On July 18, 2025, KEI submitted comments regarding the prospective exclusive licensing by the NIH of “The Development of an in vivo Anti-CD19 Chimeric Antigen Receptor (CAR) for the Treatment or Prevention of B Cell Mediated Autoimmune Diseases” (90 FR 29571).
The NIH proposes to grant Capstan Therapeutics the exclusive rights to this technology. Recently, the company was acquired by AbbVie for over $2 billion, which indicates the potential market value of this technology.
KEI has raised multiple concerns about this, including that the license is overly broad, potentially covering the entire world. KEI has recommended that the scope be reduced to non-exclusive within the United States, urging the NIH to protect public interest. We also recommend the use of a Most Favoured Nation pricing policy to ensure reasonable pricing in the US such that it does not exceed the median price in other high-income countries.
We also urge the NIH to consider the investment the US government has already made in supporting the researchers at this company, who have received significant grants from the NIH to develop technology and further their careers, amounting to upwards of $ 250 million in public funds. The NIH should also ensure the public disclosure of trial costs and public subsidies in relation to these projects.
KEI’s full comments are available here: KEI-Comments-NIH-License-Capstan-18July2025