Attached (PDF file here) are the KEI comments on the proposed NIH exclusive license to miRecule for MicroRNA Therapeutics for Treating Squamous Cell Carcinomas.
The seven page letter concludes with these words:
KEI recognizes that in cases where a technology requires significant investments to achieve practical application of the invention, the use on an exclusive license may be justified. KEI is asking the NIH to include in the license provisions protecting the public from abuses of those exclusive rights. The NIH is also asked to recognize and address the public’s interest in limiting the scope and the length of the monopoly to that which is reasonably necessary.
When the NIH licenses patents to a firm with limited resources, such as miRecule, and indeed to any firm, the license should contain sufficient obligations to work the patent, and specifically to ensure that the exclusive rights granted in a license do not impede the timely development of a promising technology by others when the license holder fails to achieve timely practical application of the technology.
KEI also notes that the license is being offered to a former NIH employee. In cases where the NIH is offering a license to a former employee, it has a responsibility to ensure (1) the licensing negotiations are as transparent as possible, and (2) that the terms include sufficient public interest safeguards.
On August 22, 2017, the NIH responded with this letter.
This is now the NIH addressed our questions about the practice of licensing patents to former NIH employees:
With regards to the company founder being a former NIH investigator and co-inventor of the patent estate his start- up company seeks to license, we have already addressed all questions of potential conflict. Dr. Saleh terminated his employment at NIH prior to starting miRecule and he will take no part in direct negotiations of any license.
This was the NIH refusing to provide a copy of the CRADA.
Dr. Saleh will have direct participation in the research under his company’s Cooperative Research and Development Agreement (CRADA) with the National Institute on Deafness and Other Communication Disorders (NIDCD) in order to advance the technology since a positive research outcome under the CRADA is one stepcloser to the development of a successful therapeutic to at least one squamous cell carcinoma. With respect to your request for various reports including CRADA documents, it is not consistent with our mission to create reports requested by the public and the proprietary content of the agreement governing the CRADA between the NIDCD is strictly confidential. In summary, the CRADA research plan sets forth a joint effort between miRecule and NIDCD to develop chemically modified mimic or mimetic microRNAs that are stable and less susceptible to nuclease degradation than previously identified microRNAs and that serve as therapeutics for cancer when delivered using tumor targeted nanoparticles. The CRADA will test these microRNAs in animal cancer models to evaluate their efficacy and the pharmaceutical properties of candidate formulations.
If your organization requests more documentation, such requests should be filed under the Freedom of Information Act. The webpage for the NIH FOIA Office provides more information on filing requests