KEI Comments Regarding NIH Proposed License T Cell Cancer Therapy to Moonlight Bio

On October 12, 2023, Knowledge Ecology International (KEI) filed comments regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Engineered T Cell Therapies for the Treatment of Cancer” by the National Institutes of Health (NIH) to Moonlight Bio, Inc. of Seattle, Washington.

The worldwide, exclusive license would cover the “Development, manufacture and commercialization of autologous T cell therapy products genetically engineered to express a P53 R175H-reactive TCR claimed in the Licensed Patent Rights for the treatment of cancer in humans.”

KEI’s comments note that Moonlight Bio is an established entity with notable scientific qualifications and investor backing, and that the technology is in the pre-clinical stage of development, and some exclusivity is merited. However, the license should:

  1. Limit the scope of exclusive rights to that which is reasonably necessary (a requirement of 35 USC 209),
  2. Protect patients in the USA from pricing discrimination and/or excessive pricing, and
  3. Include measures to transfer technology to entities that will make treatments more affordable in developing countries.

The comments also highlight recent contracts between HHS and companies in which the companies have agreed to reference pricing terms, including Most Favored Nation or Most Favored Customer clauses in COVID-19 technology contracts.

KEI’s full comments are available via PDF here: KEI-Comments-NIH-License-Moonlight-Bio-12Oct2023