KEI Comment to the NIH Regarding Exclusive License of Anti-Viral Prevention and Treatment

On Wednesday January 12, 2022, Knowledge Ecology International (KEI) submitted comments to the National Institutes of Health (NIH) regarding a prospective exclusive, sublicensable license to the University of Louisville Research Foundation (ULRF), for “Griffithsin Compositions for Treatment and Prevention of Anti-Viral Infections” (86 FR 73792).  The inventions to be exclusively licensed pertain to anti-viral therapies for enveloped virus infections (for example HIV, SARS-CoV, Ebola virus, and more).

ULRF is a Kentucky 501(c)3 non-profit corporation that is the agent of the University of Louisville (“UofL”) for licensing intellectual property owned and controlled by ULRF on behalf of UofL. The rights to the inventions are currently jointly held by the Government of the United States of America, the University of Louisville Research Foundation, Inc. or the University of Pittsburgh, and the license proposed is explicitly for the purposes of consolidating the patent rights to ULRF for commercial development and marketing.

Given the global incidence of the types of diseases the inventions intend to prevent and treat, KEI highlight in its comments to the NIH that the NIH needs to include provisions in the licensing agreement to ensure the objective of “broad accessibility for developing countries,” a goal expressed in the United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300*, PHS Licensing Policy.

KEI’s full comments to the NIH follow below.


———- Forwarded message ———
From: James Love <james.love@keionline.org>
Date: Wed, Jan 12, 2022 at 9:28 PM
Subject: Prospective Grant of Exclusive Patent License: “Griffithsin
Compositions for Treatment and Prevention of Anti-Viral Infections”
To: Taryn Dick

Cc: Claire Cassedy

Taryn Dick, Ph.D., MBA,
Licensing and Patenting Manager
Email: taryn.dick@nih.gov.
Re: Document Citation: 86 FR 73792

These are comments on the Prospective Grant of Exclusive Patent License: “Griffithsin Compositions for Treatment and Prevention of Anti-Viral Infections.” We appreciate the value in consolidating the rights in the patents, but this isn’t the only issue the NIH needs to consider.

The inventions have relevance for HIV, SARS-CoV, Ebola, and other diseases that have a global incidence.

The United States Public Health Service Technology Transfer Policy Manual, Chapter No. 300*, PHS Licensing Policy states: “PHS seeks to promote commercial development of inventions in a way that provides broad accessibility for developing countries.”

It’s pretty obvious that there are plenty of cases where restrictive licensing policies have not led to “broad accessibility for developing countries,” and the current COVID crisis illustrates several where restrictive licensing has led to unequal access.

Because it is completely predictable that some companies will engage in practices that undermine broad access, the NIH needs to include provisions in the licensing agreement to ensure the objective of “broad accessibility for developing countries” actually happens, and is not some bogus virtue signaling in a government manual that the NIH staff routinely ignores.

Jamie

*https://www.ott.nih.gov/sites/default/files/documents/policy/pdfs300-policy.pdf


James Love. Knowledge Ecology International
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