On July 2, 2018, Knowledge Ecology International (KEI) filed comments to the National Institutes of Health (NIH) regarding the prospective grant of an exclusive license to the University of Liverpool, located in the U.K. The inventions described in the Federal Register notice 83 FR 28002 relate to “streptococcus pneumonia PSAA peptide for treatment of sepsis and infection”.
A PDF of the comments filed yesterday are available here:
KEI-NIH-Comments-Streptococcus-Pneumonia-Liverpool-2Jul2018
KEI’s comments propose several conditions on the exclusive license, including:
- Prices in the U.S. for any drug, vaccine, medical device or other health technology using the invention should not be higher than the median price charged in the seven countries with the largest gross domestic product (GDP), that also have a per capita income of at least 50 percent of the United States, as measured by the World Bank Atlas Method.
- The license should not be exclusive for countries with a per capita income that is less than 30 percent of the US.
- The licensee should be required to file an annual report to the NIH, available to the public, on the research and development (R&D) costs associated with the development of any product that uses the invention, including reporting separately and individually the outlays on each clinical trial;
- The exclusivity of the license in the U.S. should be reduced by one year for every $500 million in revenue equivalents, earned after the first $1 billion, where revenue equivalent is defined as global cumulative sales, plus market entry rewards as well as government grants or tax credits, for the product or products using the invention.
KEI also provided a table that identified more than $1 billion in federal research grants related to streptococcus pneumonia or streptococcus pneumoniae.
A list of previous comments on exclusive licenses over NIH-owned patents is available here. https://www.keionline.org/nih-licenses
More about KEI’s work is available here: https://www.keionline.org/ourwork