[Ip-health] 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

Luis Gil Abinader luis.gil.abinader at keionline.org
Mon Jul 9 11:56:05 PDT 2018


https://www.keionline.org/28347

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:
https://www.keionline.org/wp-content/uploads/2018/07/KEI-July-9-2018-letter-to-Rose-M.-Freel.pdf

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:
https://www.keionline.org/28261

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.”


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