NIH response to KEI request for NIH policy on on the licensing of federally-funded CRISPR patented inventions.

On June 6, 2017, KEI wrote to Dr. Thomas Price, Secretary of Health and Human Services (HHS), and Dr. Francis S. Collins, Director of the National Institutes of Health (NIH) requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions. A copy of our letter is available here: https://www.keionline.org/node/2801.

On June 21, 2017, we received an email from the NIH, with a response from Dr. Carrie Wolinetz, the Acting Chief of Staff and Associate Director for Science Policy at the NIH. Dr. Wolinetz said: "At this time, we do not believe that a new NIH policy to address the licensing of CRISPR patented technology is necessary."

June 21, 2017 Email from Lryic Jorgenson, (NIH/OD) [E]

to james.love, diane.singhroy, Andrews.goldman, Carrie

Dear Mr. Love, Ms. Singhroy and Mr. Goldman,

Please find below a response from Dr. Carrie Wolinetz, Acting Chief of Staff and Associate Director for Science Policy at the NIH, to your letter to Drs. Price and Collins requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions.

Lyric Jorgenson, PhD
Deputy Director, Office of Science Policy
National Institutes of Health
jorgensonla@od.nih.gov
301.496.6837

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Dear Mr. Love, Ms. Singhroy and Mr. Goldman:

Thank you for your June 6, 2017 correspondence to Dr. Thomas Price, Secretary of Health and Human Services (HHS), and Dr. Francis S. Collins, Director of the National Institutes of Health (NIH) requesting the HHS develop a policy on the licensing of federally-funded CRISPR patented inventions. The NIH reviewed the information you provided pertaining to the CRISPR technology as well as other information that is publicly available. You raise important issues regarding the licensing of NIH-funded patented technologies that have both research and clinical uses.

Among the benefits derived from NIH-conducted and supported biomedical research are effective and broadly accessible new healthcare treatments and services that benefit the public. Practical realization of these benefits depends on the ability and willingness of private sector partners to develop and commercialize new technologies arising from NIH-funded research. When NIH funding leads to a patented invention, NIH policies provide guidance to institutions licensing the patents to facilitate on-going scientific research with the patented technology and, at the same time, provide appropriate incentives for commercial development.

The relevant NIH policies are stated in Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources, December 23, 1999; https://grants.nih.gov/grants/intell-property_64FR72090.pdf. The principles are to: (1) ensure academic freedom and publication; (2) ensure appropriate implementation of the Bayh-Dole Act, which is incorporated into NIH’s funding agreements; (3) minimize administrative impediments to academic research; and; (4) ensure dissemination of resources that are developed with NIH funds. NIH guidelines and policies, which apply to all technologies including CRISPR, encourage patent owners to grant non-exclusive licenses to technologies developed with NIH funds whenever possible. In those cases where exclusive licensing is required to encourage development by private partners, exclusive licenses should be appropriately tailored to ensure expeditious development of as many aspects of the technology as possible and to ensure development of the technology in all research fields and product areas. NIH policies state that specific indications, fields of use, and territories should be limited to be commensurate with the abilities and commitment of licensees to expeditiously bring a technology to market, and further recites that no license program should prohibit continued research and innovation.

CRISPR-CAS9 technology is a foundational and broadly applicable platform technology that enables researchers to engage in scientific inquiry and companies to develop products and services that could benefit a broad range of patients. While there are ongoing legal proceedings regarding these patents and patent applications, the Broad Institute is a primary owner and licensor of patents on CRISPR-CAS9. According to the Broad Institute’s public statements found at https://www.broadinstitute.org/partnerships/office-strategic-alliances-a..., Broad, the Massachusetts Institute of Technology, and Harvard University (co-owners of the patents) have developed a licensing program to provide for broad access of the CRISPR-CAS9 technology to researchers and commercial developers. In summary, Broad’s and its partners’ licensing program for the CRISPR-CAS9 states: (1) tools, knowledge, methods and other intellectual property for genome-editing will be freely available to the academic and non-profit community; (2) non-exclusive licenses will be granted to companies to use CRISPR-CAS9 in their commercial research and to companies who will develop and sell research tools and reagents for genome editing; and, (3) for commercial development of human therapeutics that will require a significant level of investment, exclusive license requests for specific gene targets not otherwise under development will be considered. Broad reports that, since February 2013, more than 37,000 plasmids and reagents have been provided to more than 2,000 institutions across 59 countries.

Broad further explains that the technology will be licensed under a model that apparently has as its objective the efficient distribution of defined exclusive fields of use to commercial partners. Under this model, Broad, Harvard, and MIT have licensed their CRISPR technology to a primary licensee, Editas Medicine, Inc. (Editas) to exclusively use the technology on targets of its choosing for the development of genomic medicines. However, Broad retains some controls over sublicensing decisions by Editas to allow for the breadth of the technology to be exploited commercially. After an initial period, other companies may apply for commercial licenses to certain CRISPR patents for use against genes of interest not being actively pursued by Editas.

While we have not received any inquiries or complaints about lack of access to the CRISPR-CAS9 technology for research or commercial development from those who are in a position to use the technology, we continue to monitor access and use of the CRISPR technology that was funded by NIH with respect to public access and compliance with NIH principles and policies. At this time, we do not believe that a new NIH policy to address the licensing of CRISPR patented technology is necessary.

Sincerely,

Carrie D. Wolinetz, Ph.D.
Acting Chief of Staff and Associate Director for Science Policy
National Institutes of Health