[Ip-health] KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead

Claire Cassedy claire.cassedy at keionline.org
Wed Jul 31 11:45:58 PDT 2019


https://www.keionline.org/31269

KEI Comments on NIH Exclusive Licenses for CAR T Technologies to Kite/Gilead

Posted on July 31, 2019 by Claire Cassedy

On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted
joint comments [1] to the NIH on behalf of KEI, Social Security Watch
(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[2]” (84 FR 33272) and
“Prospective Grant of an Exclusive Patent License: Allogeneic Therapy Using
Bicistronic Chimeric Antigen Receptors Targeting CD19 and CD20[3]” (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 Kymriah.
Kymriah is also owned by Kite/Gilead and was developed from NIH-licensed
technologies[4], 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:
https://www.keionline.org/wp-content/uploads/Kite-Gilead-NIH-License-comments-29July2019.pdf


[1]
https://www.keionline.org/wp-content/uploads/Kite-Gilead-NIH-License-comments-29July2019.pdf
[2]
https://www.federalregister.gov/documents/2019/07/12/2019-14823/prospective-grant-of-an-exclusive-patent-license-autologus-therapy-using-bicistronic-chimeric
[3]
https://www.federalregister.gov/documents/2019/07/12/2019-14822/prospective-grant-of-an-exclusive-patent-license-allogeneic-therapy-using-bicistronic-chimeric
[4] https://www.keionline.org/23238


More information about the Ip-health mailing list