[Ip-health] NIH invented Vaccine Respiratory syncytial virus (RSV)

Jamie Love james.love at keionline.org
Sat Mar 5 09:38:19 PST 2016


Diane Singhroy and I have been working on comments to the NIH on a proposal
by the NIH to give Sanofi exclusive rights to a large portfolio of patents
related to an NIH invented vaccine for the Respiratory syncytial virus
(RSV).

Public comments are due on Tueday, March 8.  As described below by the NIH
and confirmed by Diane's research, this appears to be an important vaccine,
and the NIH has spent many years and lots of money to take
the development very far.

We filed a request for information with the NIH licensing/information
contact person on February 22, the very day the Federal Register notice was
published.  The NIH has not been responsive to our requests for
information, canceled the one scheduled telephone call with the NIH
licensing contact, and refused to even provide copies of the
patent applications, information on the trials that have been done on
the vaccines, or discuss the terms of the licenses.

We want the NIH to delay the grant of the licenses until the NIH can
explain (1) what it would cost to complete the vaccine development itself
and provide open licenses to the patents,  or (2) provide licensing terms
that protect US residents on the pricing of the vaccine, and show how the
vaccines will be affordable and available in developing  countries.   This
may be a game changing vaccine for a a virus that globally causes 199,000
deaths in children under 5, and 125 hospitalizations per year in the United
States alone.

Let me or Diane (diane.singhroy at keionline.org) know if any groups
(including any groups working on child health in developing countries) want
to join us in our comments to the NIH.  Jamie

--------------

https://www.federalregister.gov/articles/2016/03/07/2016-04884/hikma-pharmaceuticals-plc-analysis-to-aid-public-comment?utm_campaign=subscription+mailing+list&utm_medium=email&utm_source=federalregister.gov

[snip]

Respiratory syncytial virus (RSV) is the most important cause of viral
acute lower respiratory infection (ALRI) in infants and children worldwide
and is responsible for over 30 million new ALRI episodes worldwide and up
to 199,000 deaths in children under five (5) years old. In the United
States, the virus infects nearly all children at least once by the age of
two (2) and is the most common cause of bronchiolitis and infant pneumonia,
causing up to 125,000 hospitalizations of children each year. RSV disease
burden is less understood in the developing world, but available data
indicates that the virus causes a significant proportion of childhood ALRI
in these parts of the world, particularly in the first months of life. The
drug palivizumab (Synagis) can help prevent RSV disease in high risk
infants, but it cannot treat or cure already-serious RSV infection. No
vaccine exists today to prevent RSV due to an incomplete understanding of
the body's immune response to the virus, which has challenged and delayed
RSV vaccine development efforts.

The methods and compositions of this invention provide a means for
prevention of RSV and/or parainfluenza virus (PIV) infection by
immunization with live attenuated, immunogenic viral vaccines against RSV
and/or PIV.

The prospective exclusive license will be royalty bearing and will comply
with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The
prospective exclusive license may be granted unless, within fifteen (15)
days from the date of this published Notice, NIH receives written evidence
and argument that establishes that the grant of the license would not be
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.

The field of use may be limited to live attenuated vaccines against
respiratory syncytial virus (RSV) and/or parainfluenza virus (PIV)
infections in humans.

Properly filed competing applications for a license filed in response to
this notice will be treated as objections to the contemplated license.
Comments and objections submitted in response to this notice will not be
made available for public inspection, and, to the extent permitted by law,
will not be released under the Freedom of Information Act, 5 U.S.C. 552.

-- 
James Love.  Knowledge Ecology International
http://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



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