Marshall Lerner, managing partner, and Daniel Malkin PhD, an associate, delivered in February 2022 a presentation to a group of undergraduate, doctoral, and postdoctoral students in the Chemistry Department of Harvard University about the CRISPR patent litigation and the use of CRISPR in eukaryotic cells. The litigation is between UC Berkeley and the Broad Institute of MIT and Harvard. Mr. Lerner did a presentation in 2018 on the first round of litigation in the Patent and Trademark Office and a follow-up presentation on February 11, 2019, after the Patent and Trademark Office decision was affirmed on appeal. He delivered a follow-up presentation in February 2020 which discussed the litigation and in February 2021 delivered a presentation regarding the current status of the second round of litigation between the parties. Both Mr. Lerner and Dr. Malkin discussed some of the bioethical issues pertaining to CRISPR technology
A CRISPR-Cas9 system is a combination of protein and ribonucleic acid (“RNA”) that can alter the genetic sequence of an organism. In their natural environment, CRISPR-Cas systems protect bacteria against viral infections. The CRISPR-Cas9 system is now being developed as a powerful tool to modify specific deoxyribonucleic acid (“DNA”) in the genomes of other organisms, from plants to animals. With CRISPR, scientists can create mouse models of human diseases much more quickly than before, study individual genes much faster, and easily change multiple genes in cells at once to study their interactions. It has been used in labs to correct for the mutation that causes sickle-cell anemia, create mosquitoes that can fight malaria in their bodies, and make crops more resistant to disease and drought.
The litigation was to determine the owner of the patent rights to the basic CRISPR technology to be used in eukaryotic cells. UC Berkeley invented the basic CRISPR technology. Broad obtained a patent on the basic CRISPR technology in combination with eukaryotic cells, the more valuable application of CRISPR. The first litigation was an interference proceeding to determine who first invented the basic CRISPR invention in combination with eukaryotic cells. The UC application was filed prior to the change in the patent statute of March 2013, and therefore, priority was awarded based on first to invent (rather than first to file under the new statute). UC Berkeley argued that the use of CRISPR in combination with eukaryotic cells was an obvious variation of the basic invention of CRISPR. Therefore, UC Berkeley maintained that it owned the patent rights to the basic CRISPR technology in combination with eukaryotic cells which was the patent rights asserted in the Broad patent. The Patent and Trademark Office held in the first litigation that the invention of CRISPR in combination with eukaryotic cells was a novel and nonobvious improvement over the basic CRISPR invention, and therefore, there was no interference because the inventions of the two parties were patently distinct. UC Berkeley then filed applications claiming CRISPR in combination with eukaryotic cells, and the Patent and Trademark Office declared a second interference proceeding to address the issue of who first invented CRISPR in combination with eukaryotic cells. The Patent and Trademark Office has since held in favor of Broad in the second interference, and an appeal by UC Berkeley is anticipated.
Mr. Lerner and Dr. Malkin also discussed some of the bioethical issues pertaining to the use of CRISPR technology. Recently there have been some uses of the CRISPR technology, particularly in China, which raise significant bioethical issues. Mr. Lerner discussed these issues and some of the ultimate implications.