On November 3, 2023, Knowledge Ecology International (KEI) and Public Citizen (PC) submitted joint comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of Exclusive Patent Commercialization License: Human Monoclonal Antibodies That Broadly Target Coronaviruses” (88 FR 72088) to Leyden Laboratories B.V. Leyden Laboratories is a biotechnology firm based in the Netherlands. The proposed license would include the rights to develop and commercialize two types of products: both preventative and therapeutic products for coronavirus infections.
KEI and PC’s comments discuss the following:
Leyden appears to have the talent and resources to develop the licensed technology.
The geographic scope of the proposed exclusive license is worldwide and the PCT patent application geographic area is extremely broad, including in Africa, Asia, and Latin America. We object to the use of exclusive licenses in countries where per capita incomes are less than 30 percent of the United States.
There is a disconnect between the NIH’s use of a worldwide exclusive license and the US government’s promotion of voluntary licensing and technology transfer to increase access to medicines in developing countries.
The Bayh-Dole Act requires that government funded inventions are “available to the public on reasonable terms” and the NIH license needs to ensure this takes place.
We object to the grant of exclusivity in the U.S. market unless conditioned on an international high-income country reference pricing cap, similar to those used recently by both HHS and DOD for COVID-19 R&D and procurement contracts.
The License should require Lyden to ensure that products are registered and available in the US and all countries with an established need, if not directly from the licensee, from qualified third parties.
We ask that any exclusive license include either a mandate or an option to license inventions, regulatory test data and know-how to serve markets in countries with per capita incomes less than 30 percent of the United States.
Licenses should include to the extent possible terms to provide transparency that is consistent with the World Health Assembly Resolution 72.8.
These are the WIPO designated states for the PCT patent application:
ANNEX 1: WIPO PCT Designated States
AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CV, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IQ, IR, IS, IT, JM, JO, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, WS, ZA, ZM, ZW
European Patent Office (EPO) : AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, ME, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR
African Intellectual Property Organization (OAPI) : BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG
African Regional Intellectual Property Organization (ARIPO) : BW, CV, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SC, SD, SL, ST, SZ, TZ, UG, ZM, ZW
Eurasian Patent Organization (EAPO : AM, AZ, BY, KG, KZ, RU, TJ, TM
The full comments are available here: KEI-PC-Comments-NIH-License-Leyden-Laboratories-3Nov2023