[Ip-health] KEI, UACT, UAEM, and SSW Appeal NIH Grant of Exclusive Licenses on CAR Cancer Therapy to Gilead/Kite
claire.cassedy at keionline.org
Thu Sep 12 08:40:56 PDT 2019
KEI, UACT, UAEM, and SSW Appeal NIH Grant of Exclusive Licenses on CAR
Cancer Therapy to Gilead/Kite
Posted on September 12, 2019 by Claire Cassedy
On September 12, 2019, Knowledge Ecology International (KEI), Union for
Affordable Cancer Treatment (UACT), Universities Allied for Essential
Medicines (UAEM), Social Security Works (SSW), and Clare Love filed an
appeal with the National Institutes of Health (NIH). The signatories
appealed the decision of the NIH to grant exclusive licenses to Kite
Pharma, Inc. (a wholly-owned subsidiary of Gilead Sciences) for chimeric
antigen receptor (CAR) technologies to treat to B-cell derived human
cancers, which include Non-Hodgkins Lymphoma (NHL), acute lymphoblastic
leukemia (ALL) and chronic lymphocytic leukemia (CLL) .
The two exclusive licenses concern different therapy types (allogeneic
versus autologus) using the same technology, “Bicistronic Chimeric Antigen
Receptor (CAR) Constructs Targeting CD19 and CD20,” as described in 84 FR
33270 and 84 FR 33272. KEI, UACT, UAEM, SSW, and Clare Love filed comments
in response to the Federal Register notices.
The NIH response to our comments stated that the NIH intended to proceed
with the exclusive licenses to Gilead/Kite. Our subsequent appeal addresses
six important issues:
1. Did the NIH properly evaluate the necessity of granting an exclusive
license, for example, by considering other incentives such as FDA
regulatory protection of test data, and patent protection from non-NIH
2. Assuming that the NIH can establish that an exclusive license was
necessary in this case, did the NIH meet its statutory responsibility to
limit the scope of rights to that which is “reasonably necessary” to induce
the investment required to bring the invention to practical application,
for example by analyzing the expected costs of investment and annual
revenues to determine how many years of exclusivity are warranted?
3. Did the NIH request the antitrust advice of the Attorney General,
pursuant to 40 U.S.C. § 559?
4. Will the licenses tend to substantially lessen competition by creating
undue market concentration, in violation of 35 U.S.C. § 209(a)(4)?
5. Was the public’s right to evaluate a proposed license under 35 U.S.C. §
209(e) undermined by the NIH’s lack of transparency?
6. Has the NIH done anything to implement the objectives in the Public
Health Service (PHS) Technology Transfer Policy Manual regarding promoting
access in developing countries?
Please see below for a PDF of the full appeal submitted, for copies of the
attachments referenced in the appeal, please visit the post on KEI's
Administrative Appeal, NIH Licenses to Kite in Bicistronic Chimeric Antigen
Receptor (CAR) Constructs Targeting CD19 and CD20,
Knowledge Ecology International
1621 Connecticut Avenue NW
Washington, DC 20009
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