When police arrest a suspect, they are required to advise the suspect of his right to remain silent. A recent decision on CRISPR from the U.S. Court of Appeals for the Federal Circuit suggests that applicants for U.S. patents could also benefit from remaining silent.
Under U.S. patent law, a person is entitled to patent rights if the person invents a process, machine, article of manufacture, or composition of matter that is novel, useful, and non-obvious. In some situations, public statements made by an inventor may be used to thwart the inventor’s ability to patent their own invention.
CRISPR-Cas9 technology is a cost-effective and precise genome-editing tool that can be used to delete, modify, and replace genes in almost any type of cell. Cas9 is a CRISPR-associated endonuclease, a type of “molecular scissors” that can be programmed to cut and edit any segment of DNA. Once Cas9 makes a cut in DNA, that DNA can be deleted, modified, or replaced with a new segment of DNA using the cell’s own “repair” machinery.
Researchers have demonstrated in vitro that CRISPR can be used to correct genetic defects associated with various diseases. Recently, a Chinese scientist shocked the world when he claimed to have used CRISPR to engineer human babies who are immune to HIV virus. This technology is now being used to engineer plant and animal cells to produce useful products.
After the independent (and nearly simultaneous) discovery of commercially useful versions of CRISPR-Cas9 technology, the researchers behind the discovery — Dr. Doudna at UC Berkeley and Dr. Zhang at the Broad Institute — filed U.S. patent applications to protect their work. The co-pending U.S. patent applications before the USPTO triggered a dispute between them over patent scope that found its way to the Federal Circuit.
In September 2018, the Federal Circuit rendered a decision in favor of the Broad Institute by determining that its claims on the use of CRISPR in eukaryotic cells would not have been obvious over UC’s claims on the use of CRISPR generally. In reaching its decision, the Federal Circuit cited the following statements made by Dr. Doudna and her colleague:
- “Our 2012 paper was a big success, but there was a problem. We weren’t sure if CRISPR/Cas9 would work in eukaryotes”; “It was not known whether such a bacterial system would function in eukaryotic cells.”; “The techniques for making these modifications in animals and humans have been a huge bottleneck.”; “Although we’ve not yet demonstrated genome editing … it is now a very real possibility.” – Dr. Doudna.
- “There is no guarantee that Cas9 will work effectively on a chromatin target … remains to be seen.” – Dr. Carrol, Expert Witness of UC Berkeley.
In the end, the Federal Circuit sided with the Broad Institute on this pivotal CRISPR patent battle.
Given the Federal Circuit’s reliance on public statements made by UC Berkeley, one can only wonder what would have happened if the applicants for the UC patent had exercised their right to remain silent. For more information, please contact Tyler T. Cho, PhD, John J. Emanuele, PhD, or David L. Walker.