Licensing Gene Editing Systems

ӳý makes gene editing technologies — including CRISPR-Cas9, Cas12, Cas13, base editing, and prime editing — broadly available. Fields of licensing include internal research use, research tools development, agriculture, animal health, manufacturing, and bioproduction.

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 technologies for human germline editing.

Since 2014, ӳý has executed more than 200 non-exclusive gene editing licenses.

Academic and nonprofit research 

For academic and non-profit research use, no written license is necessary. For these communities, we make gene editing tools, knowledge, methods and other intellectual property for gene editing . Nonprofit institutions and government agencies do not need to receive a written license from ӳý 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, nonprofit institutions and government agencies may transfer materials they generate in the conduct of such internal research to other nonprofit institutions or government agencies under the terms of the UBMTA (Uniform Biological Material Transfer Agreement) without needing to receive a further written license from ӳý. (See below* for an example of sponsored research).

Translational research 

For research by companies, ӳý licenses gene editing IP non-exclusively in all fields other than therapeutics, including but not limited to internal research use by commercial entities, agriculture, therapeutics manufacturing, animal health, and commercial research tools. For example:

  • GenScript Biotech Corporation , Promega, Santa Cruz Biotechnology, Inc., Setsuro Tech, and Thermo Fisher Scientific each have non-exclusive licenses from ӳý to use CRISPR technologies to develop and sell CRISPR tools and services for research.
  • MilliporeSigma and ӳý offer a under their respective control for use in commercial research and product development.
  • Corteva Agriscience and ӳý jointly offer use in agricultural research and product development.

Human therapeutics development

For human therapeutics, we have 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.
 

  • ӳý, Harvard, and MIT have therefore developed an approach that we call an “inclusive innovation” model. Under this model, ӳý, 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 ӳý, 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 gene editing technology to treat human diseases, while supporting broad development of medicines to reach many patients. 
  • To help enable such development, the ӳý, Harvard, and MIT also retain rights to access certain human therapeutic targets for internal development and future licensing.
     

ӳý 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 (now OraSure).

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 ӳý’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.