including agriculture should be clear on their licensing options as well.
We are still in the early days of CRISPR technology and there is a lot to learn both in and out of the lab. The hope is that licensing CRISPR will become more straightforward or at least clearer and more organized. Synthego CSO Rich Stoner spoke with SynBioBeta’s Kevin Costa about the current atmosphere surrounding CRISPR IP rights. “Yes, there’s a lot of litigation and contention around the core patents. But the pace of innovation to create new nucleases, new ways to edit and more predictability means that we’re very optimistic about the future of the technologies we’re deploying now as well as over the next few years.”
But that future remains a little way off—the dust is still settling.
UPDATED on 3/2/2019
U.S. patent office indicates it will issue third CRISPR patent to UC
Patent involved in interference proceedings will add to university’s gene-editing portfolio
The U.S. Patent and Trademark Office has issued a notice of allowance for a University of California patent application covering systems and methods for using single molecule guide RNAs that, when combined with the Cas9 protein, create more efficient and effective ways for scientists to target and edit genes. U.S. patent application number 13/842,859, which had notably been examined in advance of a prior interference proceeding involving the Broad Institute, specifically focuses on methods and systems for modifying a target DNA molecule in any setting, both in vitro and within live cells, using one or multiple single guide RNAs, across every cell type. The associated patent is expected to issue in the next 6-9 weeks.
This CRISPR-Cas9 DNA-targeting technology, invented by Jennifer Doudna and Martin Jinek of the University of California, Berkeley, along with Emmanuelle Charpentier at Umea University and Krzystof Chylinski at the University of Vienna, is a fundamental molecular tool for editing genes. Together, this patent application and prior U.S. Patent Numbers 10,000,772 and 10,113,167, cover CRISPR-Cas9 methods and compositions useful as gene-editing scissors in any setting, including in vitro, as well as within live plant, animal and human cells.
“We are pleased the patent application is now allowed and that the issued patent will encompass the use of CRISPR-Cas9 technology in any cellular or non-cellular environment. We expect to see continued momentum in the expansion of UC’s CRISPR patent portfolio in the coming months,” said Eldora L. Ellison, Ph.D., lead patent strategist on CRISPR matters for the University of California and a director at Sterne, Kessler, Goldstein & Fox. “The steadfast protection of the CRISPR intellectual property pioneered by the Doudna-Charpentier team is wholly focused on the improvement of human welfare.”
The patent covers methods of using optimized guide RNA formats (including single guide and dual guide formats) in certain environments, including eukaryotic cells (such as human, animal and plant cells). The optimized formats modify the part of a guide RNA that interacts with the CRISPR/Cas9 nuclease.
Who is it that deserves credit for turning a bacterial immune system into a revolutionary gene editing tool?
We suggest that it is as follows: Two owners of IP in Red
Gene Editing Consortium of Biotech Companies: CRISPR Therapeutics $CRSP, Intellia Therapeutics $NTLA, Caribou Biosciences, ERS Genomics, UC, Berkeley (Doudna’s IP) and University of Vienna (Charpentier’s IP), is appealing the decision ruled that there was no interference between the two sides, to the U.S. Court of Appeals for the Federal Circuit, targeting patents from The Broad Institute.
Patents for the wide use of CRISPR-Cas9 for gene editing all types of cells have already been issued to the Doudna-Charpentier team by the European Patent Office (representing more than 30 countries), the United Kingdom, China, Japan, Australia, New Zealand, Mexico and other countries. The scope of the United States patent issued today broadly includes the use of a CRISPR-Cas9 compound that is specially engineered to be more easily employed inside any type of plant or animal cell, or outside a cell, in order to modify a gene or the expression of a gene.
CRISPR Therapeutics, Intellia Therapeutics and Caribou Biosciences issued the following joint statement on the grant of the ‘772 patent:
“We believe that the U.S. patent ‘772 granted today covers the use of CRISPR/Cas9 genome editing with the RNA guide formats that are widely used throughout the industry. We anticipate this is the first of many patents that will be granted to UC on this foundational CRISPR/Cas9 intellectual property.”
In addition to this granted U.S. patent, applications from this patent estate have been found allowable in the United States and also have issued in Europe, the United Kingdom, China, Japan and various other countries worldwide. These patents cover the dual- and single-guide RNA compositions of the widely adopted CRISPR/Cas9 genome editing technology and their uses in all environments, including plant, animal and human cells as well as for use in human therapeutics.
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Schematic representation of the CRISPR-Cas9 system. The Cas9 enzyme (orange) cuts the DNA (blue) in the location selected by the RNA (red). Image courtesy of Carlos Clarivan/Science Photo Library/NTB Scanpix
“Today’s patent is one of many we anticipate will be awarded to these inventors for their CRISPR-Cas9 invention,” said Edward Penhoet, special advisor to the UC Berkeley chancellor and special assistant to the University of California president. “Six years ago, the Doudna-Charpentier team was the first to file a patent application and publish on the necessary and sufficient components that enable CRISPR-Cas9 to be employed in all environments, including plant and animal cells. Their remarkable research has only accelerated since then, creating new jobs and opening up new possibilities to improve life.”
The U.S. patent granted today (10,000,772) is not involved in any interference proceeding before the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office, or any appeal before the U.S. Court of Appeals for the Federal Circuit. The ‘772 patent is not impacted by the USPTO’s decision to terminate an interference between a separate UC patent application and a patent application owned by the Broad Institute, Harvard University and the Massachusetts Institute of Technology without reaching a decision on which inventors were the first to invent the use of CRISPR/Cas9 technology for genome editing. UC’s appeal of that decision was heard on April 30, 2018 by the U.S. Court of Appeals for the Federal Circuit, which will issue a decision in the future.
RELATED INFORMATION
SOURCE
http://news.berkeley.edu/2018/06/19/doudna-charpentier-team-awarded-u-s-patent-for-crispr-cas9/
Comments made on On June 12, 2018 – Berkeley was granted a patent on using CRISPR/Cas9 to edit single-stranded RNA. On June 19, 2018 – Berkeley was granted a second patent, covering the use of CRISPR-Cas9 gene editing with formats
There have also been others commenting on the decision, including Jacob Sherkow, who’s an associate professor from the New York Law School. He said that he expected the second patent, in particular, to have “pretty minimal commercial value”. While former molecular biologist and biotech patent lawyer, Dr. Kevin Noonan have reportedly said he thinks UC Berkeley “is just happy to get a patent”.
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