MilliporeSigma and the Broad Institute of MIT and Harvard have agreed to offer non-exclusive licenses to CRISPR intellectual property (IP) for use in commercial research and product development. [MilliporeSigma]

MilliporeSigma and the Broad Institute of MIT and Harvard have agreed to offer non-exclusive licenses to CRISPR intellectual property (IP) for use in commercial research and product development.

Under the agreement, whose value and other financial terms were not disclosed, companies applying CRISPR in their research and development activities can license both sets of IP through the Broad Institute.

While each partner will control their own IP, the Broad institute plans to offer licenses to MilliporeSigma’s and Broad Institute’s CRISPR IP portfolios to potential licensees for internal research uses and for commercial research tools and kits.

MilliporeSigma and the Broad said their framework is designed to allow other key patent holders to participate in the future—either through this framework or via a third-party patent pool or collaboration—in order to further streamline non-exclusive access to key CRISPR technology.

“Together with the Broad Institute, we are simplifying the path to licensing CRISPR technology, which will make it more widely available to the global research and discovery community,” MilliporeSigma CEO Udit Batra, PhD, said in a statement issued Thursday by the partners. “Through this agreement, we will make it easier for our customers to be successful in their research that shortens drug development timelines for previously untreatable diseases.”

MilliporeSigma is the name through which the Life Science business of Merck KGaA, Darmstadt, Germany, operates in the U.S. and Canada.

Under the licensing framework, MilliporeSigma’s IP for CRISPR technology, offered under the Sigma-Aldrich portfolio brand, will become available royalty-free to non-profit academic institutions, non-profit business communities and governmental agencies for their internal research, consistent with the Broad Institute’s long-standing practice and requirements.

Ethical Considerations

The Broad and MilliporeSigma said that the licenses will follow their respective ethical licensing considerations, which exclude certain CRISPR technology applications, such as for any clinical human germline editing. Each entity can continue offering licenses independently, outside of the framework.

The Broad Institute outlines “institutional policies on IP licensing” on its website. Merck KGaA has established an independent, external Bioethics Advisory Panel to provide guidance for research in which MilliporeSigma and its other businesses are involved, including research on or using genome editing. Merck KGaA has also defined its operational position taking into account scientific and societal issues to inform promising therapeutic approaches for use in research and applications.

In addition to IP from Broad Institute and MilliporeSigma, the licensing framework includes certain Broad IP co-owned with multiple other institutions—including Harvard and MIT as well as the New York Genome Center, New York University, The Rockefeller University, the University of Iowa Research Foundation, the University of Tokyo, the Whitehead Institute for Biomedical Research and others.

Issi Rozen, chief business officer of the Broad Institute, noted in the statement that the Broad already licenses CRISPR non-exclusively for all applications, with the exception of human therapeutics.

“We are actively working to ensure the widest and simplest possible access to key CRISPR intellectual property,” Rozen said. “We believe that key CRISPR patent holders should come together to simplify and open up access, and this agreement is another example of a partnership that helps maximize and streamline access to these important scientific tools.”

In February, MilliporeSIgma was awarded its first CRISPR-related U.S. patent for its proxy-CRISPR technology, a new genome-editing technique designed to increase the efficiency, speed, flexibility, and specificity of CRISPR by opening the genome for modification of DNA. The technology can help scientists modify hard-to-access regions of the genome, according to MilliporeSigma.

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