KEI Comments Regarding NIH Proposed Exclusive License to Yeda

(Update: The NIH provided the following response on July 30, 2021.)

Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health’s (NIH) National Cancer Institute (NCI) regarding the “Prospective Grant of an Exclusive Patent License: High ASS1 Expressing Tumors Embody a Purine Rich Genomic Signature and Sensitivity to Purine Depletion” (86 FR 36567).  The technology is to be licensed to Yeda Research & Development Co, Ltd (YEDA). YEDA is described in the Federal Register notice as “the technology transfer company of the Weizmann Institute of Science, a non-profit research institution located in Rehovot, Israel.”

The invention concerns the treatment of high argininosuccinate synthase (ASS1)-expressing solid tumors with a combination of purine-related technology and checkpoint inhibitors, and the scope of the propsed license is to be worldwide, exclusive, and sublicensable. The rights to the instant technologies are currently jointly owned by YEDA and the US government, and the exclusive license is intended to expedite the commercialization of the invention.

Tumors expressing ASS1 are seen in a variety of types of cancers, and as the license is sublicensable, it is particularly important that the NIH includes terms in this license that ensure any resultant treatment is affordable and accessible to patients.

In our comments, KEI suggests that the NIH include a provision in the license (to be included in any sublicense) that requires that any medical technology using the patented invention be available in the United States at a price that does not exceed the median price in the seven largest economies by GDP that have at least 50 percent of the GNI per capita as the United States, using the World Bank Atlas method. This provision would be a modest safeguard. The US government has recently incorporated similar terms in agreements related to COVID-19 vaccines and other technology contracts.

A PDF of KEI’s full comments is available here: KEI-Comments-NIH-License-Yeda-27July2021