KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead (and NIH Response)

(UPDATE: The NIH provided responses to our comments on August 14, 2019: 84 FR 33272  Response and  84 FR 33270 Response)

On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted joint comments to the NIH on behalf of KEI, Social Security Works (SSW), Universities Allied for Essential Medicines (UAEM), Union for Affordable Cancer Treatment (UACT), and Clare Love, a cancer patient, regarding two proposed exclusive licences to Kite Pharma/Gilead Sciences for CAR T technologies to treat cancers.

The two licenses to be granted to Kite/Gilead were “Prospective Grant of an Exclusive Patent License: Autologus Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20” (84 FR 33272) and “Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20” (84 FR 33270).

Both licenses concern CAR T technologies that target both CD19 and CD20 proteins and are for the treatment of B-cell derived human cancers, which include Non-Hodgkins Lymphoma (NHL), acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). The dual targeting of CD19 and CD20 will provide more comprehensive therapy to these cancers than those treatments that have been approved that only target CD19, such as Yescarta. Yescarta is also owned by Kite/Gilead and was developed from NIH-licensed technologies, and was introduced at a price of $373,000 per treatment.

The joint comments chronicle our groups’ many objections to the grant of these licenses, including the anti-competitive nature of granting this license to Kite/Gilead, the lack of safeguards to ensure reasonable pricing, the lack of transparency, and the NIH’s compliance with 40 U.S.C. § 559, which requires the NIH to solicit the Attorney General’s advice regarding antitrust issues in the disposal of government property.

A PDF of the full comments can be accessed here: