On April 28, 2022, Knowledge Ecology International (KEI) provided comments on the latest National Institutes of Health (NIH) Federal Register notice concerning licensing, the “Prospective Grant of an Exclusive Patent License: Development of Diagnostic for Imaging and Early Detection of Pancreatic Cancer and Pre-Cancerous Lesions by Targeting the Cholecystokinin-B Receptor” (87 FR 21892). The patents in the license are jointly assigned to the US government and Georgetown University, and this license is intended to consolidate the rights with Georgetown University explicitly for “commercial development and marketing.”
The technology in the proposed worldwide, exclusive, sublicensable agreement concerns the detection of precancerous lesions and would aid in the early detection and diagnosis of pancreatic cancer.
In our comments, KEI called on the NIH to make the license, and any resultant sublicenses, transparent and to include terms that ensure affordable access in the US and in developing countries.
KEI’s comments regarding the prospective license follow below.
Whitney Hastings, Ph.D.
Senior Technology Transfer Manager
Email: whitney.hastings2@nih.gov
RE: Prospective Grant of an Exclusive Patent License to Georgetown for Inventions Relating to the Development of Diagnostic for Imaging and Early Detection of Pancreatic Cancer and Pre-Cancerous Lesions by Targeting the Cholecystokinin-B Receptor (87 FR 21892)
Dear Dr. Hastings,
35 USC 209 requires that the proposed scope of exclusivity is “not greater than reasonably necessary to provide the incentive for bringing the invention to practical application, as proposed by the applicant, or otherwise to promote the invention’s utilization by the public.”
The “United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” states the following: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries.” (https://www.ott.nih.gov/sites/default/files/documents/policy/pdfs/300-policy.pdf, page 2). This policy should be given effect.
Both of these norms support our position that the NIH should normally not make patent licenses exclusive in countries with significantly lower per capita incomes than the United States. We have proposed and do propose in this case, a cut-off of 30 percent of US per capita income, as measured by the World Bank Atlas method, for exclusivity.
The NIH should consider negotiating non-exclusive licenses for developing countries through the Medicines Patent Pool.
KEI also asks that the license include a provision that provides either a most favored nation pricing clause for the U.S. market, or an alternative maximum reference price such as a median price for a group of countries with large GDP and at least 50 percent of US per capita income.
KEI asks that the license itself be transparent, similar to the Medicines Patent Pool licenses, and that the license require companies commercializing the inventions to provide the public information consistent with the suggested norms in WHA72.8.
James Love
KEI