(More on government funded inventions here. Other KEI comments on NIH licenses are found here.)
Susan Ano, Ph.D., NINDS Technology Transfer,
31 Center Drive, Suite 8A52, MSC2540
Bethesda, MD 20892;
Telephone: (301) 435-5515;
anos@mail.nih.gov
Dear Dr. Ano,
I am writing to express our objection to the grant of an exclusive license to AestasRx Inc., for patents related to the technologies noticed in the federal register under this title:
Prospective Grant of Start-up Exclusive License: Therapeutics and PMA-Approved Diagnostics for Alzheimer’s Disease (intranasal delivery), Parkinson’s Disease, Neuropathy,Neuropathic Pain, Peripheral Neuropathy, Diabetic Neuropathy, Neurapraxia, Axonotmesis and Neurotmesis
https://federalregister.gov/a/2016-08097
Before the NIH issues any license to AestasRx Inc. for these technologies, we request the NIH to provide the public with evidence of the following:
1. That the NIH has determined an an exclusive license is necessary for the development of the patented inventions, and there exists a written analysis which establishes that this evaluation has been done.
2. That the scope of the exclusive rights meet the requirement of 404.7(a)(1)(ii)(D), that
“The proposed terms and scope of exclusivity are not greater than reasonably necessary to provide the incentive for bringing the invention to practical application or otherwise promote the invention’s utilization by the public;”
In this regard, please provide KEI with any economic analysis if any that was used to determine the number of years of exclusivity to be licensed, or to evaluate any other terms relevant to the licenses terms and scope of exclusivity.
3. That the license provides sufficient assurances that U.S. consumers will not pay more than consumers in other high income countries, and that the products based upon the patented invention will be available at affordable prices in the United States, and at affordable prices in developing countries.
KEI also requests under the Freedom of Information Act (FOIA) all correspondence, commentary and analysis of the proposed exclusive licensing from all parties within and outside of the government.
We (KEI) waives all objections to releasing this communication under FOIA.
Sincerely,
James Love
Director
Knowledge Ecology International
1621 Connecticut Avenue, Suite 500
Washington, DC 20009
James.Love@keionline.org
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James Love. Knowledge Ecology International
https://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, twitter.com/jamie_love