(UPDATE: The NIH provided a response to our comments on February 25, 2020)
On February 3, 2020, Knowledge Ecology International (KEI) submitted comments to the “Prospective Grant of Exclusive Patent License: Development of Regulatory T-Cell Therapies for the Treatment of Hemophilia A (HA)” (85 FR 3062). The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) announced its intent to license this T cell therapy on an exclusive basis to TeraImmune, Inc. The technology to be licensed is for the treatment NAME.
In the comments, KEI notes that the federal government has conducted the basic and preclinical research for the invention and has granted TeraImmune over $3 million to support its commercial development. Further, due to the invention’s indication in acquired Hemophilia A, a rare disorder and unmet health need, it is likely to qualify for valuable regulatory incentives such as orphan drug 2 market exclusivity and expedited FDA review. Considering that the NIH has significantly de-risked the research and development of the technology and provided valuable funding and incentives for the development of this invention, the NIH must take these factors in to account when negotiating licenses to private companies, and whether exclusive, worldwide, life-of-patent, monopoly-generating licenses are “necessary” to bring the technology to market.
A PDF of KEI’s full comments are available here: KEI_Comments_NIH_License_TeraImmune_3Feb2020
(For more KEI comments on NIH licenses, see: https://www.keionline.org/nih-licenses)