“USPTO Decision Shifts Control of Crispr-Cas9 Gene Editing Technology”
USPTO Decision Shifts Control of Crispr-Cas9 Gene Editing Patent
In a landmark decision on 28 February 2022, the US Patent and Trademark Office (USPTO) has potentially shifted control of the Crispr-Cas9 gene editing technology’s use in people away from its inventors, Emmanuelle Charpentier and Jennifer Doudna. This decision could have significant implications for companies looking to commercialize Crispr-Cas9 gene editing in treating disease, as they may now face the prospect of needing further, potentially expensive, patent licenses.
Details of the Patent Dispute
The decision relates specifically to the use of Crispr-Cas9 in eukaryotic cells, including those of plants and animals. The USPTO’s Patent Trial and Appeal Board (PTAB) decided that claims in 14 patent applications from Doudna and Charpentier’s group are unpatentable. This is because Feng Zhang’s team at the Broad Institute in Cambridge, US, had developed a system that worked in such cells first.
In 2012, Doudna and Charpentier’s team demonstrated, and initially patented, Crispr-Cas9 using isolated biochemicals, rather than in whole cells. Both they and Zhang’s group were working to extend the system into eukaryotic cells, and both filed patents in the US. When Zhang’s patent was granted, the UC Berkeley group attempted to invalidate it on the basis that it was an obvious extension of their patented, non-cell-based work. However, in 2017, the USPTO decided that because Zhang’s team specifically focused on eukaryotic cells, the inventions didn’t interfere and both patents could stand.
Priority Dates and Patent Rights
At the time, the USPTO assigned ‘priority dates’ for patent rights based on who was first to conceive a technology and deliver it, or ‘reduce it to practice’. In March 2013 it changed to assigning them based on who filed a patent application first. It assigned a 12 December 2012 priority date to the application from Zhang and the Broad Institute. UC Berkeley’s filings relating to Crispr-Cas9 in eukaryotes have a priority date of 28 January 2013. Therefore, if Zhang’s original patent stands, it takes priority over Doudna and Charpentier’s subsequent applications covering Crispr-Cas9 editing in cells.
Broad Implications of the Decision
As a result of the decision, the Broad Institute patent stands and the UC Berkeley group’s 14 patent applications ‘will not be granted’, UC Berkeley admitted in a statement. The group ‘has more than 40 issued US patents that were not involved’ in this process, covering all environments, including eukaryotic cells. ‘The 13 patents and one patent application owned by Broad remain under challenge,’ the statement adds. UC Berkeley is considering options to appeal this decision.
However, Jacob Sherkow, a biotech intellectual property expert at the University of Illinois at Urbana-Champaign, US, says that some of the UC Berkeley group’s patent claims may now be questioned. The decision will not affect academic researchers using Crispr-Cas9 technology much, Sherkow adds. That’s because the Broad Institute and UC Berkeley provide Crispr tools and some intellectual property freely for non-profit use.
Impact on Commercialisation of Crispr-Cas9
The Broad Institute’s priority for eukaryotic cell editing practically and financially affects companies commercialising Crispr-Cas9. Intellia Therapeutics and Crispr Therapeutics, who both have licences to the UC Berkeley’s patents, but not the Broad Institute’s, were likely seeking a different decision. ‘This decision really cements the need to get a licence from the Broad Institute to commercially develop Crispr-Cas9 products,’ Sherkow says. The Broad Institute would probably grant licences to both companies, as they are the farthest along among the major players in terms of clinical trials for Crispr-Cas9 therapies.
International Legal Battles Over Crispr-Cas9
While this latest decision is potentially significant, many legal battles over Crispr-Cas9 rage internationally. UC Berkeley and Broad are each also involved with ongoing proceedings against South Korean biotech company Toolgen, and separately also against multinational chemical supplier Sigma-Aldrich. Meanwhile, in Europe, UC Berkeley has benefited from a technical error that delayed the priority date for a key Broad Institute patent.
Despite the ongoing disputes, the evidence revealed in this decision dispels any doubt that Doudna and Charpentier’s team invented the basic Crispr-Cas9 technique. ‘It is almost philosophically impossible to get a clearer picture of the date and moment of conception of a monumental piece of technology,’ Sherkow says.