(Update: The NIH has provided a response to our comments on August 31, 2020)
On August 28, 2020, Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT) submitted comments to the National Institutes of Health (NIH) “Prospective Grant of an Exclusive Start-Up Patent License for Evaluation: Immunotherapy for Relapsed/Refractory Diffuse Large B Cell Lymphoma” (85 FR 49387). The technology to be licensed is an immunotherapy against relapsed or refractory diffuse large B cell lymphoma, specifically the patent estates, “cover methods of treating a subject with a tumor by administering transgenically modified adoptive NK (natural killer cells), methods of generating transgenic NK cells, and transgenic NK cells per se.”
The licensed is to be granted on a worldwide, exclusive basis to ONK Therapeutics, a firm located in Ireland. Considering that this technology is financed by U.S. taxpayers, and that the company to receive the license is foreign-owned and operated, how will the NIH address and enforce the Bayh-Dole U.S. manufacturing requirement in the case of this license?
A PDF of the joint comments filed is available here: KEI_Comments_NIH_License_ONK_Therapeutics
(For more KEI comments on NIH licenses, see: https://www.keionline.org/nih-licenses)