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:
- 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 patent holders?
- 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?
- Did the NIH request the antitrust advice of the Attorney General, pursuant to 40 U.S.C. § 559?
- Will the licenses tend to substantially lessen competition by creating undue market concentration, in violation of 35 U.S.C. § 209(a)(4)?
- 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?
- 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 PDFs of the full appeal submitted, as well as the accompanying attachments:
- Administrative Appeal, NIH Licenses to Kite in Bicistronic Chimeric Antigen Receptor (CAR) Constructs Targeting CD19 and CD20
- Attachment A – Emails between Cassedy-LambertsonNIH Re: Questions, 12-16 July 2019
- Attachment B – Email Love LambertsonNIH Re: CRADA, 16 July 2019
- Attachment C – Email Love LambertsonNIH Re: Failing to Address Questions, 16 July 2019
- Attachment D – Emails Love LambertsonNIH Re: Cost to Manufacture CAR T, 17 July 2019
- Attachment E – Follow-up Email Love LambertsonNIH Re: Cost to Manufacture CAR T, 17 July 2019
- Attachment F – FR Comments Filed Re: Kite Exclusive License, 29 July 2019
- Attachment G – NIH Final Determination Exclusive License A3662019
- Attachment H – NIH Final Determination Exclusive License A3672019
- Attachment I – Email ShmilovichNIH-Ardizzone Re: Life of Patent Terms, 20 August 2019
- Attachment J – Email RogersNIH-Goldman NIH Re: Antitrust Advice, 15 February 2018