An epic East Coast, West Coast patent battle has been heating up about genetic technology that stands to change the biotech world. M.I.T. and Harvard have squared up against U.C. Berkeley and the Regents of California in disputes about ownership of the “CRISPR” technology. M.I.T and Harvard are aligned with the Broad Institute. U.C. Berkeley is teamed up with the University of Vienna.
The phrase CRISPR is an acronym for “clusters of regularly interspaced short palindromic repeats.” One could think of this technology as a genetic “cut and paste” tool that allows scientists to specifically cut out sections of DNA and replace them with modified nucleotide sequences. The technology uses bacterial enzymes to do the cutting. The technology is hugely promising, and genetic scientists all over the world are starting to use the therapies for a wide ranges of genetic modifications that run the gamut from agricultural improvements to crop strains, to gene therapies in humans for diseases such as cystic fibrosis, and even certain types of deafness. Other uses have been proposed for biofuel creation. Clinical trials on humans have been started on cancer related therapies, mostly in China.
Unfortunately, it’s not completely clear who to pay for permission to use the intellectual property. This is the crux of the battle—and the educational institutions are eager to rake in royalties from controlling the intellectual property.
A primary patent battle is going on at the Federal Circuit in the United States, but disputes are also underway in the European Union and China. A Federal Circuit appeal concerning the issuance of patents related to CRIPSR technology is currently under review. In a nutshell, credit for this breakthrough discovery is adamantly contested as the University of California and the University of Vienna continue to challenge CRISPR patents owned by the Broad Institute. University California Berkeley is claiming that the Broad Institute simply moved their already published CRIPSR system to mammalian cells, something that should have been rejected as “obvious” in light of Berkeley’s already pending application.
The legal battle began in 2014, when the University of California contested the issuance of Broad’s first patent related to mammalian cell use of CRISPR. The Patent Trial and Appeal Board ruled in favor of the Broad Institute in February 2017, sparking an appeal by Berkeley to the Federal Circuit. On appeal, Berkeley again argued that it was obvious for one the test the CRISPR system in eukaryotic cells, even though there was no guarantee that it would be successful – a point the PTAB relied on in its decision against Berkeley. The outcome of the appeal is still pending, but a decision will be produced in a matter of months.
Article by Nicole Sumida, J.D. candidate and John Buche, J.D. ©2018 Buche & Associates, P.C.