KEI Comments Regarding NIH Exclusive License to Lyell Immunopharma for Cell Therapy Cancer Treatment

On June 8, 2021, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) concerning the “Prospective Grant of an Exclusive Patent License: Methods and Compositions for Adoptive Cell Therapy” (86 FR 27852). The inventions to be licensed concern cell therapy technologies for the treatment of cancers, and are to be licensed on an exclusive basis to Lyell Immunotherapy, which is based in San Francisco, California.

The NIH has noticed, and KEI has commented on, two previous proposed exclusive licenses to Lyell, in September 2019 and April 2020. Both previous licenses were also for inventions related to cell therapies to treat cancers, and the fields of use (there were multiple IP groups included in the license) for the April 2020 license echoed the same terms as stated in the prospective license at hand: worldwide geographic scope, and broadly for the treatment of all cancers. 

Considering these previous licenses and the broad potential patient populations included, it is critical that the NIH seek the advice of the Attorney General on whether the execution of the license would be consistent with antitrust law. Under 40 U.S.C. § 559, the agency, “shall not dispose of property to a private interest until the agency has received the advice of the Attorney General on whether the disposal to a private interest would tend to create or maintain a situation inconsistent with antitrust law.”

This includes when the NIH proposes to grant an exclusive license in federally-owned technology. In communications regarding previous licenses, the NIH has made clear to KEI that as a practice, it does not consult the Attorney General prior to issuing exclusive licenses.

In our comments, KEI requests that the NIH only proceed with this license if it has consulted the Attorney General regarding the antitrust implications of issuing the license.

KEI’s full comments regarding the exclusive license to Lyell Immunopharma are available here: KEI-Comments-NIH-Exclusive-License-Lyell-Immunopharma-8June2021