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Right now there are three companies gearing up for an epic biotechnology legal showdown. At stake is nothing less than control over what promises to be the core tool of an entire industry for the next decade; one that may be used in everything from medicine to agriculture. The technology is CRISPR/Cas 9. An outgrowth of research on bacteria, this technology uses a bacterial protein (Cas 9) which can use short pieces of RNA (a single-stranded cousin of DNA) to guide itself to particular spots on the genome. In effect, CRISPR-based systems can be targeted with exquisite precision to where they are wanted and then used to perform a variety of tasks. CRISPR technology is so easy to use, and so good at what it did, that its use has spread like wildfire in scientific circles. Realising the commercial potential for the technology, its principal inventors have now started or joined companies determined to commercialise the technology. Two things are certain at this point. Firstly, the ownership of CRISPR and its related technologies will take a very long time to sort out. Secondly, and perhaps more importantly, is that a research group which values its funding is not going to wait for things to settle before forging ahead with advancements to what has already been hailed as the biotechnological breakthrough of the decade. As such, this case serves to highlight a strange paradox in modern biotechnology: that advances seem to come ever more quickly while the legal and regulatory responses to them lag further and further behind. In large part this is because of the nature of modern scientific research. It is now common for universities to demand that researchers produce inventions as well as publications. Equally, it is now much more common for researchers to work as part of large teams with members in multiple institutes. This, combined with the breakneck pressure to publish research (‘publish or perish’ having long since become standard operating procedure at research laboratories) leads almost inevitably to confusion when the time comes to determine who owns what. In the case of CRISPR/Cas9, Feng Zhang is the first of the parties to participate in the claim. Under the auspices of the Broad Institute, Zhang obtained a very broadly-worded patent on the use of CRISPR/Cas 9 technologies in April 2014. This was subsequently followed by a flurry of other CRISPR-related applications covering aspects of the same technology. Two other researchers; Jennifer Doudna and Emmanuelle Charpentier (both of whom hail from the University of California, Berkeley) have also stepped into the fray by licensing their portions of the intellectual property, generated in groundbreaking work on CRISPR, to other companies. These companies form a tangled web: Editas (which both Zhang and Doudna helped found), Intellia Therapeutics (which has now partnered with Caribou Biosciences, a company started by Doudna), and CRISPR Therapeutics (which Charpentier co-founded). And all of them, moreover, have good cause to consider that they are the ‘real’ owners of CRISPR. Complicating matters even further is the fact that the Broad Institute’s granted patent (with Zhang as the inventor) was obtained under the old first-to-invent laws governing U.S. patents. Also filed under the old laws is a still-pending application by the Berkeley group, with Doudna and Charpentier being listed among the inventors. Since then the U.S. has changed over to a first-to-file system under the new America Invents Act. As a consequence, the three-way fight over the rights to CRISPR will occur in a confusing legal space, with the old laws and mechanisms being applied in the context of new rules and processes. As of the time of writing, the first blow had been landed by the University of California (representing Doudna and Charpentier’s contributions), which has launched an interference application against ten of the Broad Group’s CRISPR patents. The nature of modern biotechnological research, along with the nature of Intellectual Property law and the complicated matters of ‘who owns what’ when researchers work across institution and country boundaries, all but ensures that there will be plenty of fights like the one surrounding CRISPR in the future. Publication Name: Legal responses lagging behind modern biotechnology Date: May, 2015

Thomas Gerard Schmidt

Candidate Attorney
Patent Department
Tel +27 11 324 3031

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