(Update: The NIH provided a response to our comments on August 24, 2020)
On August 20, 2020, Knowledge Ecology International (KEI) submitted comments regarding the prospective grant of an exclusive license by the National Institutes of Health (NIH) to PreciThera, Inc. The Federal Register notice announcing the license was titled, “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Therapies To Treat IGF-1 Deficiency and Achondroplasia” (85 FR 47394). The technology to be licensed are types of fusion proteins that are for the treatment of short stature of humans with primary IGF-1 deficiency and
of humans with achondroplasia.
The company to receive this exclusive license, PreciThera, is based in Montreal, Canada, calling into question (among other things) how the NIH will address and enforce the Bayh-Dole U.S. manufacturing requirement in this instance.
KEI’s full comments are available here: KEI_Comments_NIH_License_PreciThera_20Aug2020
(For more KEI comments on NIH licenses, see: https://www.keionline.org/nih-licenses)