(Update: The NIH provided a response to our questions and comments on February 28, 2022)
On February 9, 2022, Knowledge Ecology International (KEI) filed comments with the National Institutes of Health regarding the “Prospective Grant of Exclusive Patent License: Development and Commercialization of Regulatory T-Cell Therapies for the Treatment of Multiple Sclerosis (MS)” (87 FR 3832). The technology to be licensed is “a method for producing or growing cell populations that are enriched for stable, highly suppressive regulatory T cells (Tregs),” towards developing and commercializing a cell therapy for the treatment of multiple sclerosis.
The proposed exclusive license will be worldwide, and is to be given to TeraImmune, Inc. KEI has previously commented on a prospective license to the Maryland-based company in February 2020, for another T cell therapy – that one to treat a type of hemophilia.
On January 27, 2022, KEI asked questions regarding the technology to be licensed and offered preliminary comments (included below). KEI asked:
- What is the stage of development of the licensed inventions?
- Has the NIH funded any of the trials so far, or does it plan to?
The NIH did not provide any response to the questions until well after the comment deadline, when it offered the information in its letter of acknowledgement and response to our full comments which were filed on February 9, 2022.
A PDF of KEI’s full comments is available here: KEI-Comments-NIH-License-TeraImmune-9Feb2022
KEI Preliminary Comments: Jan 27
Dr. Yogikala Prabhu,
Technology Transfer and Patent Specialist,
Technology Transfer and Intellectual Property Office,
National Institute of Allergy and Infectious Diseases,
Email: prabhuyo@niaid.nih.gov.
Dear Dr. Prahbu,
KEI has a few comments on the proposed license.
1. The license should have a clause on pricing is consistent with the objectives of the President’s views on drug pricing, which is that US should not pay the highest prices in the works, and
2. The license should include language to ensure that it is consistent with Executive Order 13948 of September 13, 2020, titled “Lowering Drug Prices by Putting America First.”
3. The license should be non-exclusive for any country with less than 1/3 the per capita income of the United States, as measured by the World Bank Atlas method.
4. The license should require the company to make public the prices, revenues and quantities sold by country, consistent with the WHO set out in WHA72.8, May 2019, “Improving the transparency of markets for medicines, vaccines, and other health products.”
5. The NIH should enter into an agreement with the Medicines Patent Pool for using the patented inventions in developing countries.