KEI Comments on NIH Exclusive License to Ridgeback for FDA-approved Ebola Treatment

(Update: On April 30, 2021, the NIH sent a response to KEI’s comments.)

On March 30, 2021, Knowledge Ecology International (KEI) filed comments regarding the National Institute of Health (NIH) National Institute of Allergy and Infectious Diseases (NIAID), “Prospective Grant of an Exclusive Patent License: Development, Production, and Commercialization of Ebola Neutralizing Single Monoclonal Antibody for the Treatment of Ebola Virus Disease in Humans” (86 FR 14331). The field of use of the license conveys the rights to the, “development, production, and commercialization of Ebola neutralizing monoclonal antibody mAb114, as a single antibody not in combination with other monoclonal antibodies, for the treatment of Ebola virus disease in humans.”

The technology is to be licensed to Ridgeback Therapeutics, a firm whose Ebola treatment Ebanga (ansuvimab-zykl, formerly referred to as mAb114) was approved by the FDA on December 12, 2020. Ridgeback also received a priority review voucher (PRV) for the treatment as well under the material threat medical countermeasure PRV as well as an orphan drug designation and approval.

The US government provided significant support and incentives for the development of mAb114, including sponsoring and conducting key clinical trials, granting Ridgeback rights to the technical data, and agreeing to contracts worth up to $168 million. Indeed the Ridgeback press release concerning Ebanga notes,

“Ebanga development has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract Numbers 75A50119C00059 and 75A50120C00009.”

Considering the government’s investment in mAb114, Ridgeback’s rights to the technical data, the FDA approval of mAb114, and the priority review voucher claimed by Ridgeback for mAb114, we do not believe that the criteria for granting an exclusive license in the treatment are met. KEI opposes the grant of this exclusive license.

When granting patent licenses to federally-owned inventions, the NIH may only grant an exclusive license when exclusivity is a necessary incentive and must limit the scope of patent licenses, including the period of exclusivity, to that which is reasonable and necessary. 35 U.S.C. §209(a)(1)-(2). An invention requires a significantly lower level of incentive to induce commercialization when clinical trials are already completed and/or underway, the prospective licensee has rights to clinical trial data, and the licensee could bring in $168 million through contracts just to bring the invention to market — and markedly less incentive if the commercialization has already occurred. If it is the case that the invention that the NIH is proposing licensing on an exclusive basis to Ridgeback has already received FDA approval, then an exclusive license is not a reasonable and necessary incentive.

KEI is investigating the circumstances under which this prospective exclusive license for an already-on-the-market product has arisen, and will publish more on this issue.

KEI’s full comments are available here: KEI-Comments-NIH-Exclusive-License-Ridgeback-30March2021