UC Berkeley Appeals CRISPR-Cas9 PTAB Ruling
- Aug 17 2017 |
- Category: Blog
What is the status of the CRISPR patent dispute?
In February, this blog reported that the Patent Trial and Appeals Board (PTAB) ruled there was no interference in patents awarded to the Broad Institute of MIT and Harvard for its CRISP gene editing technology. The proceeding had been brought by scientists at the University of California at Berkeley.
This revolutionary technology snips away unwanted parts of genomes and replaces them with new sections of DNA.
Despite the PTAB ruling, the matter is still not settled. As many observers expected, Berkeley filed an appeal on April 12 in the U.S. Court of Appeals for the Federal Circuit in Washington, D.C. seeking to have the PTAB reinstate the interference.
An interference is a legal proceeding that had long been utilized to determine who was first to invent a particular technology. With the enactment of the America Invents Act in 2013, however, the U.S. shifted to a first-to-file system. Today, these disputes are currently handled in post-grant proceedings. In this case, Berkeley initiated the interference just a day before the AIA became effective.
The Disputed CRISPR Patents
In 2012, Berkeley’s team published a paper demonstrating the use of CRISPR-Cas9 gene editing in a bacterial system and applied for a patent on March 15, 2013. Six months later, the Broad Team filed a patent application for the use of CRISPR to edit animal cells. After paying for an expedited review, Broad was awarded a CRISPR patent in April 2014, even though Berkley filed first.
In April 2015, Berkeley petitioned the PTAB for the interference proceeding claiming they were the first to invent, but the panel’s ruling in February found that the patent claims were for distinct subject matter. In filing the appeal, Berkeley hopes to establish that its team was the first to engineer CRISPR-Cas9 for use not just in bacterial systems (where gene editing occurs naturally), but also in plant, animal, and human cells.
At this juncture, both the Berkeley and Broad teams have lucrative licensing agreements in place for their unique technologies, and both are pursuing additional patent applications. The question remains as to whether the appellate court will move to reinstate the interference or if the two parties will eventually reach a negotiated settlement.
Ultimately, hundreds of millions of dollars are at stake because of the potential commercial applications of the gene editing technology in the biomedical, pharmaceutical, and agricultural sectors. In the final analysis, patent disputes of this nature require the advice and counsel of experienced intellectual property attorneys.