CRISPR has changed the gene-editing landscape, and there are big questions being debated, explains Melanie Hardman, Founder of Ximbio,
On both sides of the Atlantic, patent lawyers are debating who should have intellectual property rights over the most exciting and most flexible gene-editing technique yet devised for eukaryotic DNA.
The CRISPR/Cas9 system (Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR associated nucleases) is a type of immune-response mechanism used by some archaea and bacteria.
Nearly three decades of research since Yoshizumi Ishino at Osaka University first cloned part of a CRISPR in 1987 (while working on a different gene) has led to its development as a tool for the genetic engineering of higher organisms.
In February 2017, the US Patent and Trademark Office (USPTO) ruled that the University of California, Berkeley, had only limited rights to the invention and that a separate patent from the Broad Institute of Harvard and MIT in Cambridge, Massachusetts, was also valid. But this has not settled the affair: UC Berkeley promptly appealed, so the case will continue.
In Europe, because of differences in the law and in its interpretation, the European Patent Office came to a different conclusion from the USPTO and granted a broad patent to UC Berkeley and co-applicants. It is anticipated the Broad Institute will challenge the decision. And the debate may well continue for another five years or more.
For researchers who just want to get on with their science, CRISPR is a tool that makes gene editing faster and easier. For example, cancer researchers are using CRISPR to edit cell line genomes to determine disease-causing mutations.
For Ximbio, it could mean many more cell lines and mice being deposited with us, providing tools that will open up exciting new lines of research. Ximbio exists to search, source and share reagents within the life sciences and specialises in cell lines, as well as antibodies, mouse models, plasmids, small molecules and other research tools.
CRISPR has rapidly occupied a large niche compared to genome editing techniques such as traditional homologous recombination, zinc finger nucleases and transcription activator-like effector nucleases (TALEN).
Isobel Atkin, a senior portfolio manager at Ximbio, welcomes the idea that some of the techniques she’s mastered during her career may become redundant as a result of CRISPR. ‘It’s quick and targeted, like a fast-forward shortcut,’ she said, as she recalled the many laborious steps involved in making a GFP (green fluorescent protein) tagged knock-out herpes virus as part of one project she worked on in the past.
CRISPR allows researchers to knock-out or to transfer genes with greater ease and speed. Plus more recent developments of CRISPR also allow site-specific genomic control, including both transcriptional and epigenetic regulation.
CRISPR tool-kits are commercially available, with the companies who make and market the kits dealing with the patent licencing issues - even though the lawyers are still debating intellectual property rights.
Ximbio is not a patent agent and cannot offer legal advice on intellectual property, but we do carry out due diligence on cell lines and the other reagents that are deposited with us to make sure appropriate licenses for third party IP are in place. And, of course, monies generated when we successfully commercialise research tools are shared with the depositors, providing them with some financial return.
Passing on the task of maintaining and distributing such material to Ximbio allows researchers to concentrate on their research, rather than worrying about the best route for commercialisation or having to respond to other users’ requests for the material.
With CRISPR leading to the generation of many, many more cell lines, mice and other research tools, Ximbio will have the opportunity to increase volume of new research tools and ensure that all reagents are properly characterised and maintained.
Furthermore, as CRISPR is relatively quick and accessible, will researchers prefer to generate their own research tools using CRISPR themselves, rather than acquiring pre-edited tools generated by other researchers using CRISPR?
Look out for more on this in a future blog…
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