On Friday August 4, 2023, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Development and Commercialization of Caspase Inhibitors” (88 FR 47152) to Elgia Therapeutics, Inc. Eligia is a firm based in La Jolla, CA. The technology to be licensed concerned caspase inhibitors, which could potentially be used for “the treatment of inflammatory diseases, such as hidradenitis suppurativa (HS) in humans and animals.”
KEI offered the following comments (also available as a PDF file here: KEI-Comments-NIH-License-Elgia-Therapeutics-4Aug2023).
DATE: August 4, 2023
TO: Sury Vepa, Ph.D., J.D.
Senior Licensing and Patenting Manager
Office of Strategic Alliances
National Institutes of Health
RE: Prospective Grant of an Exclusive Patent License: Development and Commercialization of Caspase Inhibitors to Elgia Therapeutics, Inc. (88 FR 47152)
Dear Dr. Sury Vepa,
We ask the NIH to provide the follow provisions in the license to Elgia Therapeutics, that was noticed in the Federal Register on July 21, 2023 (88 FR 47152)
1. Include a requirement that any product that is sold in the US market has a price that is not higher than the median price for the seven economies with the largest GDP, that have at least half of the per capita GNI as does the USA.
2. Require that any products sold in countries with a per capita income less than 30 percent of the USA, are affordably priced, and that any data, patent rights and manufacturing know how be licensed to the Medicines Patent Pool, if the company cannot provide products in developing countries at affordable prices.
3. Require the company to disclose to the NIH for viewing by the public the costs of each clinical trial used to support the registration of any product using the licensed patents.
4. Publish the full text of the patent license on the NIH website, similar to how the MPP publishes license agreements, without redactions on any of the economic terms or other terms of interest to the public.