Control of intellectual property covering the CRISPR/Cas9 (CRISPR) gene editing system continues to be hotly contested. CRISPR is a powerful technology as it takes advantage of a cell’s own machinery to allow precise gene editing in living cells and organisms. In August of this year, we reviewed the ongoing battle to obtain foundational patents to CRISPR in the United States between the University of California, Berkeley and the Broad Institute of MIT and Harvard. We also noted the revocation of one of the Broad Institute’s key CRISPR patents by the European Patent Office.
Most recently, on September 10, 2018, the United States Federal Court of Appeals upheld the United States Patent Trial and Appeal Board’s (PTAB) decision last year that the Broad Institute’s patent claims contained in multiple patents and one pending application to methods of editing genes in eukaryotic cells using CRISPR were valid. The University of California had argued that work by the Broad Institute inventors showing that the CRISPR system could be used in eukaryotic cells to modify DNA in vivo was obvious in view of claims to the use of CRISPR in the University of California’s earlier filed pending patent application. Prior to the Broad application, CRISPR had only been demonstrated in cell-free and prokaryotic systems. The Court of Appeals disagreed with the University of California, affirming the PTAB’s view that given the difference between prokaryotic and eukaryotic systems, a person of ordinary skill in the art would not have had a reasonable expectation of success in adapting CRISPR to eukaryotic cells. This debate was heard in the context of a patent interference, proceedings which are now obsolete under the current “first to file” system in the United States.
The Court of Appeals decision provides some clarity with respect to the validity and scope of the Broad Institute’s patent claims. However, the University of California remains free to pursue claims from their family of patent applications and it is difficult to predict what claims may ultimately issue from their applications. Further, an appeal of the European decision that revoked the Broad Institute’s patent based on an invalid priority claim relating to the naming of inventors is still pending.
Parties interested in the CRISPR licensing landscape are advised to monitor developments in this ongoing saga. Alternative gene-editing systems to CRISPR also continue to be advanced for those wishing to bypass the complexities of CRISPR IP altogether.