NIH asked to extend comments on proposed license to Atara Biotherapeutics for patents on Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer

On July 9, 2018, KEI asked the NIH to extend the deadline for comments described on the Federal Register notice 83 FR 30448 until information about the enrollment and costs of NIH-funded clinical trials involving mesothelin expressing cancers, and trials involving chimeric antigen receptor modified T-cells (CAR T), has been made publicly available. As it stands, the comment period for this prospective grant of an exclusive license closes on July 13, 2018.

A PDF of the letter is available here:

On June 29, 2018, KEI filed a FOIA request for the information mentioned above. KEI asked for an expedited processing of this FOIA request on the grounds that there is a compelling need to obtain and disseminate the information in advance of the deadline for public comments on 83 FR 30448, because the information is critical in order for the public to make informed comments. A PDF copy of this FOIA request is available here:

Today KEI received a response from the NIH acknowledging the receipt of our FOIA request, but denying the request for expedited processing. It is highly unlikely that the information requested will be available on or before July 13, 2018, when the comment period for 83 FR 30448 closes. Therefore, we believe that the current deadline should be extended and the information on the clinical trials be made publicly available in order to properly assess whether the prospective exclusive license complies with 35 U.S.C. § 209.

Last week, in a response to an email sent by KEI, the NIH Licensing and Patenting Manager, Dr. Rose M. Freel suggested there are two trials in recruitment phase at Memorial Sloan Kettering concerning the technology at issue in 83 FR 30448.

KEI noted the high price that Novartis set for tisagenlecleucel (TN Kymriah) was justified to the public on the unverifiable claim that Novartis spent $1 billion on the development of the procedure, and noted that “the fact that the NIH is sponsoring many CAR T trials means the NIH itself is in possession of information that can be used to understand the actual R&D costs required to commercialize the licensed CAR T invention.”

KEI told the NIH that “Understanding the extent to which federal funds have subsidized the development of a patented inventions, and knowing how expensive it is to make the additional investments needed for FDA approval, is critical to the determination of the scope of exclusivity that would be warranted under 35 U.S.C. § 209, as well as the leverage that the federal government has to demand access and affordability in any license to be executed,” and requested “ the deadline for comments on 83 FR 30448 be extended until the information requested has been made publicly available.”