On April 19, 2018, KEI filed a lawsuit against the National Institutes of Health (NIH) to block or invalidate an exclusive license of patents on a new chimeric antigen receptor T-cell (CAR T) therapy to Gilead Sciences. A copy of the complaint is available here:
The license in question involves a set of patent applications regarding the development of a CD30 chimeric antigen receptor (CAR)-based immunotherapy using autologous (meaning one individual is both the donor and the recipient) T-cells, for the treatment of:
- Hodgkin lymphoma (HL),
- Non-Hodgkin’s Lymphoma (NHL),
- diffuse large B cell lymphoma (DLBCL),
- peripheral T cell lymphoma not otherwise specified (PTCL–NOS),
- anaplastic large cell lymphoma (ALCL), and
- angioimmunoblastic T cell lymphoma (AITL).
The complaint stems from (1) the NIH’s refusal to entertain an appeal from KEI on its intention to proceed with the proposed license even prior to KEI submitting the appeal itself, and (2) the self-proclaimed assertion by NIH that it is exempt from the requirement under 40 U.S.C. § 599 that creates a black letter obligation on federal agencies to seek the antitrust advice of the Attorney General prior to the disposal of federal property.
The complaint asserts that these acts constitute violations of the relevant law and regulations, including the Administrative Procedure Act.
The lawyers for KEI were Andrew Goldman of KEI, and Daniel Doty, an attorney in private practice in Baltimore.
For some additional context, see:
2018. January 5. Briefing note on NIH proposed license to Gilead for CD-30 CAR T technology, KEIOnline.Org
2018. February 27. KEI Appeals NIH/NCI Decision to Proceed with License of CD30 CAR T technology to Gilead/Kite, KEIOnline.Org
Note also that last year Gilead paid $11.9 billion to buy Kite Pharma, whose main assets were CD19-directed genetically modified autologous T-cell immunotherapy patents licensed from the NIH, and Celgene recently spent $9 billion to buy Juno Therapeutics, whose main assets were also CAR T technologies also invented on NIH grants. In the current case the NIH is giving Gilead an exclusive license on CD30-directed genetically modified autologous T-cell immunotherapy patents, on the cheap, with no requirements on pricing or access.
Note further than the prices for the first two CAR T treatments ($475,000 for Kymriah and $373,000 for Yescarta) were so high that access has been limited.