[Ip-health] Prospective Grant of an Exclusive Patent Commercialization License: Method of Treating Periodontal Disease via ENPP1 Inhibition to Petragen, a company with no web page or SEC filings.

James Love james.love at keionline.org
Fri Oct 9 14:18:46 PDT 2020


October 9, 2020

Benfeard L. Williams, II, Ph.D.
Office of Technology Transfer and Development
National Heart, Lung, and Blood Institute
National Institutes of Health
Email: benfeard.williams at nih.gov

RE: Prospective Grant of an Exclusive Patent Commercialization License:
Method of Treating Periodontal Disease via ENPP1 Inhibition to Petragen, a
company with no web page or SEC filings.

Dear Dr. Benfeard Willams,

KEI will comment on the Prospective Grant of an Exclusive Patent
Commercialization License: Method of Treating Periodontal Disease via ENPP1
Inhibition to Petragen, although, we do so without the NIH providing basic
information about the license or the company.

Lack of Transparency Regarding License or Company

KEI wrote to you on September 24, 2020, asking five questions about the
license and the company. You waited until 3pm on the last day to comment to
provide an answer, and since the answer must have taken only a few minutes
and no research, you should reflect on why you waited so long to respond,
other than to show KEI how little you value our comments. These were our
five questions, and your 3pm today non-answer to four, and a concise answer
on clinical trials:

--------- Forwarded message ---------
From: Williams, Benfeard (NIH/NHLBI) [E] <benfeard.williams at nih.gov>Date:
Fri, Oct 9, 2020 at 3:12 PMSubject: RE: Petragen, Inc., a start-up company
incorporated in the state of DelawareTo: James Love <
james.love at keionline.org>Cc: Claire Cassedy <claire.cassedy at keionline.org>,
Kathryn Ardizzone <kathryn.ardizzone at keionline.org>, Luis Gil Abinader <
luis.gil.abinader at keionline.org>
Dear Jamie Love,

Please find responses to your questions below.

1. Can you tell us who are the principals in this company, which does not
appear to have any web page or SEC filings?

To the extent any of this information may be provided in the company’s
application, it is protected as business confidential.

2. Is there any foreign ownership in the company?

To the extent any of this information may be provided in the company’s
application, it is protected as business confidential.

3. Is the NIH negotiating in parallel a waiver of US manufacturing?

We cannot confirm or deny whether we are negotiating such agreements.

4. What is the stage of development of this technology? Have there been any
clinical trials?This is an early stage technology.

There have been no clinical trials.

5. Will the NIH include any international reference pricing obligations on
the company, given the President's campaign promises on this issue?

The agreement and its royalty terms are yet to be negotiated and are
confidential to the company.

Best regards,

Benfeard Williams---
Benfeard L. Williams, II, Ph.D.
| Office of Technology Transfer and Development
National Heart, Lung, and Blood Institute | National Institutes of Health
31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479
Email: benfeard.williams at nih.gov
--------- End of Forwarded message ---------

I assume that the lack of information about the license and the company has
been guided by the policy of stonewalling from the office of the NIH
Director, as has been the case for other licenses. But for what it's worth,
it is offensive that the agency is saying that the public has no right to
know even the identity of a firm seeking a monopoly on a government funded
invention, let alone any of the terms of the license, or if you are even in
talks regarding manufacturing waivers. This of course makes a mockery of
the statutory provision in the Bayh-Dole Act to give the public an
opportunity to comment on an exclusive license before it is issued.

International Reference Pricing

The President of the United States is campaigning for a second term in
Office on the policy that U.S. residents should not pay more than other
high income countries for any drug, let alone one that is invented by the
NIH.
We ask the NIH to actually implement the policy of protecing US residents
against a form of price discrimination that would have US residents pay
more than other high income countries with significant GDP. HHS claims it
can do this with any drug, so certainly it can be managed with an NIH
invented treatment.

Sincerely,James Love
Knowledge Ecology International
https://keionline.org
james.love at keionline.org

-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
U.S. office phone +1.202.332.2670
http://www.keionline.org <http://www.keionline.org/donate.html>
twitter.com/jamie_love


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