Information about licensing CRISPR systems, including for clinical use

We are committed to making these technologies broadly available for research to help ensure that therapeutic development — bringing this technology to the clinic — has the best chance of success. We also consider important ethical,safety and societal concerns. (In particular, any human clinical use must be consistent with all laws and regulations, and we do not license the technology for clinical use of human germline editing.)
 

• For academic and non-profit research use, no written license is necessary. For these communities we make CRISPR tools, knowledge, methods and other IP for genome-editing freely available for research. Since February 2013, Addgene has shared more than 75,373 plasmids and reagents from the Zhang Lab with more than 3,268 institutions across 79 countries to help accelerate research into virtually every aspect of human health — including cancer, schizophrenia, diabetes, HIV and other infectious diseases. Non-profit institutions and government agencies do not need to receive a written license from Broad to conduct internal research, including sponsored research to the extent such research does not include the production or manufacture of products for sale or offer for sale or performance of commercial services for a fee. Further, non-profit institutions and government agencies may transfer materials they generate in the conduct of such internal research to other non-profit institutions or government agencies under the terms of the UBMTA (Uniform Biological Material Transfer Agreement) without needing to receive a further written license from Broad. (See below* for an example of sponsored research).
   
• For research by companies, we license CRISPR IP non-exclusively.
   
• For companies wishing to sell tools and reagents for genome editing, we also license CRISPR IP non-exclusively.
   
• For human therapeutics, we concluded that exclusivity is necessary to drive the level of investment needed to develop certain technologies to the point that they are safe, effective, and capable of precise editing in specific cell types.
   
  • Broad Institute, Harvard, and MIT therefore developed an approach that we call an “inclusive innovation” model. Under this model, Broad, Harvard, and MIT license CRISPR technology to a primary licensee. 
  • However, after an initial period, other companies may apply to license certain CRISPR IP for use against genes that are not being pursued by the primary licensee. 
  • Specifically:
    
    1. a third party interested in an individual gene target would provide a bona fide development plan,
    2. the primary licensee then has a predefined period to announce that it is already working on the target or to decide whether it intends to pursue the gene of interest and to commit funding and launch a program, and;
    3. if the primary licensee is not already working on the gene of interest and chooses not to launch a new program within this period, the IP may be available for licensing by Broad, Harvard, and MIT to the third party. 
  • The goal of our inclusive innovation model is to enable the primary licensee to devote sufficient investment to develop CRISPR-based genome editing technology to treat human diseases, while supporting broad development of medicines to reach many patients. 
  • To help enable such development, the Broad, Harvard, and MIT also retain rights to access certain human therapeutic targets for internal development and future licensing.
     

Broad has licensed various therapeutic and diagnostic technologies under the inclusive innovation model to multiple companies, including Editas Medicine, Beam Therapeutics, Prime Medicine and Sherlock Biosciences.

Parties interested in licensing under the inclusive innovation model are invited to contact partnering@broadinstitute.org.

*An Example of Sponsored Research:  As a non-limiting example, in keeping with Broad’s mission: research at a non-profit institution or government agency that is sponsored by a commercial entity will be considered sponsored research under this framework if it meets the following three criteria:

(i) the primary objective is to advance scientific, agricultural, livestock or medical research,

(ii) the non-profit institution or government agency plans to share its findings with the larger scientific community by publishing the results of such research and has that right, and

(iii) Title in any intellectual property rights created by the non-profit institution or government agency resulting from such research lies with the non-profit institution or government agency, who can practice under any and all such rights for internal research use.