The European Patent Office (EPO) has told MilliporeSigma it intends to grant approval of its patent application covering the company's CRISPR technology used in a genomic integration method for eukaryotic cells—the second key patent awarded in Europe covering the gene-editing technology.

MilliporeSigma, the life science business of Merck KGaA, said the EPO has issued a “Notice of Intention to Grant” a broad patent for the company’s CRISPR (clustered regularly interspaced short palindromic repeats) genomic integration technology.

The patent would be along the lines of one awarded to MilliporeSigma in Australia in June. That patent covers chromosomal integration or cutting of the chromosomal sequence of eukaryotic cells and insertion of an external or donor DNA sequence into those cells using CRISPR.

“The present invention provides RNA-guided endonucleases, which are engineered for expression in eukaryotic cells or embryos, and methods of using the RNA-guided endonuclease for targeted genome modification in eukaryotic cells or embryos,” according to an abstract of the patent to be granted, EP3138910, entitled “CRISPR-based Genome Modification and Regulation.”

“Also provided are fusion proteins, wherein each fusion protein comprises a CRISPR/Cas-like protein or fragment thereof and an effector domain. The effector domain can be a cleavage domain, an epigenetic modification domain, a transcriptional activation domain, or a transcriptional repressor domain,” the abstract added. “Also provided are methods for using the fusion proteins to modify a chromosomal sequence or regulate expression of a chromosomal sequence.”

MilliporeSigma says the CRISPR genomic integration technology is designed to enable researchers to replace a disease-associated mutation with a beneficial or functional sequence, a method important for creation of disease models and gene therapy.

“Significant and Exciting”

“This is a significant and exciting decision by the EPO, and we view this announcement as recognition of MilliporeSigma's important contributions to the genome-editing field,” MilliporeSigma CEO Udit Batra, Ph.D., said. “This patent provides protection for our CRISPR technology, which will give scientists the ability to advance treatment options for the toughest medical challenges we face today.”

MilliporeSigma also predicted that it would be awarded patents for the technology in other countries as well.

The European patent to MilliporeSigma comes five months after the EPO announced an “intention to grant a patent” broadly covering CRISPR technology to Emmanuelle Charpentier, Ph.D., a director at the Max-Planck Institute in Berlin, together with the University of California (UC), and University of Vienna.

The patent consisted of broad claims directed to the CRISPR/Cas9 single-guide gene-editing system for uses in both noncellular and cellular settings, including in cells from vertebrate animals such as human or mammalian cells—as well as composition claims for use in any setting, including claims for use in a method of therapeutic treatment of a patient. The technology has been licensed to companies that include CRISPR Therapeutics—whose co-founders include Dr. Charpentier—and ERS Genomics, both of which announced the EPO decision.

Dr. Charpentier, UC, and University of Vienna are in a legal battle royal with the Broad Institute of MIT and Harvard over who invented the gene-editing platform. Late last month, the European patent holders filed a brief with the U.S. Court of Appeals for the Federal Circuit seeking to reverse the February 15 decision by the Patent Trial and Appeal Board (PTAB). The PTAB found “no interference in fact” between 12 patents related to CRISPR technology that list as inventor Feng Zhang, Ph.D., of the Broad, and a patent application by Dr. Charpentier and Jennifer Doudna, Ph.D., of UC Berkeley.

“The #CRISPR #patent situation in Europe just got a LOT more complicated,” tweeted Jacob S. Sherkow, J.D., associate professor at the Innovation Center for Law and Technology, New York Law School, who has closely followed the CRISPR legal wrangle, on August 5.

Until now, he tweeted, the EPO granting of a patent to Dr. Charpentier, UC, and the University of Vienna “didn't mean Zhang couldn't get his. Now, it's unclear.”

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