KEI recently submitted comments to the National Institutes of Health (NIH) regarding its drastic cuts in the length of public comment periods for proposed exclusive licenses. In our comments, KEI discussed reasons that a longer comment period is important for the public to be able to offer informed input regarding the licenses. We noted that among those reasons is the issue of obtaining timely (or any) information from the NIH about the licenses beyond the very limited details provided in the Federal Register notices.
As an example, in April 2023 the NIH posted a Federal Register notice announcing their intent to grant an exclusive license to EnZeta, Inc. (FR). KEI received an alert on April 5, 2023 that the notice would be published the next day, and immediately emailed Richard Girards, Jr. (the contact listed in the notice) seeking information about EnZeta, as the firm did not appear to have a website or any other publicly available information. Mr. Girards replied on April 6, 2023 providing limited answers and directing us to search the Delaware state business registry (which yielded very limited information that we had to pay for). KEI asked further questions on April 7th, to which we did not receive a reply either before or after the comment period closed on April 21, 2023.
This exchange regarding EnZeta is one of many similar exchanges KEI has experienced when trying to obtain basic information about these exclusive licenses. While the NIH needs to also reform its current non-transparent practices, longer comment periods could aid the public in commenting effectively, but giving more opportunity for the NIH to respond and the public to push back on those responses, as well as more time to conduct in-depth research into footprint-less firms to which the NIH is conveying exclusive rights to potentially life-saving technologies.
KEI also notes that it appears the NIH has amended or expanded the terms of the exclusive license, as they published a Federal Register notice in August 2023 for nearly the same technologies, this time to EnZeta Immunotherapies, Inc. KEI has submitted questions regarding this license as well.
Text of KEI’s full exchange with the NIH follows below.
James Love Wed, Apr 5, 2023 at 10:45 AM
To: “Girards, Richard (NIH/NCI) [E]”
Cc: Claire Cassedy
Hi, is this a US subsidiary of a Swedish company? Jamie
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James Love Wed, Apr 5, 2023 at 10:46 AM
To: “Girards, Richard (NIH/NCI) [E]”
Cc: Claire Cassedy
Or a Spanish company?
https://www.zoominfo.com/c/enzeta/429702480
More generally, who is the beneficial owner of this company?
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Girards, Richard (NIH/NCI) [E] Thu, Apr 6, 2023 at 2:54 PM
To: James Love
Cc: Claire Cassedy
Hi, Jamie – no, it’s not.
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Girards, Richard (NIH/NCI) [E] Thu, Apr 6, 2023 at 2:55 PM
To: James Love
Cc: Claire Cassedy
Dear Jamie – no, on this point as well.
————————————-
James Love Thu, Apr 6, 2023 at 3:22 PM
To: “Girards, Richard (NIH/NCI) [E]”
Cc: Claire Cassedy
Okay. The company does not seem to have a web page, and there are no
SEC filings. What can you tell me about the company? Is it US or
foreign owned? Who is on the board of directors, or who are the key
staff? Does the company employee former NIH employees?
You published a request for comments on a license to a mystery
company. How about making this more transparent, since some unknown
company wants an exclusive patent license from the NIH.
Jamie
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Girards, Richard (NIH/NCI) [E] Thu, Apr 6, 2023 at 3:27 PM
To: James Love
Cc: Claire Cassedy
Significant, publicly-available data about the company can be accessed through the State of Delaware: https://icis.corp.delaware.gov/ecorp/entitysearch/namesearch.aspx.
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James Love Thu, Apr 6, 2023 at 5:25 PM
To: “Girards, Richard (NIH/NCI) [E]”
Cc: Claire Cassedy
This is what I got for $20. Not very useful.
[ATTACHMENT]
James Love Thu, Apr 6, 2023 at 5:49 PM
To: “Girards, Richard (NIH/NCI) [E]”
Cc: Claire Cassedy
If the relevant details about the company and the licensing terms
outside of the field of use are secret, doesn’t this undermine the
point of asking for public comment?
Jamie
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James Love Thu, Apr 6, 2023 at 5:55 PM
To: “Girards, Richard (NIH/NCI) [E]”, “Rohrbaugh, Mark (NIH/OD) [E]”
Cc: Claire Cassedy
Richard, I don’t blame you for refusing to provide any useful
information on the company. I know the NIH has taken this position in
the past, and it must be some type of stonewalling policy at a higher
level.
But given the growing criticism of the NIH for its lack of
transparency in other areas, do you or Mark think this is really good
for the agency’s standing with the public?
We are just trying to respond to the request for comments the NIH
posted on this license. When a company has no website and no SEC
files, and nothing turns up on a Google search, one would think the
NIH would appreciate that this merits more transparency about who and
what the company is.
Jamie
————————————-
James Love Thu, Apr 6, 2023 at 6:00 PM
To: “Girards, Richard (NIH/NCI) [E]”, “Rohrbaugh, Mark (NIH/OD) [E]”
Cc: Claire Cassedy
This is what I get when I go to the link for the registered agent for EnZeta.
https://www.wolterskluwer.com/en/solutions/bizfilings
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James Love Fri, Apr 7, 2023 at 7:55 AM
To: “Girards, Richard (NIH/NCI) [E]”, “Rohrbaugh, Mark (NIH/OD) [E]”
Cc: Claire Cassedy
Richard, These are questions that KEI asks regarding the license:
1. What is the state of development of the inventions? For
example,have there been any clinical trials with human subjects?
2. Will the NIH impose any obligations to make the inventions
affordable in developing countries?
3. Will the NIH impose any obligations to provide patients in the US
the most favored nations pricing or any other restrictions on pricing
to ensure that US residents don’t pay more or significantly more than
patients or most patients in other high income countries?
4. Has the NIH been asked to consider a waiver of US manufacturing
obligations under the Bayh Dole Act?
5. Are any principals of the company former NIH employees?
Jamie
https://www.federalregister.gov/documents/2023/04/06/2023-07117/prospective-grant-of-an-exclusive-patent-license-manufacture-distribution-sale-and-use-of