On Friday April 17, 2020, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Methods and Compositions for Adoptive Cell Therapy” to Lyell Immunopharma, Inc. (85 FR 18577). The technology to be licensed involves six inventions related to adoptive cell therapy for indications “in cancer in humans.” A former NIH scientist who co-invented all six inventions in his capacity as an NIH employee is an executive officer with Lyell who joined in July 2019.
KEI objected to the exclusive license on the basis that:
- The NIH apparently has not analyzed whether exclusivity is a reasonable and necessary incentive or limited the scope of the license to not broader than necessary, as required by 35 U.S.C. § 209(a)(1)-(2);
- The NIH has not been transparent about the license, refusing to answer six out of nine questions submitted by KEI, and limiting our ability to comment on the license, which is guaranteed by 35 U.S.C. § 209(e); and
- The NIH has not sought the antitrust advice of the U.S. Attorney General with respect to the license, as required by 40 U.S.C. § 559.
A copy of KEI’s full comments regarding the exclusive license are available here: KEI_UACT_Comments_Exclusive_License_Lyell_Immunopharma_17April2020
KEI has filed objections to a previous exclusive license to be given to Lyell, regarding CAR therapies, available here: https://www.keionline.org/31713