KEI Comments on NIH Prospective Exclusive License to Gilead for HIV Treatment/Cure

(Update: On November 4, 2021, the NIH provided a response to our comments on the license.)

On October 12, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the ““Prospective Grant of an Exclusive Patent License: Development of a Bispecific T Cell Engager for the Treatment and Cure of HIV-1” (86 FR 53334) to Gilead Sciences, based in Foster City, CA.

This worldwide, exclusive license covers technologies that are “for use in an HIV Bispecific T cell engager construct comprising the CD4 mD1 which will be utilized in therapeutic regimens to treat and cure people living with HIV.” If the development of the invention advances and comes to market, it would be the first cure for people living with HIV.

In our comments, KEI noted that as the NIH considers licensing this potentially very significant technology to Gilead, the NIH should include terms in the license that protect affordable, equitable access to patients in the US and around the world. Gilead has a track record of pricing its treatments -including HIV products- aggressively, and in the past, the high prices have been a barrier to the deployment of PrEP to prevent HIV infections. Further, the company has been the subject of a Congressional inquiry into its high pricing of its hepatitis C virus treatment, Sovaldi. Gilead’s CD19-targeting therapy, Yescarta (axicabtagene ciloleucel), which was also developed using technology invented by and licensed from the NIH and was the subject of a separate NIH Cooperative Research and Development Agreement (CRADA), was also aggressively priced.

Given Gilead’s track record of aggressively pricing its treatments, including other HIV-related technologies, the NIH must negotiate and include terms in this license that protect and safeguard affordable patient access to any resultant treatment. KEI strongly urges the NIH to include the following considerations and provisions in the terms of these licenses.

A PDF of KEI’s full comments is available here: KEI-Comments-NIH-License-Gilead-12Oct2021