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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
The Patent Trial and Appeal Board ruled in favor of the Broad Institute, allowing the company to keep patents for their CRISPR-Cas9 gene-editing technology.
On Feb. 15, 2017, the United States Patent Trial and Appeal Board (PTAB) ruled in favor of the Broad Institute in the controversial dispute between the institution and the University of California, Berkeley over who has the rights to CRISPR-Cas9 gene-editing technology. In a 51-page decision, the PTAB concluded both party’s versions of the gene-editing technology focus on different uses for CRISPR and are, therefore, “patentably distinct.”
PTAB sided with the Broad Institute, who currently holds 13 of the 28 patents issued for CRISPR-Cas9. In the decision, PTAB said Broad’s claims focus on “CRISPR-Cas9 systems in a eukaryotic environment” while Berkeley’s “are all directed to CRISPR-Cas9 systems not restricted to any environment.” Berkeley claimed that the use of CRISPR-Cas9 in eukaryotic cells cannot be patented separately, while Broad asserted they are altogether separate inventions.
The battle over who has the rights to the gene-editing technology has been a long and tumultuous one for both parties. It began in May 2012 when Berkeley researcher Jennifer Doudna and Emmanuelle Charpentier, of the University of Vienna, filed for a patent for CRISPR-Cas9. The pair later published a paper on CRISPR in the journal Science. That same year Feng Zhang, a researcher from the Broad Institute, filed a provisional patent application, which was later accepted by the United States Patent and Trademark Office in 2014. In January 2016, Berkeley disputed the Broad Institute’s patents and the case heated up in August when an email from a former graduate student at the Broad Institute alleged Zhang read the Doudna/Charpentier paper prior to conducting his CRISPR-Cas9 research.
The PTAB decision means that for now, the Broad Institute will get to keep their respective CRISPR-Cas9 patents. For Berkeley, it means the school’s patent application for CRISPR-Cas9 in all types of cells and organisms may be “closer to issuance,” Berekeley said in a statement. The school said it disagreed with the court’s decision, but would also consider new legal challenges and the possibility of appealing the ruling. The Broad Institute said in a statement that it agreed with the court’s decision, and that “CRISPR should continue to be available to the global scientific community.”
The decision is good news for Editas Medicine, who licenses the gene-editing technology from the Broad Institute. The company saw a sharp increase in share price after the court decision was released. In contrast, the ruling is likely unfavorable for Caribou Biosciences, Intella Therapeutics, CRISPR Therapeutics, and ERS Genomics all of which license the technology from Berkeley and the University of Vienna.
Source: The Broad Institute, UC Berkeley, PTAB, Seeking Alpha