On Tuesday February 9, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Certain Fusion Proteins and Their Use for the Treatment of Humans With Short Stature,” as noticed in the Federal Register (86 FR 6892). The prospective exclusive license is for inventions towards the ““the development, manufacture, distribution, sale and use of one or more fusion proteins for the treatment of humans with short stature associated with one or more genetic conditions.”
The technology is to be licensed to EpifiZa, Inc., a firm based in Montreal, Canada. As set forth in the Bayh-Dole Act, one of the requirements on the grant of exclusive licenses of federally-funded inventions is that licensees are required to “substantially” manufacture the invention in the United States. While licensees can obtain a waiver of the requirement to manufacture in the US, the NIH should factor this in while negotiating terms of any exclusive license to a foreign firm. Further, when licensing technology to a foreign firm, the NIH should take care to ensure that any resultant technology is available to US patients at a reasonable price.
KEI’s full comments regarding the license to EpifiZa are available here: KEI_Comments_NIH_License_EpifiZa_9Feb2021