Update: the NIH has rejected our request for expedited processing of the FOIA, on the grounds that KEI did not demonstrate “that there exists an urgency to inform the public” about the costs of the NIH CAR T or mesothelin trials. (The comment period closes on July 15, 2018).
On June 29, 2018, KEI submitted a Freedom of Information Act request to the National Institutes of Health (NIH), asking for information on the enrollment and costs of NIH funded clinical involving (a) mesothelin expressing cancers, and/or (b) trials involving chimeric antigen receptor (CAR) -modified T cells.
KEI is seeking the information on trial costs in order to comment on the NIH federal notice on a “Prospective Grant of an Exclusive Patent License: Development of an Anti-Mesothelin Chimeric Antigen Receptor (CAR) for the Treatment of Human Cancer,” 83 FR 30448.
KEI has submitted comments regularly to Federal Register notices on proposed exclusive licenses for NIH owned patents. One of the key issues raised in a prospective exclusive license concerns the scope of the rights granted, including the term of the exclusivity. KEI is of the opinion that it is illegal to grant a license for the life of a patent, if a shorter term is still a sufficient incentive to induce investments necessary to bring an invention to “practical application.” A key factual issue in such a determination is the amount of money required to conduct clinical trials. The NIH has funded at least 11 trials for mesothelin-related anti-cancer treatments, and an even larger number of CAR T trials. The enrollment and budget from these NIH funded trials provide important evidence that the NIH and third parties can examine to evaluate the reasonableness of the scope of rights granted on patents for inventions the NIH owns.
KEI has requested that our FOIA request be given expedited processing, citing the 15 day period for comments on the proposed license.