(Update: The NIH provided a response to our comments on April 15, 2021.)
On Wednesday April 14, 2021, Knowledge Ecology International (KEI) filed comments with the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: The Development of Natural Killer (NK) Cell Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) T Cell Receptor (TCR) Therapy for the Treatment of KK-LC-1 Expressing Human Cancers” (86 FR 16603). The technology is to be licensed to Zelluna Immunotherapy, which is based in Oslo, Norway.
The license conveys the rights to inventions concerning T-cell receptor therapy for the Kita-Kyushu Lung Cancer Antigen 1 (KK-LC-1) expressing cancers, which include triple negative breast cancer, gastric cancer, and lung cancer. The Federal Register announcement notes that there are currently no effective immunotherapies for patients with these types of tumors. In light of this, it is particularly important that the NIH ensures that the terms of this license protect equitable and affordable access to any resultant treatments. The terms included in these exclusive licenses must ensure that desperate patients without alternative treatment options are not held hostage to high prices.
Furthermore, Zelluna is a firm based in Oslo, Norway and one of the requirements of granting an exclusive license is that licensees “substantially” manufacture the invention in the United States. The NIH should factor this in while negotiating terms of any exclusive license to a foreign firm and should only grant a waiver if a compelling reason is shown.
KEI’s full comments are available here: KEI_Comments_NIH_License_Zelluna_14April2021