EPO to Grant Historic CRISPR Patent
A model of the Cas9 protein cutting a double-stranded piece of DNA. Credit UC Berkeley
The European Patent Office (EPO) has announced its intention to grant a broad patent for the revolutionary CRISPR-Cas9 gene-editing technology to the University of California, the University of Vienna and Emmanuelle Charpentier.
“The university is thrilled with this important EPO decision, which recognizes the pioneering work of Jennifer Doudna, Emmanuelle Charpentier and their teams as the CRISPR-Cas9 inventors, and also recognizes that the original patent application covers a wide range of cell types, including human cells,” said Edward Penhoet, who was recently appointed a special advisor on CRISPR to the UC president and UC Berkeley chancellor. Penhoet, the cofounder and former CEO of Chiron Corp., is the associate dean of biology at UC Berkeley and a professor emeritus of molecular and cell biology.
The EPO patent will cover the single-guide CRISPR-Cas9 technology in cells of all types. The technology was invented by Jennifer Doudna, a UC Berkeley professor of molecular and cell biology, Charpentier, now director of the Max Planck Institute for Infection Biology in Berlin, and their colleagues. Applications include treatment of various human diseases, as well as veterinary, agricultural and other biotech applications. The European patent would cover some 40 countries, including France, Germany, Italy, Spain, the Netherlands and Switzerland.
The EPO has stated its intent to grant a patent with claims that encompass all cells, despite objections from third parties, including the Broad Institute, a joint research institute of Harvard University and the Massachusetts Institute of Technology.
“We are excited that this patent will issue based on the foundational research we published with Emmanuelle Charpentier and the rest of our team. We look forward to the continued applications of gene-editing technology to solve problems in human health and agriculture,” said Doudna, who is a Howard Hughes Medical investigator at UC Berkeley.
The CRISPR-Cas9 tool allows the precise editing of genes, and has been used in thousands of laboratories around the world to target and cut desired sequences of DNA, analogous to cutting and pasting letters or words with a word processor. This technology has already revolutionized the study of genetic diseases, and has spawned promising new therapies for blood diseases, AIDS and cancer.
The EPO’s notice of intent to issue the patent, as well as the UK Intellectual Property Office’s grant of two similarly broad patents, are precedents for Doudna and Charpentier to receive wide-ranging patents in many countries, since many look to EPO and UK decisions for guidance in granting patents.
The UC patent application to the EPO was substantially the same as the UC patent application filed in the United States. In the U.S., UC claims covering the use of single-guide CRISPR-Cas9 technology in any setting were found to be allowable by the U.S. Patent & Trademark Office, and were placed in an interference with patents owned by the Broad Institute that cover use of the technology in eukaryotic cells. An interference is a formal legal proceeding before the Patent Trial and Appeal Board (PTAB) to determine who was the first to invent.
In a February ruling, the PTAB terminated the interference between the UC application and Broad patents, determining that the claims of the two parties did not constitute the same invention and, accordingly, the PTAB did not determine which party first invented the use of the technology in eukaryotic cells.
“We disagree with the recent PTAB decision to terminate the interference between claims of the UC and the Broad Institute, and we are keeping all of our options open, including the possibility of an appeal,” Penhoet said. “We remain confident that when the inventorship question is finally answered, the Doudna and Charpentier teams will prevail.”