[Ip-health] NIH Prospective license to RNAceuticals

James Love james.love at keionline.org
Fri Jul 24 09:50:15 PDT 2020


The NIH has a Federal Register Notice to grant an exclusive license on
several inventions, including for N6, a Novel, Broad, Highly Potent
HIV-Specific Antibody, and 10E8, a Broadly Neutralizing Human Anti-HIV
Monoclonal Antibody capable of neutralizing most HIV-1 strains

https://www.federalregister.gov/documents/2020/07/10/2020-14836/prospective-grant-of-exclusive-patent-commercialization-license-n6-a-novel-broad-highly-potent

Public comment closes Monday, July 27.  The NIH licensing officer is on
vacation, and not available to answer questions until Monday.

The company, RNAceuticals, does not have a web page or any SEC filings.  I
found a number and called up.  I asked for information about the company,
including the names of the board members.  The man that answered (I never
got a name) said that information was private, and when I pressed him on
this, since they are seeking a license from the NIH and there is a public
comment period, he hung up on me.


There are trials now relating to N6 and 10E8, and considerable interest in
both relating to HIV.  But the license itself seems to have a broader field
of use.

The FR notice indicates that "10E8, has great potential to provide passive
protection from infection, as a therapeutic, or as a tool for the
development of vaccine immunogens."

The proposed filed of use does not mention HIV:

 (1) Administration to humans of DNA and/or RNA including without
limitation modified RNA encoding a protein or proteins, containing all or
some of the CDRs of N6 and (2) Administration to humans of DNA and/or RNA
including without limitation modified RNA encoding a protein or proteins,
containing all or some of the CDRs of 10E8.

On April 29, 2020, Van Scoyoc Associates disclosed it had been hired by
RNAceuticals to lobby Congress.  The lobbying disclosure listed Defense,
Fed Budget & Appropriations and Health Issues, and the employment of three
lobbyists on behalf of RNAceuticals, including Carlisle Clarke, Chad
Schulken and Jeffery S. Trinca.

Carlisle Clarke worked on Capitol Hill as  Majority Clerk of the Senate
Appropriations Subcommittee on Agriculture, Rural Development, Food and
Drug Administration (FDA) and Related Agencies."

Chad Schulken was the "Clerk of the Senate Military Construction, Veterans
Affairs and Related Agencies Subcommittee where he was the lead Democratic
staffer responsible for negotiating and assisting in the development of the
appropriations bill."

Jeffery S. Trinca's area of expertise is the IRS, formerly working for the
Senate Finance Subcommittee on Private Retirement Plans and Oversight of
the Internal Revenue Service.

We intend to complain about

1. the lack of information about the company seeking an exclusive license,
2. the open ended field of use.
3. The plans to grant exclusivity in developing or lower income countries
like India, South Africa, Brazil, Serbia or Russia.

and,
4. ask that US prices not be higher than other high income countries,
5. transparency of R&D costs, prices, sales, etc., and
6. that the years of exclusivity not be life of patent, if the products
general large amounts of revenue.

If anyone wants to join in the comments, let me know before the close of
day on Monday.


Jamie

The


-- 
James Love.  Knowledge Ecology International
U.S. Mobile +1.202.361.3040
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