MilliporeSigma, a leader in genome editing, today announced that the United States Patent and Trademark Office has issued a formal notice allowing MilliporeSigma's patent application directed to its proxy-CRISPR technology.

"This is our first U.S. patent for CRISPR, and as a leading innovator of CRISPR technology, we will continue to collaborate with scientists around the world to ensure that the full potential of this powerful tool is realized, responsibly and ethically," said Udit Batra, CEO, MilliporeSigma. "This is great news for researchers in the U.S., as they now have more gene-editing options that accelerate drug development."

MilliporeSigma's proxy-CRISPR is a new genome-editing technique that makes CRISPR more efficient, flexible and specific by opening the genome for modification of DNA. The technology can help scientists modify regions of the genome which are difficult to access.

This U.S. patent allowance marks MilliporeSigma's 13th CRISPR patent worldwide. MilliporeSigma's CRISPR patent portfolio includes granted patents in AustraliaCanadaEuropeSingaporeChinaIsrael and South Korea. Those patents are for CRISPR-related technologies covering foundational and alternative genome-editing methods.

To deploy the method, two CRISPR systems are designed to target the genome in proximity to each other and work together. One CRISPR system opens a regional "door," pushing away blocking chromatin proteins, while the other walks through it to find the exact location for modification.  Since the resulting modification requires two CRISPR binding events, the proxy-CRISPR method can enable twice the specificity of individual CRISPR systems.

MilliporeSigma has received patents for its CRISPR paired nickase technology (cleaving opposite strands of a chromosomal sequence to create a double-stranded break) in AustraliaCanada and Europe. Patents for MilliporeSigma's CRISPR integration technology (chromosomal cutting of the sequence of eukaryotic cells and insertion of a DNA sequence) have been granted in AustraliaCanadaEuropeSingaporeChinaIsrael and South Korea. MilliporeSigma is licensing its entire patent portfolio for all fields of use.

CRISPR technology is a core competency for MilliporeSigma, which has 15 years' experience with genome editing, spanning from discovery to manufacturing. MilliporeSigma recognizes that genome editing has resulted in major advancements in biological research and medicine.  At the same time, the growing potential of genome-editing technologies has opened scientific, legal and societal concerns. MilliporeSigma supports research with genome editing under careful consideration of ethical and legal standards. MilliporeSigma's parent company, Merck KGaA, Darmstadt, Germany, has established an independent, external Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing, and has developed, defined and transparently published a clear operational position taking into account scientific and societal issues to inform promising therapeutic approaches for use in research and applications.