In an order dated April 11, 2019, Judge Peter J. Messitte granted the NIH’s motion to dismiss for lack of jurisdiction in the lawsuit filed by KEI, which appealed an NIH decision to grant an exclusive license on a CAR T cancer therapy to Gilead. During the licensing process, the NIH refused to disclose the amount of money it was spending on a 77 patient clinical trial, or to include any provisions protecting U.S. residents from prices higher than the median of other high income countries, or to include measures to ensure access in developing countries, or to consider just delaying a license until the NIH had results from its own government-funded clinical trial.
The Judge did not resolve a dispute over whether or not the Bayh-Dole Act somehow eliminates obligations in 40 U.S.C. § 599, as the NIH alleges.
The memorandum opinion is available here. The final order is available here.
(More pleadings on the case here: https://www.keionline.org/kei-v-nih)
Judge Messitte found that while “KEI is an admirable organization that undoubtedly possesses expertise in the issues going to the merits of this case,” KEI lacked organizational and associational standing to sue the NIH over the licensing decision.
Comment by James Love, KEI Director
- Judge Messitte’s decision illustrates how little influence citizens have over the licensing practices of the NIH, despite the putative opportunity to comment on proposed exclusivity licenses, and the policy and objective of the Bayh-Dole Act to “protect the public against nonuse or unreasonable use of inventions.” [35 USC § 200]. While the decision leaves the door open to challenge NIH licensing practices for a different license with different plaintiffs that can demonstrate the requisite harm, the NIH will likely become even more emboldened to ignore criticisms of its lack of transparency and failure to provide provisions to protect the public from excessive and abusive prices. At some point, Congress needs to provide real oversight of the NIH management of the public’s rights in federally-funded inventions.